MIGS: Expanding realm of glaucoma

Transcription

Cutting-edge AdvAnCements
CliniCal Diagnosis
OphthalmologyTimes.com
follow us online:
special report
What diagnostics,
therapy may bring
to glaucoma care
In thIs installment of “Sight Lines,” J.C.
Noreika, MD, talks with Joel Schuman,
MD, of the Department of Ophthalmology, University of Pittsburgh Medical
Center, about the use of optical coherence tomography to diagnose and follow glaucoma in patients, as well as
the future of glaucoma care.
surgery
February 1, 2015 Vol. 40, No. 2
Drug therapy
MIGS: Expanding
realm of glaucoma
Success requires picking the right patient, setting
proper expectations, and learning technique
adopting microinvasive glaucoma surgery
( See story on page 16 : Sight Lines )
surgery
tips For taking
the crying out oF
epiphora exams
VIDEO Mastering stent implantation with the
best possible view is key. Go to http://bit.ly/1EwPdAn
The microbypass trabecular stent (iStent, Glaukos)
is viewed in place. (Photo and video courtesy of Reay H. Brown, MD)
By Cheryl Guttman Krader;
Reviewed by Reay H. Brown, MD
At l An tA ::
ne w hAven, C t :: excessIve tearing, or epiphora, is a common chief
complaint in general and subspecialty
oculoplastics practices. Michael S.
Ehrlich, MD, explains how a simple
lacrimal irrigation technique can avoid
unnecessary discomfort for patients,
and also add diagnostic value for
ophthalmologists.
( See story on page 6 : Plastics Pearls )
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CataraCt surgeons and cornea specialists have been important in the development of
microinvasive glaucoma surgery (MIGS), and they
have an important role to play in its future, according to Reay H. Brown, MD.
“When the first MIGS device was approved, the
question arose of whether it should only be implanted by glaucoma specialists,” said Dr. Brown,
in private practice, Atlanta Ophthalmology Associates. “That . . . debate . . . never got off the ground.”
Cataract and cornea surgeons should care about
MIGS, because it is within their skillset and offers
a chance for them to safely help glaucoma patients
who need cataract surgery but not a trabeculectomy
or tube surgery.
“Moreover, cataract and cornea surgeons have
an amazing record of innovation, and glaucoma
needs [their] innovative spirit,” he noted.
Speaking about combined MIGS and cataract surgery, Dr. Brown explained that by strict definition,
MIGS is performed through an ab interno incision
and is not destructive or ablative.
Based on its safety and efficacy, MIGS creates a
new paradigm for the role of surgery in glaucoma
management.
“MIGS introduces a new way of thinking about
glaucoma surgery,” he said. “In the past, surgical
intervention was considered for the 5% of patients
who were on four or more medications.”
However, with MIGS, surgery is no longer a last
resort for candidates failing maximal medical treatment with an elevated IOP and visual field progression, he explained.
( Continues on page 32 : MIGS )
ES558281_OT020115_CV1.pgs 01.23.2015 03:15
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FEBRUARY 1, 2015 :: Ophthalmology Times
3
contents
9
23
15
34
38
16
Surgery
Drug Terapy
Practice Management
6 TAKING THE CRYING OUT
OF EPIPHORA EXAMS
13 CATT: SUBRETINAL FLUID
PROTECTIVE OF VISION
44 EVERY CLINIC HAS ITS
CAST OF CHARACTERS
Technique makes irrigation
more comfortable for patients,
more informative for physicians
In Every Issue
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4
editorial
FEBRUARY 1, 2015 ◾ VOL. 40, NO. 2
CONTENT
Taking the big red bus test
What dying wishes or regrets might ophthalmologists have?
By Peter J. McDonnell, MD
director of the Wilmer Eye Institute,
Johns Hopkins University School of
Medicine, Baltimore, and chief medical
editor of Ophthalmology Times.
He can be reached at 727 Maumenee Building
600 N. Wolfe St. Baltimore, MD 21287-9278
Phone: 443/287-1511 Fax: 443/287-1514
E-mail: [email protected]
ALASTAIR MITCHELL is the youthful
chief executive of a software company called
Huddle. Noted for his success as an entrepreneur, Mitchell offers the following wisdom to
college students just starting out:
“I’d say go big or go home. And just trust yourself. Whatever your gut instinct is, you’ll probably be right seven or eight times out of 10. So just
go with your gut. We’re here for only a very short
time, so why not try to build something great?”
That makes some sense. But I wonder if everyone’s gut instincts are trustworthy. If possible, relying on good data and employing objective and verifiable solutions (e.g., evidencebased medicine) strike me as advantageous.
When faced with a difficult decision, Mitchell uses the “big red bus test.” He thinks about
walking out of his building in London and
crossing the street, only to see that one of those
monstrous double-decker red buses is literally
about to flatten him and send him to the hereafter. In the brief instant before the bus hits
him, he wonders what would be the thing he
would most regret not having accomplished.
The answer to this question should guide prioritization of the efforts of a successful chief
executive officer, businessman, or (presumably) ophthalmologist.
LAST REGRETS
What, I wondered, would I end up wishing I
had achieved in the instant before the large red
bus splatters my brains and body parts onto the
asphalt? It wouldn’t be that I’d regret not pursuing a different career, as ophthalmologists
really do help people and that is extremely rewarding. Also, the pay may not be up there
with neurosurgeons, but it is more than satisfactory, so I don’t think my dying wish would
be to have made more money.
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The organization for which I work is admired
worldwide and I am happy to be in a position to
try to contribute to its continued success.
My children are doing well.
About the only thing that occurred to me offhand is that I have never seen Florence, Italy,
and since taking my art history class in college
I have known that the works of art located in
that city demand a visit.
“Does my not having a burning uncompleted
task pop right into my head mean that I am not
ambitious enough?” I wondered.
How would others answer? I applied the big
red bus test to two successful physician friends.
Although only one is an ophthalmologist, both
are loyal Ophthalmology Times readers, undeniably a sign of profound intelligence and sophistication. In succession, but individually, I verbally
painted for my subjects the instant at which
they realize the huge magenta mass of metal is
hurtling on their all-too-frail human flesh.
“What thought leaps into mind?” I asked subject number one, eagerly awaiting his response.
“Nothing,” he replied, “because there is no
time for thinking in the brief instant during
which my cat-like reflexes cause me to leap
back onto the sidewalk, allowing me to live a
long life and accomplish many things.”
“Thanks for nothing,” I responded.
While subject number one is clearly in denial
about his mortality, I knew my second subject
to be a very thoughtful person who would not
refuse to face the reality of death. Her response,
I felt certain, would make my wanting to visit
Florence pale in significance.
I told her about Mitchell and asked what she
would most regret not accomplishing.
“Looking both ways,” she replied.
I wonder how you, dear Ophthalmology
Times reader, will answer. ■
Chief Medical Editor Peter J. McDonnell, MD
Group Content Director Mark L. Dlugoss
[email protected] 440/891-2703
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Neuro-Ophthalmology Andrew G. Lee, MD
Ophthalmic Heritage Norman B. Medow, MD
Tech Talk H. Jay Wisnicki, MD
The Glaucoma Angle Malik Y. Kahook, MD
Uveitis Update Emmett T. Cunningham Jr., MD, PhD, MPH
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February 1, 2015 :: Ophthalmology Times
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Chief Medical Editor
Peter J. McDonnell, MD
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD
Anne L. Coleman, MD
Joan Miller, MD
Jules Stein Eye Institute, UCLA
Los Angeles, CA
Massachusetts Eye & Ear Infirmary
Harvard University
Boston, MA
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Harvard & Tufts Universities
Boston, MA
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Los Angeles, CA
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Chicago, IL
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Wilmer Eye Institute, Johns Hopkins University
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University of Minnesota,
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University of Utah
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Ophthalmology Times’ vision is to be the leading content resource for ophthalmologists.
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PAGE 11
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e 01 |
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2012
ES555919_OT020115_005.pgs 01.20.2015 02:29
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6
February 1, 2015 :: Ophthalmology times
surgery
Tips for taking the crying
out of epiphora case exams
Technique makes irrigation more comfortable for patients, more informative for physicians
plastics pearls By michael s. ehrlich, md
Ne w HaveN, C T ::
xcessive tearing, or epiphora,
is a common chief complaint
in general and subspecialty
oculoplastics practice.
Causes of epiphora can be
broadly classified into ocular surface disorders, eyelid
malposition, nasolacrimal duct obstruction,
and canalicular obstruction. Extensive history taking should be undertaken to narrow down the differential diagnosis. Specific
questions of medication history, sinus disease, trauma, infection, and chronicity can
be helpful.
Even after a careful history, however, the
majority of these patients require lacrimal
irrigation to determine the anatomic cause
of the patients’ symptoms, as well as to formulate a medical and/or surgical plan.
Patients are often referred to our subspecialty practice having previously undergone
diagnostic lacrimal irrigation in the past.
After explaining that it is necessary to irrigate their lacrimal system not only to confirm a blockage, but also to observe the pattern of reflux, patients are often still hesitant. Why?
IrrIgatIOn tEchnIquE
e
VIDEO
watch a brief video
demonstration of an
irrigation technique
without dilation.
Go to http://bit.
ly/1L0BQgj
(Video courtesy
of Michael S.
Ehrlich, MD)
(Figure 1) The 30-gauge cannula fts directly
into the puncta. Fluid can be passed into the
lacrimal system without the traditional dilation
and 90° lateral turn. If resistance is met, the
bent cannula can be advanced in the usual
manner. (Photo courtesy of Michael S. Ehrlich, MD)
mal system. Patients may report significant
painful pressure during both dilation and
irrigation.
eliminating
unnecessary step
In 90% of cases, the dilation step is unnecessary. Instead, I use the following
technique:
a d d i n g d i ag n o s t i c va l u e
Place a drop of proparacaine into the forThe traditional method of dilation and irrinix. Screw a 30-gauge disposable anterior
gation can be quite uncomfortable. A simple
chamber cannula with a 6-mm bend (Wilirrigation technique is one that patients reson Ophthalmic) onto a luer-lock 3-cc syport to be comfortable and
ringe. Fill the syringe with
that I find to add diagnostic
irrigating fluid. A sterile convalue.
tact lens solution is my prefTraditional lacrimal irrigaerence, because it is easy
Michael S. Ehrlich,
tion cannulas range in size
for the patient to taste in the
MD, explains how
from 21 to 25 gauges. This
throat.
a simple lacrimal
large size often requires the
The 30-gauge cannula fits
irrigation technique
punctum and upper canalicdirectly into the puncta (Fignot only can avoid
ulus to be dilated before the
ure 1). Fluid can be passed
unnecessary
cannula will fit.
into the lacrimal system
discomfort for
Once dilated, the large
without the traditional dilapatients, but also
size of the cannula requires
tion and 90° lateral turn. If
adds diagnostic value
a 90° turn laterally to allow
resistance is met, the bent
for ophthalmologists.
laminar flow into the lacricannula can be advanced in
Take-Home
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the usual manner. This technique is particularly informative in cases where there is an
initial partial blockage noted with the 30gauge cannula. The punctum is dilated and
irrigation is repeated. If improved flow is
noted, the patient will benefit from a punctual-enlarging procedure, such as a threesnip punctoplasty.
After undergoing an irrigation technique
without dilation, patients often may wonder
“why it had to hurt so much when the other
doctor did it.” ■
what technique for lacrimal irrigation
has been benefcial for patients in clinic?
Join the discussion at Facebook.com/
OphthalmologyTimes
Michael S. Ehrlich, MD, is assistant professor of ophthalmology, and
director, oculoplastics and orbital surgery, Yale Eye Center, New Haven,
CT. He did not indicate a fnancial interest in the subject matter.
ES557277_OT020115_006.pgs 01.22.2015 02:20
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ES557996_OT020115_007_FP.pgs 01.23.2015 00:40
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ALPHAGAN® P
(brimonidine tartrate ophthalmic solution)
0.1% and 0.15%
BRIEF SUMMARY
Please see ALPHAGAN® P package insert for full prescribing information.
INDICATIONS AND USAGE
ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is an alpha adrenergic
receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension.
CONTRAINDICATIONS
Neonates and Infants (under the age of 2 years)
®
ALPHAGAN P is contraindicated in neonates and infants (under the age of 2 years).
Hypersensitivity Reactions
ALPHAGAN® P is contraindicated in patients who have exhibited a hypersensitivity reaction to
any component of this medication in the past.
WARNINGS AND PRECAUTIONS
Potentiation of Vascular Insufficiency
ALPHAGAN® P may potentiate syndromes associated with vascular insufficiency.
ALPHAGAN® P should be used with caution in patients with depression, cerebral or coronary
insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Severe Cardiovascular Disease
Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure
of patients in clinical studies, caution should be exercised in treating patients with severe
cardiovascular disease.
Contamination of Topical Ophthalmic Products After Use
There have been reports of bacterial keratitis associated with the use of multiple-dose containers
of topical ophthalmic products. These containers had been inadvertently contaminated by patients
who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial
surface (see PATIENT COUNSELING INFORMATION).
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates
observed in the clinical studies of a drug cannot be directly compared to rates in the clinical
studies of another drug and may not reflect the rates observed in practice.
Adverse reactions occurring in approximately 10-20% of the subjects receiving brimonidine
ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and
eye pruritus. Adverse reactions occurring in approximately 5-9% included: burning sensation,
conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
Adverse reactions occurring in approximately 1-4% of the subjects receiving brimonidine
ophthalmic solution (0.1-0.2%) included: abnormal taste, allergic reaction, asthenia, blepharitis,
blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival
hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye
dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular
conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia,
hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder,
pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial
punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous
floaters, and worsened visual acuity.
The following reactions were reported in less than 1% of subjects: corneal erosion, hordeolum,
nasal dryness, and taste perversion.
Postmarketing Experience
The following reactions have been identified during postmarketing use of brimonidine tartrate
ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of
unknown size, estimates of frequency cannot be made. The reactions, which have been chosen
for inclusion due to either their seriousness, frequency of reporting, possible causal connection to
brimonidine tartrate ophthalmic solutions, or a combination of these factors, include: bradycardia,
depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions
(including erythema, eyelid pruritus, rash, and vasodilation), syncope, and tachycardia. Apnea,
bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression,
and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic solutions.
DRUG INTERACTIONS
Antihypertensives/Cardiac Glycosides
Because ALPHAGAN® P may reduce blood pressure, caution in using drugs such as
antihypertensives and/or cardiac glycosides with ALPHAGAN® P is advised.
CNS Depressants
Although specific drug interaction studies have not been conducted with ALPHAGAN® P, the
possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates,
opiates, sedatives, or anesthetics) should be considered.
Tricyclic Antidepressants
Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine.
It is not known whether the concurrent use of these agents with ALPHAGAN® P in humans can
lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking
tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
Monoamine Oxidase Inhibitors
Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine
and potentially result in an increased systemic side-effect such as hypotension. Caution is advised
in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category B: Teratogenicity studies have been performed in animals.
Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in
black
rats and days 6 through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg
/kg/day) and rabbits (5.0 mg/kg/day) achieved AUC exposure values 360- and 20-fold higher,
or 260- and 15-fold higher, respectively, than similar values estimated in humans treated with
ALPHAGAN® P 0.1% or 0.15%, 1 drop in both eyes three times daily.
There are no adequate and well-controlled studies in pregnant women; however, in animal
studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent.
Because animal reproduction studies are not always predictive of human response, ALPHAGAN® P
should be used during pregnancy only if the potential benefit to the mother justifies the potential
risk to the fetus.
Nursing Mothers
It is not known whether brimonidine tartrate is excreted in human milk, although in animal
studies, brimonidine tartrate has been shown to be excreted in breast milk. Because of the
potential for serious adverse reactions from ALPHAGAN® P in nursing infants, a decision should
be made whether to discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
Pediatric Use
ALPHAGAN® P is contraindicated in children under the age of 2 years (see CONTRAINDICATIONS).
During postmarketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia,
hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants
receiving brimonidine. The safety and effectiveness of brimonidine tartrate have not been studied
in children below the age of 2 years.
In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years)
the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution
0.2% dosed three times daily were somnolence (50-83% in patients ages 2 to 6 years) and
decreased alertness. In pediatric patients 7 years of age (>20 kg), somnolence appears to occur
less frequently (25%). Approximately 16% of patients on brimonidine tartrate ophthalmic solution
discontinued from the study due to somnolence.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and other
adult patients.
Special Populations
ALPHAGAN® P has not been studied in patients with hepatic impairment.
ALPHAGAN® P has not been studied in patients with renal impairment. The effect of dialysis on
brimonidine pharmacokinetics in patients with renal failure is not known.
OVERDOSAGE
Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse
reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been
reported in neonates, infants, and children receiving ALPHAGAN® P as part of medical treatment
of congenital glaucoma or by accidental oral ingestion (see USE IN SPECIFIC POPULATIONS).
Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway
should be maintained.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
No compound-related carcinogenic effects were observed in either mice or rats following a
21-month and 24-month study, respectively. In these studies, dietary administration of
brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1 mg/kg/day in rats achieved 150
and 120 times or 90 and 80 times, respectively, the plasma Cmax drug concentration in humans
treated with one drop of ALPHAGAN® P 0.1% or 0.15% into both eyes 3 times per day, the
recommended daily human dose.
Brimonidine tartrate was not mutagenic or clastogenic in a series of in vitro and in vivo studies
including the Ames bacterial reversion test, chromosomal aberration assay in Chinese Hamster
Ovary (CHO) cells, and three in vivo studies in CD-1 mice: a host-mediated assay, cytogenetic
study, and dominant lethal assay.
Reproduction and fertility studies in rats with brimonidine tartrate demonstrated no adverse
effect on male or female fertility at doses which achieve up to approximately 125 and 90 times
the systemic exposure following the maximum recommended human ophthalmic dose of
ALPHAGAN® P 0.1% or 0.15%, respectively.
PATIENT COUNSELING INFORMATION
Patients should be instructed that ocular solutions, if handled improperly or if the tip of the
dispensing container contacts the eye or surrounding structures, can become contaminated
by common bacteria known to cause ocular infections. Serious damage to the eye and
subsequent loss of vision may result from using contaminated solutions (see WARNINGS AND
PRECAUTIONS). Always replace the cap after using. If solution changes color or becomes
cloudy, do not use. Do not use the product after the expiration date marked on the bottle.
Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular
condition (e.g., trauma or infection), they should immediately seek their physician’s advice
concerning the continued use of the present multidose container.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least
five minutes apart.
As with other similar medications, ALPHAGAN® P may cause fatigue and/or drowsiness in some
patients. Patients who engage in hazardous activities should be cautioned of the potential for a
decrease in mental alertness.
Rx Only
Revised: 11/2011
© 2012 Allergan, Inc.
Based on package insert 71816US15C
Irvine, CA 92612, U.S.A.
®
marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
APC57BC13
ES557984_OT020115_008_FP.pgs 01.23.2015 00:40
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9
surgery
Strategies for surgical intervention
aid in peripheral corneal disease
How C- or banana-shaped grafts can help maintain corneal integrity and contour
by lynda charters; Reviewed by Donald Tan, FRCSE, FRCSG, FRCOphth
has been Dr. Tan’s experience that tectonic
urgical management of periph- grafts do well. However, complications can ineral melting disorders may be clude active keratitis, postoperative melt, and
inflammation.
required when all else has failed
“The graft survival rate is
and an impending risk of perabout 50% [at] 5 years postforation may exist.
operatively after penetrating
Primary problems associkeratoplasty,” he said. “Lamelated with peripheral corneal
lar keratoplasty has slightly
diseases are disease progression in the form
better outcomes.”
of progressive corneal thinning and corneal
Dr. Tan
Various approaches to tecperforation, as well as secondary infection, irtonic keratoplasty include using small-patch
regular astigmatism, and ectasia.
C- or banana-shaped grafts applied in the grafts, mushroom grafts, or onlay of anterior
peripheral cornea can help maintain the cor- lamellar grafts to correct peripheral corneal
disorders. A tuck-in lamellar keratoplasty can
neal integrity and contour.
“The principle of surgical management of be performed to treat peripheral ectasias.
these complications is halting disease progression medically or systemically (by treating inM at ch-a n d -pat ch
flammatory or infection causes), and surgically
gr afts
restoring corneal integrity and anatomy by tec- Dr. Tan described his approach as “match-andtonic reconstruction of the peripheral cornea,” patch peripheral grafts” that are C-shaped to
said Donald Tan, FRCSE, FRCSG, FRCOphth.
avoid the central cornea.
Adjunctive procedures are gluing procedures,
“The idea is to have banana-shaped grafts
transplantation of amniotic membrane, and that are essentially anterior lamellar patch
conjunctival resection.
grafts shaped to restore integrity of the peA minimalist approach is suggested in these ripheral melting area,” he said. “The advancases, said Dr. Tan, the Arthur
tages are prevention of endoLim Professor of Ophthalmology
thelial rejection and minimiEndowed Chair, Duke-National
zation of intraocular surgery
Peripheral melting
University of Singapore Graduate
and complications, as well as
disorders require
Medical School, and professor
maintenance of the spherical
surgical intervention
of ophthalmology, Yong Loo Lin
corneal shape.”
when all else has
School of Medicine, National
In addition, the procedure
failed and there
University of Singapore.
can be performed in the presis an impending
An anterior lamellar patch
ence of a small- or moderaterisk of perforation.
graft may be the best choice if
sized perforation, he explained.
A peripheral C- or
the endothelium is not affected.
This provides tectonic reconbanana-shaped
“This will avoid involving
struction of the peripheral corgraft can restore
the unaffected central cornea,”
neal anatomy without replactectonic integrity
Dr. Tan said.
ing the central cornea.
while maintaining a
“The goal in these cases is to
“The crescentric-shaped graft
reasonable corneal
preserve or restore visual funcalso respects the central corcontour to preserve
tion,” he said. “To do so, toponeal shape,” he said. “The suvision.
graphic changes and irregular
tures can be tightened and with
astigmatism must also be adsubsequent suture removal the
dressed over the long term.”
astigmatism can be reduced.
Though not much information is in the lit- In addition, the procedure may be repeatable.”
erature concerning tectonic keratoplasty, it
Dr. Tan reported the outcomes in 34 cases
Singapore ::
S
Take-Home
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lamEllar kEratOplasty
VIDEO C- or banana-shaped grafts
applied in the peripheral cornea can help
maintain the corneal integrity and contour.
go to http://bit.ly/1L0EWB4
(Video courtesy of Donald Tan, FRCSE, FRCSG,
FRCOphth)
of Mooren’s ulceration in 22 patients treated
with “banana” grafts who were followed for
about 5 years.
“About 50% of these patients required a second graft because of disease recurrence,” he
said. “Tectonic success was about 88%.”
about the surgical
procedur e
The procedure to create the recipient bed is
not highly difficult, but requires careful attention to detail to reconstruct corneal anatomy,
Dr. Tan noted. He described the technique in
a patient with a banana-shaped corneal melt.
Marking trephines are used to regularize the
slightly irregular area of corneal melting. A
central trephine is used to mark the central radius. A 13- or 14-mm trephine is used to mark
the peripheral radius.
Smaller-diameter dermatological trephines
are useful to mark the edges of the banana
shape, he noted.
Dr. Tan cautioned against causing a perforation. Free-hand lamellar dissection is performed using a crescent blade.
The donor procedure is performed using a
14-mm orbital glass implant that is covered
with cloth. The implant is placed in a punch
Continues on page 12 : Peripheral cornea
ES557243_OT020115_009.pgs 01.22.2015 01:57
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10
surgery
How presence of certain OVDs may
infuence IOL power calculations
Some ophthalmic viscosurgical devices may alter aberrometry, prevent wound hydration need
by lynda charters; Reviewed by Samuel Masket, MD
LoS angeL eS ::
Though use of aberromeTry
OVD
intraoperatively increases the accuracy of IOL
power calculations, the presence of an ophthalmic viscosurgical device (OVD) can negate the
need for wound stromal hydration, and may
alter the optical results provided by aberrometry, according to Samuel Masket, MD.
“The metric by which patients measure ophthalmologists is often by the uncorrected
visual acuity after surgery,”
said Dr. Masket, clinical professor, David Geffen School of
Medicine, University of California at Los Angeles. “CataDr. Masket
ract surgeons do not achieve
the same visual outcomes as LASIK surgeons,
nevertheless, that is how [they] are judged.”
To reach the high bar set by patients, aberrometry is being used intraoperatively, because
the instrument provides the aphakic refraction.
The position and thickness of the natural
lens do not come into play, and the anterior
and posterior corneal disparities are eliminated, he added.
An intraoperative aberrometer (ORA System,
WaveTec/Alcon Laboratories) uses a modified
version of the vergence formula and a proprietary algorithm for determining the effective lens position.
IOL BSS
IOL OVD
MAE BSS
MAE OVD
P Value
Provisc
19.94
19.92
0.33
+/–0.31
0.37
+/–0.33
NS
DiscoVisc
19.64
19.02
0.47
+/–0.42
0.88
+/–0.49
p<0.001*
Healon
19.54
19.43
0.40
+/–0.31
0.48
+/–0.32
NS
Healon GV
18.21
18.08
0.45
+/–0.36
0.53
+/–0.44
NS*
Amvisc
19.33
19.30
0.31
+/–.30
0.31
+/–0.31
NS
Amvisc Plus
19.68
19.20
0.29
+/–0.28
0.50
+/–0.36
p<0.026*
To answer the concern about whether the OVD alters the aberrometry readings, in the current study,
investigators evaluated 120 eyes in which 6 OVD agents were used (20 eyes in each group). The OVDs
included were ProVisc and DisCoVisc (Alcon), Healon and Healon GV (Abbott Medical Optics), and Amvisc
and Amvisc Plus (Bausch + Lomb). Standard aberrometry readings were done after eyes were flled with
balanced saline solution (BSS)—which then was replaced with an OVD—and the aberrometry reading was
repeated. The IOL power was selected from the BSS reading and manifest refractions were performed from
2 to 3 weeks postoperatively. Data were analyzed to determine a difference in the suggested IOL power
between the BSS and OVD readings. “In every case, the mean IOL suggested power was lower with OVD
than with BSS,” Dr. Masket said. “The mean absolute errors were lower with the BSS than with the OVD. The
fndings were statistically signifcant (p < 0.001 and p < 0.026, respectively) with DisCoVisc and Amvisc
Plus, which respectively induced ±0.49 and ±0.36 D differences in the IOL power. (Source: Samuel Masket, MD)
were within 0.5 D of the spherical component
of the refractive outcome,” he said.
To achieve such a result, Dr. Masket and
his colleagues followed a strict
protocol in the study—the important factors of which were
The presence
removal of the OVD with cortesting the dev ice
of an ophthalmic
tical cleanup, careful stromal
Dr. Masket and colleagues previscosurgical
hydration, IOP set at physiologic
viously tested 131 cases of 200
device may alter
levels, intraoperative measureconsecutive cases in which the
the optical results
ment with a tonometer, avoiddevice was used.
of intraoperative
ance of speculum and other
The 131 cases had only one
aberrometry, but
external forces on the globe,
type of IOL (SN series IOL,
prevent the need
and obtainment of aberromAlcon) implanted, had no prior
for wound stromal
etry readings at least two to
corneal or refractive surgery,
hydration.
three times intraoperatively
and had no comorbidities.
for consistency, with special
Of the 131 eyes, investigafocus on the axis and magnitors found that they changed
the IOL power in 56 (42.7%) eyes based on the tude of cylinder.
However, investigators questioned the need
device and in 75 eyes, the IOL powers were
to remove the OVD before aberrometry was
not changed.
“Ultimately, greater than 90% of the eyes performed.
Take-Home
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ov ds a nd low er iol pow er
“If the chamber is filled with OVD, no stromal hydration is needed to maintain a leakfree system,” Dr. Masket said. “Concern is that
aggressive hydration of the incision alters the
corneal curvature.”
To answer the concern about whether the
OVD alters the aberrometry readings, in the
current study, investigators evaluated 120 eyes
in which 6 OVD agents were used (20 eyes in
each group). The OVDs included were ProVisc
and DisCoVisc (Alcon), Healon and Healon GV
(Abbott Medical Optics), and Amvisc and Amvisc Plus (Bausch + Lomb).
Standard aberrometry readings were done
after eyes were filled with balanced saline solution (BSS)—which then was replaced with
an OVD—and the aberrometry reading was
repeated.
The IOL power was selected from the BSS
reading and manifest refractions were performed
Continues on page 12 : IOL power
ES557242_OT020115_010.pgs 01.22.2015 01:57
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NOT A HOLE.
INFINITE
POSSIBILITIES.
Micro Invasive Glaucoma Surgery (MIGS) procedures bring infinite possibility to
the treatment of early stage open-angle glaucoma. Now FDA-approved, the iStent®
Trabecular Micro-Bypass stent is indicated for use in conjunction with cataract
surgery for the reduction of intraocular pressure in adult patients with mild-tomoderate open-angle glaucoma currently treated with ocular hypotensive medication.
To learn more contact Glaukos at 800.452.8567 or visit www.glaukos.com.
INDICATION FOR USE. The iStent® Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is indicated for use in conjunction with cataract surgery for the reduction of intraocular
pressure (IOP) in adult patients with mild-to-moderate open-angle glaucoma currently treated with ocular hypotensive medication. CONTRAINDICATIONS. The iStent® is contraindicated
in eyes with primary or secondary angle closure glaucoma, including neovascular glaucoma, as well as in patients with retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or
any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude PAS, rubeosis, and other angle
abnormalities or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard. The iStent® is MR-Conditional
meaning that the device is safe for use in a specified MR environment under specified conditions, please see label for details. PRECAUTIONS. The surgeon should monitor the patient
postoperatively for proper maintenance of intraocular pressure. The safety and effectiveness of the iStent® has not been established as an alternative to the primary treatment of glaucoma
with medications, in children, in eyes with significant prior trauma, chronic inflammation, or an abnormal anterior segment, in pseudophakic patients with glaucoma, in patients with
pseudoexfoliative glaucoma, pigmentary, and uveitic glaucoma, in patients with unmedicated IOP less than 22 mmHg or greater than 36 mmHg after “washout” of medications, or in
patients with prior glaucoma surgery of any type including argon laser trabeculoplasty, for implantation of more than a single stent, after complications during cataract surgery, and when
implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract. ADVERSE EVENTS. The most common post-operative adverse events
reported in the randomized pivotal trial included early post-operative corneal edema (8%), BCVA loss of ≥ 1 line at or after the 3 month visit (7%), posterior capsular opacification (6%),
stent obstruction (4%) early post-operative anterior chamber cells (3%), and early post-operative corneal abrasion (3%). Please refer to Directions for Use for additional adverse event
information. CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please reference the Directions for Use labeling for a complete list of contraindications,
warnings, precautions, and adverse events. ©2015 Glaukos Corporation. Glaukos and iStent are registered trademarks of Glaukos Corporation.
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ES557983_OT020115_011_FP.pgs 01.23.2015 00:40
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12
surgery
iol power
( Continued from page 10 )
from 2 to 3 weeks postoperatively. Data were
analyzed to determine a difference in the suggested IOL power between the BSS and OVD
readings.
< 0.001 and p < 0.026, respectively) with
DisCoVisc and Amvisc Plus, which respectively induced ±0.49 and ±0.36 D differences
in the IOL power.
“The findings indicate that aberrometry readings performed with certain OVDs in the eye
will provide a lower IOL power,” Dr. Masket
explained. “The path of light is slowed when
it goes through the OVD [due to] the index of
‘The fndings indicate that aberrometry
readings performed with certain OVDs
in the eye will provide a lower IOL power.’
ProVisc, and Amvisc have a low-molecular
weight and low concentration and therefore,
are insignificantly different, he continued.
“The surgeon, therefore, can be comfortable using those agents instead of BSS,” Dr.
Masket said.
suMMarizing
findings
Study findings indicate intraoperative aberrometry adds to the accuracy of IOL power
calculations, according to Dr. Masket. The
presence of an OVD can alter aberrometry
results, but they prevent the need for hydration of the wound.
Surgeons who use the lower molecular weight
hyaluraonic-based OVDs can be confident.
An alternate to an OVD may be an incisional
sealant, Dr. Masket concluded. ■
— Samuel Masket, MD
“In every case, the mean IOL suggested
power was lower with OVD than with BSS,”
Dr. Masket said. “The mean absolute errors
were lower with the BSS than with the OVD.
The findings were statistically significant (p
refraction. Because the path of light is slowed,
the aberrometer assumes that the eye is longer and suggests an IOL with a lower power.”
Though the presence of an OVD may affect
the readings obtained with the device, Healon,
peripHeral cornea
ectasia can be prevented by using a smallersized donor tissue that is sutured tightly with
interrupted 9/0 nylon sutures, which splints
the cornea, and negates the ectasia.”
In this situation, the compressive lamellar donor graft is narrower than the recipient
bed, according to Dr. Tan.
“We can effectively reduce a great deal of
astigmatism and ectasia using this type of graft
and tight suturing,” he said. “The intended
overcorrection can subsequently be reversed
with careful sequential suture removal several months later.”
and sutured, which facilitates any desired tissue shape, he explained.
The corneal tissue is matched to the bed and
sutured in place. A lamellar or full-thickness
dissection can be performed using the same
marking trephines used for the recipient bed.
ot h er pat ie n t
consider ations
One factor to consider is whether a patient has
ectasia. Cases of classic Mooren’s syndrome,
Dr. Tan pointed out, may not have ectasia.
However, other peripheral noninflammatory disorders, such as pellucid marginal degeneration, have substantial thinning, protrusion, and bulging.
“In the thin periphery, the same C-shaped lamellar graft can be applied,” he said. “However,
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black
ongoing case
Dr. Tan highlighted the case of a 76-year-old
woman with rheumatoid arthritis.
In 2006, the left eye of the patient had a corneal melt adjacent to a pterygium, which was
excised and a conjunctival graft put into place.
In 2008, the corneal again melted and the
rheumatoid arthritis was confirmed.
The patient was treated for years with a
systemic medication. A second lamellar patch
Samuel maSkeT, mD
e: [email protected]
Dr. Masket is a consultant to WaveTec and has received research funding from the
company. The co-authors of the study were Nicole R. Fram, MD, Los Angeles and Jack
Holladay, MD, Houston. Dr. Masket won the best paper of session for this presentation
at the 2014 meeting of the American Academy of Ophthalmology.
procedure was performed, demonstrating the
repeatability of the surgery.
Three years later, another melt occurred
away from the graft with tapering of the systemic medications.
In 2011, another melt occurred and a fourth
graft was applied.
In 2014, an intrastromal crystalline opacity developed between the four grafts, which
was suspected to be a fungal infection and
progressed to another melt.
Ultimately, a central deep anterior lamellar
keratoplasty was performed that encompassed
all the previous grafts.
In this ongoing case, the patient currently
has 20/200 vision. ■
DonalD Tan, FrcSe, FrcSG, FrcopHTH
Dr. Tan has no fnancial interest in the subject matter
ES557241_OT020115_012.pgs 01.22.2015 01:56
ADV
FebruAry 1, 2015 :: Ophthalmology Times
13
drug therapy
Subretinal fluid protective
of vision, CATT study finds
A surprise fnding indicates
some retained fuid may be
benefcial, researchers say
By Michelle dalton, elS;
Reviewed by Sumit Sharma, MD
ADD SIMBRINZA® Suspension to a PGA for Even Lower IOP1*
Durham, NC ::
yes with foveal intraretinal fluid,
abnormally thin retinas, and
those developing a geographic
atrophy or scar had the worst
visual acuity in an assessment of
morphologic features associated
with visual acuity in the second
year of the Comparison of Age-related Macular
Degeneration (AMD) Treatment Trials (CATT).
The purpose of the study was to look at
“which factors on optical coherence tomography (OCT) are predictive of visual acuity
changes,” said Sumit Sharma, MD, clinical associate, Department of Ophthalmology, Duke
Eye Center, Durham, NC.
“That’s the main goal,” Dr. Sharma said. “We
expected certain things—that having fluid gives
patients worse vision, [or] that having a scar or
geographic atrophy gives patients worse vision.”
What the group did not expect to find, however, was that subretinal fluid under the fovea
was actually protective of vision.
Several theories exist about the reasons why
subretinal fluid in that location seems to be
protective, “but some think it may be because
we’re drying out those patients too much and
it’s leaving them more atrophied,” Dr. Sharma
said. “Even when we controlled and accounted
for that with multivariate regression models,
we still found subretinal fluid is protective.”
E
St u dy deta i l S
Eligibility criteria required evidence on fluorescein angiography and OCT of choroidal
neovascularization (CNV) secondary to AMD
and visual acuity between 20/25 and 20/320
in the study eye, the researchers said.
Treatment was assigned randomly to either
ranibizumab (Lucentis, Genentech) or bevacizumab (Avastin, Genentech) and to three difContinues on page 14: Subretinal fuid
magenta
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black
SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension)
1%/0.2% is a fixed combination indicated in the reduction of elevated
intraocular pressure (IOP) in patients with open-angle glaucoma or
ocular hypertension.
Dosage and Administration
The recommended dose is one drop of SIMBRINZA® Suspension in the
affected eye(s) three times daily. Shake well before use. SIMBRINZA®
Suspension may be used concomitantly with other topical ophthalmic drug
products to lower intraocular pressure. If more than one topical ophthalmic
drug is being used, the drugs should be administered at least five (5)
minutes apart.
IMPORTANT SAFETY INFORMATION
Contraindications
SIMBRINZA® Suspension is contraindicated in patients who are hypersensitive
to any component of this product and neonates and infants under the age of
2 years.
Warnings and Precautions
Sulfonamide Hypersensitivity Reactions—Brinzolamide is a sulfonamide,
and although administered topically, is absorbed systemically. Sulfonamide
attributable adverse reactions may occur. Fatalities have occurred due
to severe reactions to sulfonamides. Sensitization may recur when a
sulfonamide is readministered irrespective of the route of administration.
If signs of serious reactions or hypersensitivity occur, discontinue the use
of this preparation.
Corneal Endothelium—There is an increased potential for developing
corneal edema in patients with low endothelial cell counts.
Severe Hepatic or Renal Impairment (CrCl <30 mL/min)—SIMBRINZA®
Suspension has not been specifically studied in these patients and is
not recommended.
Contact Lens Wear—The preservative in SIMBRINZA® Suspension,
benzalkonium chloride, may be absorbed by soft contact lenses. Contact
lenses should be removed during instillation of SIMBRINZA® Suspension
but may be reinserted 15 minutes after instillation.
Severe Cardiovascular Disease—Brimonidine tartrate, a component of
SIMBRINZA® Suspension, had a less than 5% mean decrease in blood
pressure 2 hours after dosing in clinical studies; caution should be
exercised in treating patients with severe cardiovascular disease.
Adverse Reactions
SIMBRINZA® Suspension
In two clinical trials of 3 months’ duration with SIMBRINZA® Suspension,
the most frequent reactions associated with its use occurring in
approximately 3-5% of patients in descending order of incidence
included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth,
and eye allergy. Adverse reaction rates with SIMBRINZA® Suspension
were comparable to those of the individual components. Treatment
discontinuation, mainly due to adverse reactions, was reported in 11% of
SIMBRINZA® Suspension patients.
Prescribe SIMBRINZA® Suspension as
adjunctive therapy to a PGA for
appropriate patients
SIMBRINZA® Suspension should be taken at least
five (5) minutes apart from other topical ophthalmic
drugs
Up to
7.1 mm Hg
additional IOP
reduction from
baseline when
added to a PGA1
5.6† mm Hg
additional mean
diurnal IOP
lowering observed
from baseline when
added to a PGA1
Treatment Arm
PGA + SIMBRINZA®
Suspension (N=88)
PGA + Vehicle
(N=94)
Baseline§
Week 6
Baseline§
Week 6
IOP Daily Time Points (mm Hg)‡
8 AM
10 AM
3 PM
24.5
22.9
21.7
19.4
15.8
17.2
24.3
22.6
21.3
21.5
20.3
20.0
5 PM
21.6
15.6
21.2
20.1
Differences (mm Hg) and P-values at Week 6 time points between treatment groups were: -2.14,
P=0.0002; -4.56, P<0.0001; - 2.84, P<0.0001; -4.42, P<0.0001.
§
Baseline (PGA Monotherapy)
‡
Mean Diurnal IOP (mm Hg)||
Treatment Arm
PGA + SIMBRINZA® Suspension (N=88)
PGA + Vehicle (N=94)
Baseline¶
Week 6
Baseline¶
Week 6
22.7
17.1
22.4
20.5
Differences (mm Hg) and P-values at Week 6 between treatment groups were -3.44, P<0.0001.
Baseline (PGA Monotherapy)
||
¶
Study Design: A prospective, randomized, multicenter, double-blind, parallel-group
study of 189 patients with open-angle glaucoma and/or ocular hypertension receiving
treatment with a PGA. PGA treatment consisted of either travoprost, latanoprost,
or bimatoprost. Patients in the study were randomized to adjunctive treatment with
SIMBRINZA® Suspension (N=88) or vehicle (N=94). The primary efficacy endpoint was
mean diurnal IOP (IOP averaged over all daily time points) at Week 6 between treatment
groups. Key secondary endpoints included IOP at Week 6 for each daily time point
(8 AM, 10 AM, 3 PM, and 5 PM) and mean diurnal IOP change from baseline to Week 6
between treatment groups.1
*PGA study-group treatment consisted of either travoprost, latanoprost, or bimatoprost.
†
95% Confidence Interval: -6.23 to -5.06.
Learn more at myalcon.com/simbrinza
For additional information about SIMBRINZA® Suspension, please see
Brief Summary of full Prescribing Information on adjacent page.
Reference: 1. Data on file, 2014
© 2014 Novartis 10/14 SMB14121JAD
ES556559_OT020115_013.pgs 01.21.2015 02:48
ADV
14
drug therapy
subretinal fluid
ferent dosing regimens over a 2-year period. A
linear regression model was used to provide
BRIEF SUMMARY OF PRESCRIBING INFORMATION
SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic
suspension) 1%/0.2% is a fixed combination of a carbonic
anhydrase inhibitor and an alpha 2 adrenergic receptor
agonist indicated for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or
DOSAGE AND ADMINISTRATION
The recommended dose is one drop of SIMBRINZA®
Suspension in the affected eye(s) three times daily. Shake
well before use. SIMBRINZA® Suspension may be used
concomitantly with other topical ophthalmic drug products
to lower intraocular pressure.
If more than one topical ophthalmic drug is being used, the
drugs should be administered at least five (5) minutes apart.
DOSAGE FORMS AND STRENGTHS
Suspension containing 10 mg/mL brinzolamide and 2 mg/
mL brimonidine tartrate.
CONTRAINDICATIONS
Hypersensitivity - SIMBRINZA® Suspension is contraindicated in patients who are hypersensitive to any component
of this product.
Neonates and Infants (under the age of 2 years) SIMBRINZA® Suspension is contraindicated in neonates and
infants (under the age of 2 years) see Use in Specific
Populations
Sulfonamide Hypersensitivity Reactions - SIMBRINZA®
Suspension contains brinzolamide, a sulfonamide, and
although administered topically is absorbed systemically.
Therefore, the same types of adverse reactions that
are attributable to sulfonamides may occur with topical
administration of SIMBRINZA® Suspension. Fatalities have
occurred due to severe reactions to sulfonamides including
Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia,
and other blood dyscrasias. Sensitization may recur when a
sulfonamide is re-administered irrespective of the route of
administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation [see
Patient Counseling Information]
Corneal Endothelium - Carbonic anhydrase activity has
been observed in both the cytoplasm and around the
plasma membranes of the corneal endothelium. There is
an increased potential for developing corneal edema in
patients with low endothelial cell counts. Caution should
be used when prescribing SIMBRINZA® Suspension to this
group of patients.
Severe Renal Impairment - SIMBRINZA® Suspension
has not
been specifically studied in patients with severe renal
impairment (CrCl < 30 mL/min). Since brinzolamide and
its metabolite are excreted predominantly by the kidney,
SIMBRINZA® Suspension is
not recommended in such patients.
Acute Angle-Closure Glaucoma - The management
of patients with acute angle-closure glaucoma requires
therapeutic interventions in addition to ocular hypotensive
agents. SIMBRINZA® Suspension has not been studied in
patients with acute angle-closure glaucoma.
Contact Lens Wear - The preservative in SIMBRINZA®
Suspension, benzalkonium chloride, may be absorbed by
soft contact lenses. Contact lenses should be removed
during instillation of SIMBRINZA® Suspension but may
be reinserted 15 minutes after instillation [see Patient
Counseling Information].
Severe Cardiovascular Disease - Brimonidine tartrate,
a component of SIMBRINZA® Suspension, has a less than
5% mean decrease in blood pressure 2 hours after dosing
in clinical studies; caution should be exercised in treating
patients with severe cardiovascular disease.
Severe Hepatic Impairment - Because brimonidine
tartrate, a component of SIMBRINZA® Suspension, has not
been studied in patients with hepatic impairment, caution
should be exercised in such patients.
Potentiation of Vascular Insufficiency - Brimonidine
tartrate, a component of SIMBRINZA® Suspension, may potentiate syndromes associated with vascular insufficiency.
SIMBRINZA® Suspension should be used with caution in
patients with depression, cerebral or coronary insufficiency,
Raynaud’s phenomenon, orthostatic hypotension, or
thromboangiitis obliterans.
Contamination of Topical Ophthalmic Products After
Use - There have been reports of bacterial keratitis
associated with the use of multiple-dose containers of
topical ophthalmic products. These containers have been
inadvertently contaminated by patients who, in most
cases, had a concurrent corneal disease or a disruption of
the ocular epithelial surface [see Patient Counseling
Information].
ADVERSE REACTIONS
Clinical Studies Experience - Because clinical studies
are conducted under widely varying conditions, adverse
reaction rates observed in the clinical studies of a drug
cannot be directly compared to the rates in the clinical
studies of another drug and may not reflect the rates
observed in practice.
SIMBRINZA® Suspension - In two clinical trials of 3 months
duration 435 patients were treated with SIMBRINZA®
Suspension, and 915 were treated with the two individual
components. The most frequently reported adverse reactions in patients treated with SIMBRINZA® Suspension occurring in approximately 3 to 5% of patients in descending
order of incidence were blurred vision, eye irritation,
dysgeusia (bad taste), dry mouth, and eye allergy. Rates of
adverse reactions reported with the individual components
were comparable. Treatment discontinuation, mainly due
to adverse reactions, was reported in 11% of SIMBRINZA®
Suspension patients.
Other adverse reactions that have been reported with the
individual components during clinical trials are listed below.
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estimates of mean visual acuity adjusted for
all significant morphologic features.
Among 1,185 CATT participants, 993 (84%)
had fluid on OCT at baseline and 2-year follow up data. At 2 years, the mean visual acuity (letters) of eyes varied substantially by the
type of subfoveal pathology on FP: 70.6 for no
Brinzolamide 1% - In clinical studies of brinzolamide
ophthalmic suspension 1%, the most frequently reported
adverse reactions reported in 5 to 10% of patients were
blurred vision and bitter, sour or unusual taste. Adverse
reactions occurring in 1 to 5% of patients were blepharitis,
dermatitis, dry eye, foreign body sensation, headache,
hyperemia, ocular discharge, ocular discomfort, ocular
keratitis, ocular pain, ocular pruritus and rhinitis.
The following adverse reactions were reported at an
incidence below 1%: allergic reactions, alopecia, chest
pain, conjunctivitis, diarrhea, diplopia, dizziness, dry mouth,
dyspnea, dyspepsia, eye fatigue, hypertonia, keratoconjunctivitis, keratopathy, kidney pain, lid margin crusting or sticky
sensation, nausea, pharyngitis, tearing and urticaria.
Brimonidine Tartrate 0.2% - In clinical studies of
brimonidine tartrate 0.2%, adverse reactions occurring in
approximately 10 to 30% of the subjects, in descending
order of incidence, included oral dryness, ocular hyperemia,
burning and stinging, headache, blurring, foreign body
sensation, fatigue/drowsiness, conjunctival follicles, ocular
allergic reactions, and ocular pruritus.
Reactions occurring in approximately 3 to 9% of the
subjects, in descending order included corneal staining/
erosion, photophobia, eyelid erythema, ocular ache/pain,
ocular dryness, tearing, upper respiratory symptoms, eyelid
edema, conjunctival edema, dizziness, blepharitis, ocular
irritation, gastrointestinal symptoms, asthenia, conjunctival
blanching, abnormal vision and muscular pain.
The following adverse reactions were reported in less than
3% of the patients: lid crusting, conjunctival hemorrhage,
abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal
dryness and syncope.
Postmarketing Experience - The following reactions have
been identified during postmarketing use of brimonidine
tartrate ophthalmic solutions in clinical practice. Because
they are reported voluntarily from a population of unknown
size, estimates of frequency cannot be made. The reactions,
which have been chosen for inclusion due to either their
seriousness, frequency of reporting, possible causal
connection to brimonidine tartrate ophthalmic solutions,
or a combination of these factors, include: bradycardia,
hypersensitivity, iritis, keratoconjunctivitis sicca, miosis,
nausea, skin reactions (including erythema, eyelid pruritus,
rash, and vasodilation), and tachycardia.
Apnea, bradycardia, coma, hypotension, hypothermia,
hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine
tartrate ophthalmic solutions [see Contraindications].
DRUG INTERACTIONS
Oral Carbonic Anhydrase Inhibitors - There is a potential
for an additive effect on the known systemic effects of
carbonic anhydrase inhibition in patients receiving an oral
carbonic anhydrase inhibitor and brinzolamide ophthalmic
suspension 1%, a component of SIMBRINZA® Suspension.
The concomitant administration of SIMBRINZA® Suspension
and oral carbonic anhydrase inhibitors is not recommended.
High-Dose Salicylate Therapy - Carbonic anhydrase inhibitors may produce acid-base and electrolyte alterations.
These alterations were not reported in the clinical trials
with brinzolamide ophthalmic suspension 1%. However, in
patients treated with oral carbonic anhydrase inhibitors,
rare instances of acid-base alterations have occurred with
high-dose salicylate therapy. Therefore, the potential for
such drug interactions should be considered in patients
receiving SIMBRINZA® Suspension.
CNS Depressants - Although specific drug interaction studies have not been conducted with SIMBRINZA® Suspension,
the possibility of an additive or potentiating effect with CNS
depressants (alcohol, opiates, barbiturates, sedatives, or
anesthetics) should be considered.
Antihypertensives/Cardiac Glycosides - Because brimonidine tartrate, a component of SIMBRINZA® Suspension,
may reduce blood pressure, caution in using drugs such
as antihypertensives and/or cardiac glycosides with
SIMBRINZA® Suspension is advised.
Tricyclic Antidepressants - Tricyclic antidepressants have
been reported to blunt the hypotensive effect of systemic
clonidine. It is not known whether the concurrent use of
these agents with SIMBRINZA® Suspension in humans can
lead to resulting interference with the IOP lowering effect.
Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of
circulating amines.
Monoamine Oxidase Inhibitors - Monoamine oxidase
(MAO) inhibitors may theoretically interfere with the
metabolism of brimonidine tartrate and potentially result
in an increased systemic side-effect such as hypotension.
Caution is advised in patients taking MAO inhibitors which
can affect the metabolism and uptake of circulating amines.
Pregnancy - Pregnancy Category C: Developmental
toxicity studies with brinzolamide in rabbits at oral doses
of 1, 3, and 6 mg/kg/day (20, 60, and 120 times the
recommended human ophthalmic dose) produced maternal
toxicity at 6 mg/kg/day and a significant increase in the
number of fetal variations, such as accessory skull bones,
which was only slightly higher than the historic value at 1
and 6 mg/kg. In rats, statistically decreased body weights
of fetuses from dams receiving oral doses of 18 mg/kg/
day (180 times the recommended human ophthalmic dose)
during gestation were proportional to the reduced maternal
weight gain, with no statistically significant effects on organ
or tissue development. Increases in unossified sternebrae,
reduced ossification of the skull, and unossified hyoid
that occurred at 6 and 18 mg/kg were not statistically
significant. No treatment-related malformations were
seen. Following oral administration of 14C-brinzolamide to
pregnant rats, radioactivity was found to cross the placenta
and was present in the fetal tissues and blood.
Developmental toxicity studies performed in rats with
oral doses of 0.66 mg brimonidine base/kg revealed no
evidence of harm to the fetus. Dosing at this level resulted
in a plasma drug concentration approximately 100 times
higher than that seen in humans at the recommended
human ophthalmic dose. In animal studies, brimonidine
crossed the placenta and entered into the fetal circulation
to a limited extent.
There are no adequate and well-controlled studies in
pregnant women. SIMBRINZA® Suspension should be used
during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Nursing Mothers - In a study of brinzolamide in lactating
rats, decreases in body weight gain in offspring at an oral
dose of 15 mg/kg/day (150 times the recommended human
ophthalmic dose) were observed during lactation. No other
effects were observed. However, following oral administration of 14C-brinzolamide to lactating rats, radioactivity was
found in milk at concentrations below those in the blood
and plasma. In animal studies, brimonidine was excreted
in breast milk.
It is not known whether brinzolamide and brimonidine
tartrate are excreted in human milk following topical ocular
administration. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in nursing infants from SIMBRINZA® (brinzolamide/
brimonidine tartrate ophthalmic suspension) 1%/0.2%, a
decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance
of the drug to the mother.
Pediatric Use - The individual component, brinzolamide,
has been studied in pediatric glaucoma patients 4 weeks
to 5 years of age. The individual component, brimonidine
tartrate, has been studied in pediatric patients 2 to 7 years
old. Somnolence (50-83%) and decreased alertness was
seen in patients 2 to 6 years old. SIMBRINZA® Suspension
is contraindicated in children under the age of 2 years [see
Contraindications].
Geriatric Use - No overall differences in safety or
effectiveness have been observed between elderly and
adult patients.
OVERDOSAGE
Although no human data are available, electrolyte
imbalance, development of an acidotic state, and possible
nervous system effects may occur following an oral overdose of brinzolamide. Serum electrolyte levels (particularly
potassium) and blood pH levels should be monitored.
Very limited information exists on accidental ingestion of
brimonidine in adults; the only adverse event reported to
date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children
receiving brimonidine as part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment
of an oral overdose includes supportive and symptomatic
therapy; a patent airway should be maintained.
Sulfonamide Reactions - Advise patients that if serious or
unusual ocular or systemic reactions or signs of hypersensitivity occur, they should discontinue the use of the product
and consult their physician.
Temporary Blurred Vision - Vision may be temporarily
blurred following dosing with SIMBRINZA® Suspension.
Care should be exercised in operating machinery or driving
a motor vehicle.
Effect on Ability to Drive and Use Machinery - As with
other drugs in this class, SIMBRINZA® Suspension may
cause fatigue and/or drowsiness in some patients. Caution
patients who engage in hazardous activities of the potential
for a decrease in mental alertness.
Avoiding Contamination of the Product - Instruct patients
that ocular solutions, if handled improperly or if the tip of
the dispensing container contacts the eye or surrounding
structures, can become contaminated by common bacteria
known to cause ocular infections. Serious damage to the
eye and subsequent loss of vision may result from using
contaminated solutions [see Warnings and Precautions ]. Always replace the cap after using. If solution
changes color or becomes cloudy, do not use. Do not use
the product after the expiration date marked on the bottle.
Intercurrent Ocular Conditions - Advise patients that if
they have ocular surgery or develop an intercurrent ocular
condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued
use of the present multidose container.
Concomitant Topical Ocular Therapy - If more than one
topical ophthalmic drug is being used, the drugs should be
administered at least five minutes apart.
Contact Lens Wear - The preservative in SIMBRINZA®
Suspension, benzalkonium chloride, may be absorbed by
soft contact lenses. Contact lenses should be removed
during instillation of SIMBRINZA® Suspension, but may be
reinserted 15 minutes after instillation.
©2013 Novartis
U.S. Patent No:
6,316,441
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
1-800-757-9195
[email protected]
pathology, 74.1 for fluid only, 73.3 for CNV or
pigment epithelial (RPE) detachment, 68.4 for
nongeographic atrophy, 62.9 for geographic atrophy, hemorrhage, RPE tear, or blocked fluorescence; and 62.9 for scar.
Eyes with subretinal fluid in the foveal center on OCT had better a mean visual acuity of
about 71 letters compared with 67 letters in eyes
without fluid (p = 0.006). Eyes with intraretinal fluid in the foveal center had worse mean
visual acuity (about 60 letters) than eyes without intraretinal fluid (70.9 letters; p < 0.0001).
“Developing a scar or geographic atrophy
is associated by far with the worst vision of
any type of pathology that patients can have
with AMD,” Dr. Sharma said.
At the 2014 meeting of the American Society
of Retinal Specialists, Susan Bressler, MD, suggested some scarring is being misidentified as
geographic atrophy, and that may help explain
why some patients don’t dry out.
“Dr. Bressler’s comments are on point,” Dr.
Sharma said. “People look at OCT and qualify
something as geographic atrophy, but without
having the fluorescein to confirm the diagnosis.”
Autofluorescence—which was not used during the CATT study—can more accurately differentiate between scarring and geographic
atrophy, Dr. Sharma said.
Mov i ng f orwa r d
Investigators are currently evaluating “what
the etiology or reason is for better vision with
subretinal fluid,” Dr. Sharma said. “We’re doing
additional analyses and going back and re-analyzing a lot of the data in the CATT study.”
Others have found similar things in the other
large AMD studies, including the U.K.’s Inhibition of VEGF in Age-related Choroidal Neovascularization (IVAN) study, Dr. Sharma said.
It’s almost counterintuitive that retained fluid
would be more protective than the complete
elimination of the fluid, but “we also don’t
want to treat until patients are so dry they’re
developing atrophy,” he said. ■
Reference
1. Sharma S, Toth CA, Daniel E, Grunwald JE, et al.
Macular morphology and visual acuity in the second
year of the Comparison of Age-related Macular
Degeneration Treatments Trials (CATT). Paper
presented at: Association for Research in Vision and
Ophthalmology, May 5, 2014; Orlando.
sumit sharma, md
This article was adapted from Dr. Sharma’s presentation during the 2014 meeting of
the Association for Research in Vision and Ophthalmology. Dr. Sharma does not have
any fnancial disclosures related to his comments.
© 2014 Novartis 10/14
SMB14121JAD
ES556562_OT020115_014.pgs 01.21.2015 02:48
ADV
1515
surgical and clinical management of
Special Report )
glaucoma
AdvAnces continue to progress for cAre, treAtment of pAtients with glAucomAtous eyes
Steps most likely to avoid failure, he said, are:
> careful trabeculectomy,
> meticulous technique,
> watertight closure of the limbus,
> control of scarring, and
> attentive management of postoperative
inflammation.
> Prevention is better than cure
> Intervene sooner rather than
later
> Identify the site of failure
> Plan the intervention
> Manage post-needling
infammation carefully
> Don’t fog a dead horse
(Image courtesy of Keith R. Martin, MD,
FRCOphth)
What to do When
blebs start to fail
Prompt intervention and careful planning can help
to provide successful outcomes for these patients
By nancy groves; Reviewed by Keith R. Martin, MD, FRCOphth
take-home
Bleb failure can
often be avoided
with well-managed
trabeculectomy and
effective postoperative
care.
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W
Cambridge, engl and ::
hen blebs start to fail,
ophthalmologists need
a systematic approach,
and the first principle is
that prevention is better
than cure for these situations.
In addition, intervention sooner rather than
later is also better for these patients, according
to Keith R. Martin, MD, FRCOphth, professor of
ophthalmology, University of Cambridge, Cambridge, England.
The first days and weeks following surgery
are a critical period, Dr. Martin said.
“During this time, adjustment or lasering
or removal of flap sutures can be effective,”
he said. “Bleb massage can be useful in some
of our patients, although it’s important to recognize that this is not a substitute for control
of the inflammation by other methods.
The next management principle is to identify the site of failure.
“If your bleb is flat, it’s likely that you have
either obstruction of the internal ostium, scarring of the flap, or a leak,” Dr. Martin said.
“Gonioscopy is key here in the assessment,
and it’s often neglected. With gonioscopy,
you can see directly if the internal ostium
is obstructed or if there’s no visible sclerostomy, in which case needling is very likely
to be unhelpful.”
planning the surgical
intervention
Once the site of failure has been found, intervention can be planned. While needling
can often be performed safely in an office
or clinic, it is worth considering whether it
would be preferable to use an operating room.
This may be a wise choice if it is likely that
the needle will be inserted underneath the
flap into the anterior chamber or if previous
needlings have been difficult or have failed,
Dr. Martin explained.
It is also necessary to plan the anti-scarring treatment. Options include mitomycin or
5-fluorouracil (5-FU), although there is evidence that anti-vascular endothelial growth
factor agents may be effective, he said.
5-FU is still widely used and may be combined with viscoelastic, which is useful for
separating the tissue planes both at the time
of needling and postoperatively. It also aids
slow release of the drug and helps reduce
corneal toxicity by limiting the efflux of 5-FU
after the needling.
“We’re also increasingly using topical mitomycin, and there’s good evidence that by
topical application we can reach therapeutic
concentrations at the level of Tenon’s capsule,
Continues on page 30 : Bleb failure
ES557673_OT020115_015.pgs 01.22.2015 20:26
ADV
16
Special Report )
Surgical and clinical management of
Glaucoma
How OCT became a Ôgame changer’
Dr. Schuman discusses his role in its development, future of patient care for glaucoma
Sight Lines By J.C. Noreika, MD, MBA
Editor’s Note:
Welcome to the
latest installment
of “Sight Lines,” a
feature in which
J.C. Noreika, MD,
MBA, an ophthalmologist in Medina, OH, disDr. Noreika
cusses trends in
ophthalmology, medicine, and health
care with key leaders in their fields. In
this issue, Dr. Noreika talks with Joel
Schuman, MD, chairman, Department of
Ophthalmology, University of Pittsburgh
Medical Center.
Dr. noreika: Dr. Schuman, you are
internationally recognized not only as
a glaucoma specialist but also for your
role in developing optical coherence
tomography (ocT), which was a game
changer in ophthalmology. can you tell
us how it came to be developed?
Dr. Schuman: OCT is a technology that almost wasn’t. It’s the result of teamwork between
engineers, scientists, clinician-scientists, and
physicists. It also is an example of why it is important to be aware of what is around you, especially in an innovation-rich environment.
I became involved through serendipity. I
was working in the laser lab at Mass Eye and
Ear during my fellowship. I wasn’t doing a
laser fellowship, but Carmen Puliafito, MD,
who ran the laser lab, was kind enough to let
me use the technologies however I wanted.
I was studying the gradient of resistance
flow from Schlemm’s canal through the
sclera. To do that without damaging the tissue with each slice, I was using an excimer
laser. The laser was a laboratory excimer laser
and it only coincidentally has to do with this
story because they were developing a technology in the room next door that would measure the thickness of the cornea. The technology was called Optical Coherence Domain
Reflectometry (OCDR). The idea was that you
need the feedback for refractive surgery. It oc-
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curred to me the technology might be able to
get to the retina, in which case we would be
able to measure the thickness of the retina in
glaucoma and macular disease. Bill Stinson,
MD, a retina specialist who was a pre-residency fellow with me in the lab, also was involved in these discussions.
We ended up going to MIT where Jim Fujimoto, an expert in high-speed laser physics and engineering, was developing OCDR.
I brought a bag of calf eyes and with David
Huang, who was an MD-PhD student working with Jim, we cut them in half and looked
at the back half underneath the OCDR beam
to see if there would be a signal. There was!
This told us it could be done. After that, a
lot of work by many people went into developing what we have today as OCT. And the
idea actually of OCT itself, of creating a tomogram, came from Dr. Huang. He said that
if we can do these A-scans, why not just
move the beam transversally and we could
do a B-scan, and then interpolate between
the points and create a tomogram.
ophthalmologytimes.com
PODCAST
LISTEN TO what Joel Schuman, MD, says about
the use of optical coherence tomography (OCT) to
diagnose and follow glaucoma with patients, as
well as what the future may bring for the specialty.
Dr. Schuman begins by describing the early
influences in his career that led to his current
post. For the complete audio interview with J.C.
Noreika, MD, MBA, go to http://bit.ly/1uxXwlQ
Dr. noreika: how do you use ocT in
your practice?
Dr. Schuman: The early iterations of OCT
were most useful in terms of ruling out glaucoma as opposed to identifying people who
do have it. I still think that is an important
use of OCT technology. The second key role
for OCT today is in identifying people who
have parametric glaucoma, and identifying
the areas of abnormality and degree of damage to the retinal nerve fiber layer (RNFL).
The third use is to help guide treatment.
Being able to assess if there has been a statistically significant change in RNFL thickness
is extremely helpful.
One of the keys is knowing when OCT is
helpful and when it may be giving a false
sense of confidence. . . . If a patient has an
abnormal OCT reading but normal visual
field and normal pressures, we are very suspicious about glaucoma. If the abnormality is
consistent with the location and pattern that
I would expect in glaucoma, if it is an arcuate
abnormality that is emanating from the supra-temporal or infra-temporal portion of the
nerve, that helps discriminate between a nonglaucomatous abnormality and glaucoma.
You can tell if the abnormality in the
RNFL is glaucomatous by looking at the
macula and the ganglion cell inner plexiform
layer or the ganglion cell complex. Very early
on in the disease course, the two may not
correspond, but before there is a visual field
defect, you should be able to find correspondence between the nerve fiber layer measurement and the macular measurement.
That is an internal check I use all the time.
Dr. noreika: if this internal check
is positive, do you expect to see
something on perimetry?
Continues on page 18 : Sight Lines
ES557850_OT020115_016.pgs 01.22.2015 22:25
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ES557967_OT020115_017_FP.pgs 01.23.2015 00:39
ADV
18
Special Report )
Sight LineS
Dr. Schuman: No. Early in the disease,
you will have abnormalities on OCT without
a field defect. We published a paper called
Glaucoma
the “Tipping Point” in 2012 and in the Shaffer Lecture I gave at the Academy in 2013,
I talked about longitudinal assessment of a
population and found a tipping point.
Before this tipping point, there is a poor
relationship between structure and function.
There will be a structural abnormality but
no corresponding functional loss and likely
PROLENSA® (bromfenac ophthalmic solution) 0.07%
Brief Summary
PROLENSA® (bromfenac ophthalmic solution) 0.07% is indicated for the
treatment of postoperative infammation and reduction of ocular pain in
patients who have undergone cataract surgery.
PROLENSA® ophthalmic solution following cataract surgery include:
anterior chamber infammation, foreign body sensation, eye pain,
photophobia and vision blurred. These reactions were reported in 3 to
8% of patients.
Pregnancy
Treatment of rats at oral doses up to 0.9 mg/kg/day (systemic
exposure 90 times the systemic exposure predicted from the
recommended human ophthalmic dose [RHOD] assuming the human
systemic concentration is at the limit of quantifcation) and rabbits
at oral doses up to 7.5 mg/kg/day (150 times the predicted human
systemic exposure) produced no treatment-related malformations in
reproduction studies. However, embryo-fetal lethality and maternal
toxicity were produced in rats and rabbits at 0.9 mg/kg/day and
7.5 mg/kg/day, respectively. In rats, bromfenac treatment caused
delayed parturition at 0.3 mg/kg/day (30 times the predicted human
CONTRAINDICATIONS
exposure), and caused dystocia, increased neonatal mortality and
None
reduced postnatal growth at 0.9 mg/kg/day.
There are no adequate and well-controlled studies in pregnant women.
Sulfte Allergic Reactions
Because animal reproduction studies are not always predictive of
Contains sodium sulfte, a sulfte that may cause allergic-type reactions
human response, this drug should be used during pregnancy only if
including anaphylactic symptoms and life-threatening or less severe
the potential beneft justifes the potential risk to the fetus.
asthmatic episodes in certain susceptible people. The overall prevalence
Because of the known effects of prostaglandin biosynthesisof sulfte sensitivity in the general population is unknown and probably
inhibiting drugs on the fetal cardiovascular system (closure of ductus
low. Sulfte sensitivity is seen more frequently in asthmatic than in nonarteriosus), the use of PROLENSA® ophthalmic solution during late
asthmatic people.
pregnancy should be avoided.
Slow or Delayed Healing
Nursing Mothers
All topical nonsteroidal anti-infammatory drugs (NSAIDs), including
Caution should be exercised when PROLENSA is administered to a
bromfenac, may slow or delay healing. Topical corticosteroids are also
nursing woman.
known to slow or delay healing. Concomitant use of topical NSAIDs and Pediatric Use
topical steroids may increase the potential for healing problems.
Safety and effcacy in pediatric patients below the age of 18 have not
Potential for Cross-Sensitivity
been established.
There is the potential for cross-sensitivity to acetylsalicylic acid,
Geriatric Use
phenylacetic acid derivatives, and other NSAIDs, including bromfenac.
There is no evidence that the effcacy or safety profles for
Therefore, caution should be used when treating individuals who have
PROLENSA differ in patients 70 years of age and older compared to
previously exhibited sensitivities to these drugs.
younger adult patients.
Increased Bleeding Time
With some NSAIDs, including bromfenac, there exists the potential for
Carcinogenesis, Mutagenesis and Impairment of Fertility
increased bleeding time due to interference with platelet aggregation.
Long-term carcinogenicity studies in rats and mice given oral
There have been reports that ocularly applied NSAIDs may cause
doses of bromfenac up to 0.6 mg/kg/day (systemic exposure 30
increased bleeding of ocular tissues (including hyphemas) in conjunction
times the systemic exposure predicted from the recommended
with ocular surgery.
®
human ophthalmic dose [RHOD] assuming the human systemic
It is recommended that PROLENSA ophthalmic solution be used with
concentration is at the limit of quantifcation) and 5 mg/kg/day (340
caution in patients with known bleeding tendencies or who are receiving
times the predicted human systemic exposure), respectively, revealed
other medications which may prolong bleeding time.
no signifcant increases in tumor incidence.
Keratitis and Corneal Reactions
Bromfenac did not show mutagenic potential in various mutagenicity
Use of topical NSAIDs may result in keratitis. In some susceptible
studies, including the reverse mutation, chromosomal aberration, and
patients, continued use of topical NSAIDs may result in epithelial
micronucleus tests.
breakdown, corneal thinning, corneal erosion, corneal ulceration or
Bromfenac did not impair fertility when administered orally to male
corneal perforation. These events may be sight threatening. Patients with
and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day,
evidence of corneal epithelial breakdown should immediately discontinue
respectively (systemic exposure 90 and 30 times the predicted human
use of topical NSAIDs, including bromfenac, and should be closely
exposure, respectively).
monitored for corneal health.
Post-marketing experience with topical NSAIDs suggests that patients
PATIENT
COUNSELING INFORMATION
with complicated ocular surgeries, corneal denervation, corneal epithelial
defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), Slowed or Delayed Healing
Advise
patients of the possibility that slow or delayed healing may
rheumatoid arthritis, or repeat ocular surgeries within a short period
occur while using NSAIDs.
of time may be at increased risk for corneal adverse events which may
become sight threatening. Topical NSAIDs should be used with caution Sterility of Dropper Tip
Advise patients to replace bottle cap after using and to not touch
in these patients.
dropper tip to any surface, as this may contaminate the contents.
Post-marketing experience with topical NSAIDs also suggests that use
Advise patients that a single bottle of PROLENSA® ophthalmic
more than 24 hours prior to surgery or use beyond 14 days post-surgery
solution, be used to treat only one eye.
may increase patient risk for the occurrence and severity of corneal
Concomitant Use of Contact Lenses
adverse events.
Advise patients to remove contact lenses prior to instillation of
Contact Lens Wear
PROLENSA. The preservative in PROLENSA, benzalkonium
PROLENSA should not be instilled while wearing contact lenses.
chloride, may be absorbed by soft contact lenses. Lenses may be
Remove contact lenses prior to instillation of PROLENSA. The
reinserted after 10 minutes following administration of PROLENSA.
preservative in PROLENSA, benzalkonium chloride may be absorbed by
Concomitant Topical Ocular Therapy
soft contact lenses. Lenses may be reinserted after 10 minutes following
If more than one topical ophthalmic medication is being used, the
administration of PROLENSA.
medicines should be administered at least 5 minutes apart
ADVERSE REACTIONS
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US/PRA/14/0024
Recommended Dosing
One drop of PROLENSA® ophthalmic solution should be applied to
the affected eye once daily beginning 1 day prior to cataract surgery,
continued on the day of surgery, and through the frst 14 days of the
postoperative period.
Use with Other Topical Ophthalmic Medications
PROLENSA ophthalmic solution may be administered in conjunction
with other topical ophthalmic medications such as alpha-agonists, betablockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Drops should be administered at least 5 minutes apart.
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no visual field defect. After the tipping point,
the relationship between structure and function becomes quite strong. A change in OCT
and the visual field is likely to occur around
the same time. Early in the disease, all you
can use is OCT in someone who has glaucoma damage but normal field and normal
pressures. OCT lets me have a high level of
certainty before I diagnose glaucoma.
I would consider a patient a glaucoma
suspect in the case that I just talked about,
in which there is an early abnormality in the
nerve fiber layer or macula. . . . If they are
progressing, if the location and pattern of
the damage is glaucomatous, even without a
field defect or an elevated pressure, I would
make the diagnosis and start treatment.
The tipping point is at about 75 µm as
measured with the Zeiss OCT Cirrus (with
other spectral-domain OCTs, the number is
slightly different). The 95% confidence interval is about 6 µm in either direction. I would
not expect a field defect in somebody who
has inner fiber layer thickness in the 80s.
As devices and algorithms improve, that
bottoming-out effect will occur at a lower
thickness value. But right now, if someone has
a mean nerve fiber layer thickness in the low
50s, it will seem to be stable even if the patient
is getting worse. That is when you need to go
by visual field and not get a false sense of confidence from a stable OCT reading.
Dr. noreika: So under 50 µm, there
is no point in continuing to use ocT?
You would really have to use perimetry
determine if there is progression?
Dr. Schuman: Right. When nerve fiber
layer thickness is greater than 75 to 80,
(again, these are Cirrus units), the visual
field is unlikely to be very helpful. If it is
thinner than about 55, the nerve fiber layers
are unlikely to be very helpful. On both extremes, the tissue that is not helpful is likely
to give you a false sense of security.
Dr. noreika: You have confirmed a very
important concept, which is that these
tests go hand in hand but we need to
know how to use them appropriately.
The biggest change i have made in my
practice due to using cirrus ocT is i do
not overtreat as much. When you can
verify the presence of a thick nerve fiber
layer, you feel more comfortable.
Dr. Schuman: Yes, the ability to be sure
a patient does not have disease was the
major benefit early on of OCT and still is a
huge benefit today. ■
ES557849_OT020115_018.pgs 01.22.2015 22:25
ADV
19
Special Report )
SurgicAl AND cliNicAl mANAgemeNT Of
Glaucoma
How electrophysiology plays role
in early detection of glaucoma
Technology identifed decreased visual function where visual felds did not, shows analysis
By Mark a. latina, Md, Special to Ophthalmology Times
BOS TON ::
SINCE THE CONCLUSION of the
Early Manifest Glaucoma Trial, ophthalmologists have known that the sooner glaucoma
is treated, the better the prognosis.1 Making a
definitive diagnosis is often difficult, however.
Glaucoma can occur without high IOP, without
visual field defects, and without thin corneas.
The only characteristics patients with glaucoma have in common are the soma of ganglion
cell loss. Detecting retinal nerve fiber layer
(RNFL) thinning and/or ganglion cell loss at
their earliest manifestation while the cells are
beginning to lose function can be difficult.
Historically, visual evoked potentials (VEP)
and electroretinography (ERG) tests have been
used in research to analyze the functional integrity of the neuro-visual pathway. Though
the information from these tests was always
valuable, the nature of the testing made it impractical to integrate into clinical practice.
VEP and ERG testing equipment used to be
bulky, expensive, and fragile, and the extensive
data generated required a neurophysiologist to
decipher the results. ERG tests required sensors to be placed directly on the patient’s eye
and remain there for 45 to 50 minutes, creating a long and invasive exam.
An office-based system (NOVA Testing System, Diopsys) represents an advance in electrophysiology that allows clinicians the ability to detect pathology they were unable to
see previously, thereby detecting disease early.
undeR sta ndinG V ep, eRG
Through sensors placed on the patient’s head,
pattern VEP tracks electrical activity generated at the retina all the way to the visual cortex. The amplitude of the signal indicates the
number of healthy retinal cells and the visual
system’s ability to discriminate between different-sized objects. The more difficulty the
patient has seeing the stimulus, the smaller
the response.
The latency of the signal is the time it takes
for the electrical signal to travel from the retina
to the cortex. By comparing this with population averages, clinicians can detect delays in a
Continues on page 20 : Early detection
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Treatment Plan
a
c
B
e
D
a Visual felds
Shows high false positives in left eye.
B Fundus photos
greater cup-to-disc ratio in left eye confrms HrT.
c HRt
Shows increased cup OS>OD with borderline retinal
nerve fber layer.
D Shows slight delay in latency in OS in low
contrast.
e electroretinography (eRG)
OD: Slightly reduced magnitude and irregular
waveform.
OS: magnitude greatly reduced compared with OD
and more regular waveform.
Based on borderline delay of low contrast OS in
the VeP and poor waveforms and values in contrast
Sensitivity Perg test, aggressive treatment was
recommended for OS, and to lower iOP for both eyes.
follow-up tests: VeP, Perg, HVf, and HrT yearly.
(Images courtesy of Mark A. Latina, MD)
ES557866_OT020115_019.pgs 01.22.2015 22:37
ADV
20
Special Report )
SurgicAl AND cliNicAl mANAgemeNT Of
earLy Detection
Glaucoma
‘Detection of failing retinal ganglion
cells before they are irretrievably
lost could open all new possibilities
for glaucoma therapy.’ — Mark A. Latina, MD
particular individual. In essence, the longer it
takes for the electrical response to be evoked,
the more likely an existence of disease involving demyelination of the optic nerve sheath.
VEP supports or rules out subjective field
loss, and the low-contrast stimuli can help
in the documentation of damage to the optic origin of abnormalities to the retina or optic
nerve and allow the detection of early mag- nerve for more timely treatment.
nocellular dysfunction, which may be useful
for early glaucoma detection.
applications
Pattern ERG also detects size and speed of Glaucoma is most often identified by changes
the electrical signal, but through the retinal in a visual field test, but structural changes
ganglion cell bodies rather than the optic nerve. can also be observed via optical coherence toThe magnitude of pattern ERG
mography of the optic nerve head
results decrease proportionately,
and RNFL.
more than perimetric sensitivity,
Recent studies have shown,
detecting early states of glaucoma
however, that this structural dambefore the onset of visual field
age is preceded by damage to the
An offce-based
defects and RNFL loss.2
retinal ganglion cells that causes
system (NOVA Testing
them to lose their autoregulatory
Diopsys has developed specialSystem, Diopsys)
ability. A recent study showed that
ized patient-friendly ERG sensors
represents an advance
pattern ERG signals were able to
that are placed on the lower eyelid
in electrophysiological
anticipate an equivalent loss of
to analyze the function of ganglion
technology that allows
RNFL as seen on OCT by a mean
cells via two advanced protocols.
clinicians the ability to
of 8 years.2
The first is concentric stimudetect pathology they
lus fields. A 24° circle is projected
A separate study conducted at
have been unable to
onto the retina and a waveform
the New York Eye and Ear Infirsee in the past, thereby
is generated. Subsequently, a 16°
mary found that the low-contrast
detecting disease early.
circle is projected and a waveform
VEP protocol was able to identify
of smaller magnitude is generated.
patients with structural abnormalThis test is sensitive to changes in
ities consistent with glaucoma,
the retina caused by retinal toxicity,
who also had normal achromatic
diabetic macular edema, and age-related mac- perimetry.3 This allows clinicians to identify
ular degeneration. It can be particularly useful patients whose visual field tests are normal,
in suspected hydroxychloroquine retinal toxic- but still can benefit from treatment.
ity, which is difficult to detect in early stages.
As in most diseases, glaucoma treatment is
The second protocol is a contrast sensitivity most effective when started early. Detection of
test that helps detect glaucoma and diabetic failing retinal ganglion cells before they are
retinopathy. Different contrast grids project irretrievably lost could open all new possibilionto the macula and the resulting electrical ac- ties for glaucoma therapy.
tivity produces an easy to interpret waveform.
While the most common test for glaucoma is
Pattern ERG testing can be used together likely measuring IOP, clinicians also use OCT
with VEP tests to help the clinician differenti- imaging, visual field tests, and other means of
ate between retinal and optic nerve disorders, analysis. However, there are still patients with
as well as improve sensitivity and specificity a normal RNFL appearance and unexplained
in diagnosing neuropathies and maculopathies scores on visual field examination. VEP and
when used in conjunction with other tests. It ERG testing provide another, completely obis a means of objectively detecting early-stages jective, means of evaluating a patient’s neuroof disease that is completely independent of visual pathway. This additional information
patient response, so it can clarify results of can make the difference in diagnosis and desubjective functional tests and pinpoint the termination of treatment.
take-home
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c a se st u dy
In the example of a case study, as shown on
page 19, a white male aged 53 years and suspected of having glaucoma has enlarged and
asymmetric cupping. His IOP ranges from 11
to 16 mm Hg. This patient’s visual field test results show many false positive responses in the
left eye. The HRT shows an increased cup, OS
compared with OD with borderline RNFL. The
fundus photos show greater cup to disc ratio
OS, confirming the HRT. The VEP low-contrast
test showed slight delay in latency OS. The
Contrast Sensitivity ERG test showed slightly
reduced magnitude and irregular waveform
OD and the magnitude was greatly reduced
OS with more irregular waveform.
Based on the delay in VEP combined with
poor waveforms and magnitudes in ERG tests
and information shown in HRT and visual field,
aggressive treatment is recommended for OS
and to lower IOP in both eyes. The patient will
return for repeat PERG/VEP in 1 year while
on treatment. ■
References
1. Leske MC, Heijl A, Hussein M, et al. for the Early
Manifest Glaucoma Trial Group. Factors for
glaucoma progression and the effect of treatment:
the early manifest glaucoma trial. Arch Ophthalmol.
2003;121:48-56.
2. Banitt MR, Ventura LM, Feuer WJ, et al. Progressive
loss of retinal ganglion cell function precedes structural
loss by several years in glaucoma suspects. Invest
Ophthalmol Vis Sci. 2013;54:2346-2352.
3. Derr PH, et al. Evaluation of pre-perimetric glaucoma
patients using short duration transient visual evoked
potentials (SD-tVEP). Presented at the Association
for Research in Vision and Ophthalmology annual
conference. May 2014, Orlando.
Mark a. Latina, MD, is an associate clinical professor of
ophthalmology at Tufts University Medical School and a surgeon in
ophthalmology at Massachusetts Eye and Ear, Boston. He also has a
private practice in Reading, MA. Dr. Latina can be reached via e-mail at: mark.latina2@
verizon.net. He did not indicate a fnancial interest in the subject matter.
ES557865_OT020115_020.pgs 01.22.2015 22:37
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ES557981_OT020115_021_FP.pgs 01.23.2015 00:40
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LUMIGAN 0.01%
(bimatoprost ophthalmic solution)
®
At doses at least 41 times the maximum intended human exposure based on blood
AUC levels, the gestation length was reduced in the dams, the incidence of dead
fetuses, late resorptions, peri- and postnatal pup mortality was increased, and pup
body weights were reduced.
There are no adequate and well-controlled studies of LUMIGAN® (bimatoprost
ophthalmic solution) 0.01% administration in pregnant women. Because animal
Brief Summary—Please see the LUMIGAN® 0.01% package insert for full
reproductive studies are not always predictive of human response LUMIGAN® 0.01%
Prescribing Information.
should be administered during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction
Nursing Mothers: It is not known whether LUMIGAN® 0.01% is excreted in human
of elevated intraocular pressure in patients with open angle glaucoma or
milk, although in animal studies, bimatoprost has been shown to be excreted in
breast milk. Because many drugs are excreted in human milk, caution should be
CONTRAINDICATIONS
exercised when LUMIGAN® 0.01% is administered to a nursing woman.
None
Pediatric Use: Use in pediatric patients below the age of 16 years is not recommended
because of potential safety concerns related to increased pigmentation following
long-term chronic use.
Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes
to pigmented tissues. The most frequently reported changes have been increased Geriatric Use: No overall clinical differences in safety or effectiveness have been
pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is observed between elderly and other adult patients.
expected to increase as long as bimatoprost is administered. The pigmentation Hepatic Impairment: In patients with a history of liver disease or abnormal ALT,
change is due to increased melanin content in the melanocytes rather than to AST and/or bilirubin at baseline, bimatoprost 0.03% had no adverse effect on liver
an increase in the number of melanocytes. After discontinuation of bimatoprost, function over 48 months.
pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital OVERDOSAGE
tissue and eyelash changes have been reported to be reversible in some patients. No information is available on overdosage in humans. If overdose with LUMIGAN®
Patients who receive treatment should be informed of the possibility of increased (bimatoprost ophthalmic solution) 0.01% occurs, treatment should be symptomatic.
pigmentation. The long term effects of increased pigmentation are not known.
In oral (by gavage) mouse and rat studies, doses up to 100 mg/kg/day did not
Iris color change may not be noticeable for several months to years. Typically, the produce any toxicity. This dose expressed as mg/m2 is at least 210 times higher than
brown pigmentation around the pupil spreads concentrically towards the periphery the accidental dose of one bottle of LUMIGAN® 0.01% for a 10 kg child.
of the iris and the entire iris or parts of the iris become more brownish. Neither nevi
nor freckles of the iris appear to be affected by treatment. While treatment with NONCLINICAL TOXICOLOGY
LUMIGAN® (bimatoprost ophthalmic solution) 0.01% can be continued in patients Carcinogenesis, Mutagenesis, Impairment of Fertility: Bimatoprost was not
who develop noticeably increased iris pigmentation, these patients should be carcinogenic in either mice or rats when administered by oral gavage at doses
of up to 2 mg/kg/day and 1 mg/kg/day respectively (at least 192 and 291 times
examined regularly [see Patient Counseling Information (17.1)].]
Eyelash Changes: LUMIGAN® 0.01% may gradually change eyelashes and vellus the recommended human exposure based on blood AUC levels respectively) for
hair in the treated eye. These changes include increased length, thickness, and 104 weeks.
number of lashes. Eyelash changes are usually reversible upon discontinuation Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse
lymphoma test, or in the in vivoo mouse micronucleus tests.
of treatment.
Intraocular Inflammation: Prostaglandin analogs, including bimatoprost, have been Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day
reported to cause intraocular inflammation. In addition, because these products may (at least 103 times the recommended human exposure based on blood AUC levels).
exacerbate inflammation, caution should be used in patients with active intraocular PATIENT COUNSELING INFORMATION
inflammation (e.g., uveitis).
Potential for Pigmentation: Advise patients about the potential for increased brown
Macular Edema: Macular edema, including cystoid macular edema, has been pigmentation of the iris, which may be permanent. Also inform patients about the
®
reported during treatment with bimatoprost ophthalmic solution. LUMIGAN 0.01% possibility of eyelid skin darkening, which may be reversible after discontinuation of
should be used with caution in aphakic patients, in pseudophakic patients with a LUMIGAN® (bimatoprost ophthalmic solution) 0.01%.
torn posterior lens capsule, or in patients with known risk factors for macular edema.
Potential for Eyelash Changes: Inform patients of the possibility of eyelash and
Bacterial Keratitis: There have been reports of bacterial keratitis associated with vellus hair changes in the treated eye during treatment with LUMIGAN® 0.01%.
the use of multiple-dose containers of topical ophthalmic products. These containers These changes may result in a disparity between eyes in length, thickness,
had been inadvertently contaminated by patients who, in most cases, had a pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash
concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Counseling Information (17.3)].]
Handling the Container: Instruct patients to avoid allowing the tip of the dispensing
Use with Contact Lenses: Contact lenses should be removed prior to instillation of container to contact the eye, surrounding structures, fingers, or any other surface in
®
LUMIGAN 0.01% and may be reinserted 15 minutes following its administration.
order to avoid contamination of the solution by common bacteria known to cause
ocular infections. Serious damage to the eye and subsequent loss of vision may
ADVERSE REACTIONS
Clinical Studies Experience: Because clinical studies are conducted under widely result from using contaminated solutions.
varying conditions, adverse reaction rates observed in the clinical studies of a drug When to Seek Physician Advice: Advise patients that if they develop an intercurrent
cannot be directly compared to rates in the clinical studies of another drug and may ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular
reactions, particularly conjunctivitis and eyelid reactions, they should immediately
not reflect the rates observed in practice.
®
In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most seek their physician’s advice concerning the continued use of LUMIGAN 0.01%.
common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% Use with Contact Lenses: Advise patients that LUMIGAN® 0.01% contains
of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug benzalkonium chloride, which may be absorbed by soft contact lenses. Contact
reactions (reported in 1 to 4% of patients) with LUMIGAN® 0.01% in this study lenses should be removed prior to instillation of LUMIGAN® 0.01% and may be
included conjunctival edema, conjunctival hemorrhage, eye irritation, eye pain, eye reinserted 15 minutes following its administration.
pruritus, erythema of eyelid, eyelids pruritus, growth of eyelashes, hypertrichosis, Use with Other Ophthalmic Drugs: Advise patients that if more than one topical
instillation site irritation, punctate keratitis, skin hyperpigmentation, vision blurred, ophthalmic drug is being used, the drugs should be administered at least five (5)
and visual acuity reduced.
minutes between applications.
Postmarketing Experience: The following reaction has been identified during
®
postmarketing use of LUMIGAN 0.01% in clinical practice. Because it was reported
© 2014 Allergan, Inc., Irvine, CA 92612
voluntarily from a population of unknown size, estimates of frequency cannot be ®
made. The reaction, which has been chosen for inclusion due to either its seriousness,
frequency of reporting, possible causal connection to LUMIGAN® 0.01%, or a
Made in the U.S.A.
combination of these factors, includes headache.
APC87BO14 based on 71807US14.
Rx only
In postmarketing use with prostaglandin analogs, periorbital and lid changes including
deepening of the eyelid sulcus have been observed.
Pregnancy: Pregnancy Category C
Teratogenic effects: In embryo/fetal developmental studies in pregnant mice and
rats, abortion was observed at oral doses of bimatoprost which achieved at least 33
or 97 times, respectively, the maximum intended human exposure based on blood
AUC levels.
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ES557966_OT020115_022_FP.pgs 01.23.2015 00:39
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FeBruAry 1, 2015 :: Ophthalmology times
23
Special Report )
SurgIcAl And clInIcAl mAnAgement OF
Glaucoma
Microbypass trabecular stent delivers
signifcant and durable effcacy
At 3 years, mean IOP reduced 36%; improvement seen in reduction of daily medication use
by cheryl guttman Krader; Reviewed by Tobias H. Neuhann, MD
Munich ::
ImplantatIon of a sIngle
microbypass trabecular stent (iStent, Glaukos)—combined with small-incision cataract
surgery—provides safe and sustained IOPlowering, show data from follow-up through
3 years in a single-center study, according to
Tobias H. Neuhann, MD.
Dr. Neuhann first began performing the microinvasive glaucoma surgery about 4 years
ago, and has collected data from 62 eyes of 43
patients who underwent the
combined procedure. Data from
follow-up to 2 years were available for 45 eyes, and 41 eyes
had reached the 3-year visit.
At 3 years, mean IOP was
reduced 36% from its preopDr. Neuhann
erative medicated level. The
improvement was achieved with an 84% reduction in daily medication use and an excellent safety profile, said Dr. Neuhann, medical
director, AaM Augenklinik am Marienplatz,
Munich, Germany.
‘Blood is the enemy
of glaucoma surgery,
but in this case, it is
your friend because
it shows the stent is
in the right position.’
— Tobias H. Neuhann, MD
more medications. Mean IOP was 24.1 mm Hg
preoperatively on medication, was reduced to
14.2 mm Hg at 3 months and remained stable
throughout follow-up, averaging 14.5 mm Hg
at 24 months and 14.9 mm Hg at 36 months.
“We did not separate the eyes by diagnosis,
but we observed it did take a little bit longer
for the IOP to fall after surgery in the pseudoexfoliation cases compared with the openangle glaucoma patients,” Dr. Neuhann said.
Average medication use was reduced from
Dur able, efficient
“Patients with glaucoma who undergo cataract 1.8 preoperatively to 0.3 at month 6, 0.2 at
surgery typically achieve some IOP-lowering month 24, and 0.3 at month 36.
“At month 36, 79% of eyes had an
benefit, but it usually only perIOP of 16 mm Hg or less and 74%
sists for 6 to 12 months,” he said.
were medication free,” Dr. Neuhann
“Therefore, the magnitude and
said. “And the results at 36 months
durability of the efficacy of this
are similar looking at a consistently
combined MIGS-cataract surgery
Follow-up to 3
seen cohort of 39 eyes.”
is remarkable, and importantly, years in a study of
Best-corrected visual acuity
its benefit was achieved without eyes undergoing
(BCVA) was 20/40 or better in 44%
any intraoperative complications combination
of eyes preoperatively and in 93%
or any of the more serious com- cataract surgery with
of eyes at month 36.
plications that occur with filtra- implantation of a single
“The BCVA was excellent as we
tion surgery.”
microbypass trabecular
expect when we do cataract surThe study cohort included 39 eyes stent shows a 36%
gery,” Dr. Neuhann said.
with primary open-angle glaucoma, reduction from baseline
During the follow-up, two pa11 eyes with pseudoexfoliation, 10 mean medicated IOP
tients became intolerant to topical
eyes with ocular hypertension, and and 84% reduction in
and systemic IOP-lowering therapy
2 eyes with secondary glaucoma. daily medication use.
and underwent shunt surgery. One
Sixty percent of the eyes were surgically naïve, but 13% had prior trabeculectomy eye had photocoagulation.
The stent is placed into Schlemm’s canal
and others had undergone some laser procedure. Most of the eyes were being treated with through the same temporal, limbal incision
2 topical medications and 18 were using 3 or used for the cataract procedure and after fill-
take-home
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ImplantIng thE stEnt
VIDEO having completed phaco with
iOL implantation the goniolens is placed on the
cornea. The chamber angle is visualized. The stent
is guided through the trabecular meshwork into
Schlemm’s canal. Little bleeding can been seen
which is a positive sign saying that blood from the
collector vessels will run reverse.
Go to http://bit.ly/1J8Aiiz
(Video courtesy of Tobias H. Neuhann, MD)
ing the anterior chamber with viscoelastic,
Dr. Neuhann said.
Surgical pearlS
Offering some surgical tips to facilitate visualization, he suggested performing the insertion
from the temporal side with the help of a gonioscopic lens, tilting the microscope towards
the surgeon and patient’s head away. To guide
accurate placement of the stent, Dr. Neuhann
said he massages the collector channels and
veins until the channels fill with blood.
“When you see the blood, you know you
are where you want to go,” he said.
Eyes may rarely develop hyphema postoperatively from bleeding through the channels,
but in the absence of that event, postoperative
bleeding is a positive sign.
“Blood is the enemy of glaucoma surgery,
but in this case, it is your friend because it
shows the stent is in the right position,” Dr.
Neuhann added. ■
Tobias H. NeuHaNN, MD
Dr. Neuhann has no relevant fnancial interest to disclose.
ES558251_OT020115_023.pgs 01.23.2015 02:39
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24
Special Report )
surGIcal and clInIcal manaGemenT Of
Glaucoma
Latest combo drug demonstrates
broad effcacy in subgroup analyses
Agent provides broad applicability to treat ocular hypertension, open-angle glaucoma
By Cheryl Guttman Krader; Reviewed by Tony Realini, MD, MPH
Morgan town, w V ::
periority of the brinzolamide/fixed combination to its components in lowering IOP at all
subgroup analyses of IOP outcomes in the brinzo- four time points.
The pre-specified subgroup analyses inveslamide 1%/brimonidine 0.2% fixed combination (Simbrinza, Alcon Laboratories) pivotal tigated potential variations in IOP responses
trial demonstrate the product has broad appli- depending on baseline IOP (24 to 27, 38 to
cability for patients with ocular hypertension 36 mm Hg), age (<65, >65, 65 to 75, 75 to
and open-angle glaucoma, said Tony Realini, 85 years), gender, and ethnicity (Caucasian,
African American, and Hispanic).
MD, MPH.
Results for the overall population
“We are fortunate that we have
showed that at the 3-month visit,
so many options for IOP reduction
mean IOP across the four time points
at this time, and I welcome the inranged from 16.5 to 20.2 mm Hg
troduction of all new products,”
The protocols for
in the brinzolamide/brimonidine
said Dr. Realini, associate profesthe pivotal trials
fixed combination group, 19.5 to
sor of ophthalmology and director,
establishing the
21.2 mm Hg in eyes treated with
glaucoma fellowship, West Virginia
effcacy of the
brinzolamide, and 18.0 to 22.5 mm
University Health Sciences Center,
brinzolamide 1%/
Hg in the brimonidine group. For all
Morgantown. “Some transform the
brimonidine 0.2% fxed
four time points, the difference betherapeutic landscape and some
combination included
tween the fixed combination group
are niche products.
pre-planned analyses
and both the brinzolamide and bri“I have found that every prodof subgroups defned by
monidine group was statistically
uct is the ideal treatment for some
IOP and demographic
significant.
of my patients, and the brinzolcharacteristics.
The results of the subgroup analamide/brimonidine fixed combiyses showed that the IOP-lowering effect of the
nation expands our options,” he added.
The brinzolamide/brimonidine fixed com- brinzolamide/brimonidine fixed combination
bination pivotal trial program comprised two remained superior to that of its components at
parallel-arm, double-masked studies that en- all time points across all subgroups.
In addition, comparisons of the IOP-lowering
rolled a total of 690 patients with open-angle
glaucoma or ocular hypertension. Patients were effect of the brinzolamide/brimonidine fixed
randomly assigned 1:1:1 into three groups to combination were undertaken between sub-
Results fRom pRe-planned
take-home
‘The [agent] offers a fxed combination in which
both agents can be expected to provide optimal IOP
reduction in patients on systemic beta-blocker therapy
in whom topical beta-blockers are less effective in
lowering IOP.’ — Tony Realini, MD, MPH
receive the fixed combination or its components as monotherapy.
IOP measurements were obtained at 8 a.m.
(trough), 10 a.m., 3 p.m., and 5 p.m. The primary endpoint visit was at 3 months, and the
analyses of those data showed statistical su-
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groups within each category, and those results
showed it had the same efficacy profile regardless of baseline IOP, age, gender, and ethnicity.
The brinzolamide/brimonidine fixed combination brings value to the medical armamentarium as the first fixed combination IOP-
Online Exclusive
fIlTraTIOn devIce
lOwers IOP In PaTIenTs
wITh PeG and POaG
OutcOmes Of impLantatiOn for
a glaucoma filtration device (ExPress,
Alcon Laboratories) in pseudoexfoliative
glaucoma (PEG) and primary-open angle
glaucoma (POAG) demonstrated significant
decreases in IOP and anti-glaucoma
medication use in both groups in a recent
comparison study.
Go to http://bit.ly/15fYJv0
lowering product without a beta-blocker, Dr.
Realini noted.
“Now patients with contraindications to
beta-blockers can enjoy the benefits of fixed
combination therapy,” he said.
“In addition, the [agent] offers a fixed combination in which both agents can be expected
to provide optimal IOP reduction in patients on
systemic beta-blocker therapy in whom topical beta-blockers are less effective in lowering IOP,” he said.
Dr. Realini also observed that unlike betablockers, both brinzolamide and brimonidine
provide additive IOP reduction when used in
conjunction with a prostaglandin analogue.
“The brinzolamide/brimonidine fixed combination represents the first fixed combination
containing two agents both known to provide
additive IOP reduction when used in conjunction with a PGA,” he said.■
Tony Realini, MD, MPH
Dr. Realini is a consultant to Alcon Laboratories and receives research support from
Lumenis.
ES557947_OT020115_024.pgs 01.23.2015 00:02
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SYMPTOMATIC VITREOMACULAR
ADHESION (VMA)
SYMPTOMATIC VMA MAY LEAD TO VISUAL IMPAIRMENT FOR YOUR PATIENTS1-3
IDENTIFY
REFER
Recognize metamorphopsia as a key sign of symptomatic VMA
and utilize OCT scans to confirm vitreomacular traction.
Because symptomatic VMA is a progressive condition that may lead
to a loss of vision, your partnering retina specialist can determine
if treatment is necessary.1-3
THE STEPS YOU TAKE TODAY MAY MAKE A DIFFERENCE
FOR YOUR PATIENTS TOMORROW
© 2014 ThromboGenics, Inc. All rights reserved. ThromboGenics, Inc., 101 Wood Avenue South, Suite 610, Iselin, NJ 08830 – USA. THROMBOGENICS and the THROMBOGENICS logo are trademarks or registered trademarks of
ThromboGenics NV. 9/14 OCRVMA0220
References: 1. Sonmez K, Capone A, Trese M, et al. Vitreomacular traction syndrome: impact of anatomical configuration on anatomical and visual outcomes. Retina. 2008;28:1207-1214. 2. Hikichi T, Yoshida A,
Trempe CL. Course of vitreomacular traction syndrome. Am J Ophthalmol. 1995;119(1):55-56. 3. Stalmans P, Lescrauwaet B, Blot K. A retrospective cohort study in patients with diseases of the vitreomacular interface (ReCoVit).
Poster presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting; May 4-8, 2014; Orlando, Florida.
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26
FeBruAry 1, 2015 :: Ophthalmology Times
Special Report )
SurGIcAl And clInIcAl mAnAGement oF
Glaucoma
AIG identifes prognostic value
for FD-OCT in predicting glaucoma
Ganglion cell complex focal loss volume had the strongest prognostic value in analysis
By Cheryl Guttman Krader; Reviewed by David Huang, MD, PhD
Por t l and, or ::
Fourier-domain optical coherence tomography (FD-OCT; also known as
spectral-domain OCT) may be useful in the initial risk assessment and treatment decisions
for patients at risk of developing visual field
damage from glaucoma, said David Huang,
MD, PhD.
This assessment was based on findings from
the Advanced Imaging for Glaucoma (AIG) Study
that enrolled 513 eyes with a normal or borderline visual field that were
glaucoma suspect or had preperimetric glaucoma. Study
participants were assessed
every 6 months, and during
a median follow-up of about
4.3 years, 55 eyes converted
Dr. Huang
to perimetric glaucoma or definitive visual field damage.
Cox regression analysis was used to investigate the prognostic significance of various FDOCT parameters and other baseline variables
representing demographic characteristics, visual field parameters, and ocular characteris-
ment had a four-fold greater risk of develop- nerve head or nerve fiber layer defect visible on
ing visual damage within 6 years than those ophthalmoscopy and the remaining 154 were
categorized as glaucoma suspects
with a normal GCC-FVL, 41% verbased on presence of ocular hypersus 10%, respectively.
tension or glaucoma in the fellow
“Conventional wisdom says that
eye in the absence of an optic nerve
an abnormal FD-OCT in a patient
head or nerve fiber layer defect.
with a normal or borderline visual
Analyses of data
All centers used the same platfield could just be red disease,” Dr. from the Advanced
forms for FD-OCT imaging (RTVue,
Huang said. “However, these data Imaging for Glaucoma
Optovue) and visual field testing
suggest it is more likely to be real Study (AIG) showed
(HFA II SITA 24-2, Carl Zeiss Meddisease that will take several years many Fourier-domain
itec). The FD-OCT scans mapped
before it manifests as visual field optical coherence
disc topography, nerve fiber layer
loss, and that appears to be espe- tomography parameters
(NFL) thickness, and GCC thickcially true if there is a borderline were signifcant risk
ness. The criterion for confirming
or abnormal GCC-FLV.”
factors for glaucoma
conversion to glaucoma required
Investigators also found that com- onset in eyes that were
three consecutive abnormal visual
pared with GCC-FVL alone, the ac- glaucoma suspect or
fields.
curacy of predicting conversion to had pre-perimetric
Gender, race, axial length, IOP,
glaucoma could be increased sig- glaucoma.
and central corneal thickness were
nificantly by combining that term
with age, visual field pattern standard devia- not significant predictors of glaucoma conversion.
“Because the AIG Study is not a randomized
tion, and nerve fiber layer inferior thickness in
a composite value they termed the Glaucoma trial, the clinician could use IOP and central
corneal thickness to make treatment decisions,”
Composite Conversion Index (GCCI).
The GCCI had an AROC of 0.783. With pa- he said. “Therefore, it is not surprising that
these known risk factors were not predictive
of glaucoma conversion, and no conclusion
should be drawn from this study regarding
the link between IOP, central corneal thickness and glaucoma progression based on the
AIG Study.”
The AIG Study was intended to test the use— David Huang, MD
fulness of OCT in glaucoma evaluation. OCT
results were masked to the treating clinicians
tients divided into quartiles according to their during the study period, so the predictive value
baseline GCCI, those in the highest quartile of OCT could be established without bias, Dr.
(GCCI >0.84) had about a 30% rate of conver- Huang noted. ■
sion to glaucoma, which was almost nine-fold
higher than the 3.6% conversion rate for eyes
in the lowest GCCI quartile, which had values
ranging from 0.33 to 0.62.
DaviD Huang MD, PHD
Dr. Huang is the principal investigator of
the NIH-supported AIG grant, which included
This article was adapted from Dr. Huang’s presentation at the 2014 meeting of the
a prospective longitudinal observational study
American Academy of Ophthalmology. Dr. Huang has a signifcant fnancial interest in
performed at three clinical centers (www.AIGCarl Zeiss Meditec. Oregon Health and Science University (OHSU) and Dr. Huang have
Study.net). Follow-up in the AIGS was coma signifcant fnancial interest in Optovue, a company that may have a commercial
pleted in 2013. Of the 513 eyes that it included,
interest in the results of this research and technology. These potential conficts of
359 had pre-perimetric glaucoma with an optic
interest have been reviewed and managed by OHSU.
take-home
‘Because the AIG Study is not a randomized trial, the
clinician could use IOP and central corneal thickness
to make treatment decisions.’
tics. The univariate analysis identified 16 variables with prognostic significance, including
five of the six FD-OCT variables tested.
Ganglion cell complex focal loss volume
(GCC-FLV), a measure of focal defect in the
macula, emerged as the strongest predictor of
all the variables tested, with an area under
the receiver operating curve (AROC) of 0.753,
according to Dr. Huang, Peterson Professor of
Ophthalmology, professor of biomedical engineering Casey Eye Institute, Oregon Health and
Science University, Portland.
Kaplan-Meier analyses showed that eyes with
a borderline or abnormal GCC-FLV at enroll-
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ES557907_OT020115_026.pgs 01.22.2015 23:20
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ES558007_OT020115_027_FP.pgs 01.23.2015 00:41
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COMBIGAN
®
(brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%
BRIEF SUMMARY
Please see the COMBIGAN® package insert for full prescribing information.
COMBIGAN® (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha adrenergic receptor
agonist with a beta adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in
patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately
controlled IOP; the IOP-lowering of COMBIGAN® dosed twice a day was slightly less than that seen with the concomitant
administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic
solution dosed three times per day.
CONTRAINDICATIONS
Asthma, COPD: COMBIGAN® is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe
chronic obstructive pulmonary disease.
Sinus bradycardia, AV block, Cardiac failure, Cardiogenic shock: COMBIGAN® is contraindicated in patients with
sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock.
Neonates and Infants (Under the Age of 2 Years): COMBIGAN® is contraindicated in neonates and infants
(under the age of 2 years).
Hypersensitivity reactions: Local hypersensitivity reactions have occurred following the use of different components
of COMBIGAN®. COMBIGAN® is contraindicated in patients who have exhibited a hypersensitivity reaction to any
component of this medication in the past.
Potentiation of respiratory reactions including asthma: COMBIGAN® contains timolol maleate; and although
administered topically can be absorbed systemically. Therefore, the same types of adverse reactions found with systemic
administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory
reactions including death due to bronchospasm in patients with asthma have been reported following systemic or
ophthalmic administration of timolol maleate.
Cardiac Failure: Sympathetic stimulation may be essential for support of the circulation in individuals with diminished
myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.
In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over
a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, COMBIGAN®
should be discontinued.
Obstructive Pulmonary Disease: Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis,
emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease [other than
bronchial asthma or a history of bronchial asthma, in which COMBIGAN® is contraindicated] should, in general, not
receive beta-blocking agents, including COMBIGAN®.
Potentiation of vascular insufficiency: COMBIGAN® may potentiate syndromes associated with vascular insufficiency.
COMBIGAN® should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s
phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Increased reactivity to allergens: While taking beta-blockers, patients with a history of atopy or a history of severe
anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic
challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat
anaphylactic reactions.
Potentiation of muscle weakness: Beta-adrenergic blockade has been reported to potentiate muscle weakness
consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been
reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
Masking of hypoglycemic symptoms in patients with diabetes mellitus: Beta-adrenergic blocking agents should be
administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with
labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may
mask the signs and symptoms of acute hypoglycemia.
Masking of thyrotoxicosis: Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of
hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal
of beta-adrenergic blocking agents that might precipitate a thyroid storm.
Ocular Hypersensitivity: Ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic
solutions 0.2%, with some reported to be associated with an increase in intraocular pressure.
Contamination of topical ophthalmic products after use: There have been reports of bacterial keratitis associated with
the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated
by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Impairment of beta-adrenergically mediated reflexes during surgery: The necessity or desirability of withdrawal
of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs
the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general
anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced
protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been
reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of
beta-adrenergic receptor blocking agents.
If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses
of adrenergic agonists.
ADVERSE REACTIONS
Clinical Studies Experience: Because clinical studies are conducted under widely varying conditions, adverse reaction
rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug
and may not reflect the rates observed in practice. COMBIGAN®: In clinical trials of 12 months duration with COMBIGAN®,
the most frequent reactions associated with its use occurring in approximately 5% to 15% of the patients included: allergic
conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. The following
adverse reactions were reported in 1% to 5% of patients: asthenia, blepharitis, corneal erosion, depression, epiphora, eye
discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation,
headache, hypertension, oral dryness, somnolence, superficial punctate keratitis, and visual disturbance.
Other adverse reactions that have been reported with the individual components are listed below.
Brimonidine Tartrate (0.1%-0.2%): Abnormal taste, allergic reaction, blepharoconjunctivitis, blurred vision, bronchitis,
cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, fatigue, flu
syndrome, follicular conjunctivitis, gastrointestinal disorder, hypercholesterolemia, hypotension, infection (primarily colds
and respiratory infections), hordeolum, insomnia, keratitis, lid disorder, nasal dryness, ocular allergic reaction, pharyngitis,
photophobia, rash, rhinitis, sinus infection, sinusitis, taste perversion, tearing, visual field defect, vitreous detachment,
vitreous disorder, vitreous floaters, and worsened visual acuity. Timolol (Ocular Administration): Body as a whole:
chest pain; Cardiovascular: Arrhythmia, bradycardia, cardiac arrest, cardiac failure, cerebral ischemia, cerebral vascular
accident, claudication, cold hands and feet, edema, heart block, palpitation, pulmonary edema, Raynaud’s phenomenon,
syncope, and worsening of angina pectoris; Digestive: Anorexia, diarrhea, nausea; Immunologic: Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, insomnia, nightmares,
paresthesia, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation,
nervousness, and memory loss; Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis; Hypersensitivity: Signs and
symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and generalized and localized rash;
black
Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), dyspnea, nasal
congestion, respiratory failure; Endocrine: Masked symptoms of hypoglycemia in diabetes patients; Special Senses:
diplopia, choroidal detachment following filtration surgery, cystoid macular edema, decreased corneal sensitivity,
pseudopemphigoid, ptosis, refractive changes, tinnitus; Urogenital: Decreased libido, impotence, Peyronie’s disease,
retroperitoneal fibrosis.
Postmarketing Experience: Brimonidine: The following reactions have been identified during post-marketing use of
brimonidine tartrate ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population
of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to
either their seriousness, frequency of reporting, possible causal connection to brimonidine tartrate ophthalmic solutions,
or a combination of these factors, include: bradycardia, depression, iritis, keratoconjunctivitis sicca, miosis, nausea, skin
reactions (including erythema, eyelid pruritus, rash, and vasodilation), and tachycardia. Apnea, bradycardia, hypotension,
hypothermia, hypotonia, and somnolence have been reported in infants receiving brimonidine tartrate ophthalmic
solutions. Oral Timolol/Oral Beta-blockers: The following additional adverse reactions have been reported in clinical
experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of
ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm
with respiratory distress; Body as a whole: Decreased exercise tolerance, extremity pain, weight loss; Cardiovascular:
Vasodilatation, worsening of arterial insufficiency; Digestive: Gastrointestinal pain, hepatomegaly, ischemic colitis,
mesenteric arterial thrombosis, vomiting; Hematologic: Agranulocytosis, nonthrombocytopenic purpura, thrombocytopenic
purpura; Endocrine: Hyperglycemia, hypoglycemia; Skin: Increased pigmentation, pruritus, skin irritation, sweating;
Musculoskeletal: Arthralgia; Nervous System/Psychiatric: An acute reversible syndrome characterized by disorientation
for time and place, decreased performance on neuropsychometrics, diminished concentration, emotional lability, local
weakness, reversible mental depression progressing to catatonia, slightly clouded sensorium, vertigo; Respiratory:
Bronchial obstruction, rales; Urogenital: Urination difficulties.
DRUG INTERACTIONS
Antihypertensives/Cardiac Glycosides: Because COMBIGAN® may reduce blood pressure, caution in using drugs
such as antihypertensives and/or cardiac glycosides with COMBIGAN® is advised. Beta-adrenergic Blocking
Agents: Patients who are receiving a beta-adrenergic blocking agent orally and COMBIGAN® should be observed
for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two
topical beta-adrenergic blocking agents is not recommended. Calcium Antagonists: Caution should be used in the
co-administration of beta-adrenergic blocking agents, such as COMBIGAN®, and oral or intravenous calcium
antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In
patients with impaired cardiac function, co-administration should be avoided. Catecholamine-depleting Drugs: Close
observation of the patient is recommended when a beta blocker is administered to patients receiving catecholaminedepleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or
marked bradycardia, which may result in vertigo, syncope, or postural hypotension. CNS Depressants: Although
specific drug interaction studies have not been conducted with COMBIGAN®, the possibility of an additive or potentiating
effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Digitalis
and Calcium Antagonists: The concomitant use of beta-adrenergic blocking agents with digitalis and calcium
antagonists may have additive effects in prolonging atrioventricular conduction time. CYP2D6 Inhibitors: Potentiated
systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with
CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol. Tricyclic Antidepressants: Tricyclic antidepressants have been
reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these
agents with COMBIGAN® in humans can lead to resulting interference with the IOP-lowering effect. Caution, however,
is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
Monoamine oxidase inhibitors: Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism
of brimonidine and potentially result in an increased systemic side-effect such as hypotension. Caution is advised in
patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
Pregnancy: Pregnancy Category C: Teratogenicity studies have been performed in animals.
Brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6
through 18 in rabbits. The highest doses of brimonidine tartrate in rats (1.65 mg/kg/day) and rabbits (3.33 mg/kg/day)
achieved AUC exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with
COMBIGAN®, 1 drop in both eyes twice daily.
Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum
recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (MRHOD)] demonstrated no evidence of fetal
malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on
postnatal development of offspring. Doses of 1,000 mg/kg/day (83,000 times the MRHOD) were maternotoxic in mice
and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses
8,300 times the MRHOD without apparent maternotoxicity.
There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed
the placenta and entered into the fetal circulation to a limited extent. Because animal reproduction studies are not always
predictive of human response, COMBIGAN® should be used during pregnancy only if the potential benefit to the mother
justifies the potential risk to the fetus.
Nursing Mothers: Timolol has been detected in human milk following oral and ophthalmic drug administration. It is not
known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been
shown to be excreted in breast milk. Because of the potential for serious adverse reactions from COMBIGAN® in nursing
infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
Pediatric Use: COMBIGAN® is not recommended for use in children under the age of 2 years. During post-marketing
surveillance, apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants
receiving brimonidine. The safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in
children below the age of two years.
The safety and effectiveness of COMBIGAN® have been established in the age group 2-16 years of age. Use of
COMBIGAN® in this age group is supported by evidence from adequate and well-controlled studies of COMBIGAN® in
adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and
timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). In this study, brimonidine tartrate
ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. The most commonly
observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. In pediatric
patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). Approximately 16% of
patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
OVERDOSAGE
No information is available on overdosage with COMBIGAN® in humans. There have been reports of inadvertent
overdosage with timolol ophthalmic solution resulting in systemic effects similar to those seen with systemic
beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm,
and cardiac arrest. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should
be maintained.
Rx Only
©2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
APC33KM13
®
Based on package insert 72060US13 revised 10/2012.
ES557964_OT020115_028_FP.pgs 01.23.2015 00:39
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29
Special Report )
SurgIcal anD clInIcal ManageMent of
glaucoma
First-in-class glaucoma therapy shows
promise in 28-day phase II study
rho kinase/norepinephrine transport inhibitor (0.02%) was non-inferior to latanoprost
By cheryl guttman Krader; Reviewed by Jason Bacharach, MD
Sonoma Coun t y, Ca ::
Results fRom a phase II study
showed that topical AR-13324 0.02% (Rhopressa, Aerie Pharmaceuticals)—an investigational rho kinase/norepinephrine transporter (ROCK/NET) inhibitor—significantly
reduced IOP in eyes with ocular hypertension
or open-angle glaucoma.
Based on the findings from that trial, a phase
III registration trial was designed and is now
under way comparing once-daily AR-13324
0.02% with twice-daily timolol 0.5%.
“The phase II data suggest
that AR-13324 0.02% may be
an excellent option for initial
treatment in eyes with lower
IOP, and the phase III study investigating its use is enrolling
eyes with unmedicated IOPs
Dr. bacharach
ranging from >20 to <27 mm
Hg,” said Jason Bacharach, MD, a glaucoma
specialist in Sonoma County, CA.
“We are hopeful in seeing positive results
in this large cohort,” he added.
did not meet the protocol criterion for noninferiority to the prostaglandin analogue.
However, findings from a pre-specified subset
analysis of patients stratified by unmedicated
baseline IOP showed that AR-13324 0.02%
was non-inferior to latanoprost in eyes with
baseline IOP ≤26 mm Hg.
In the latter subgroup, the mean decrease
in diurnal IOP was 5.7 mm Hg for eyes treated
with AR-13324 0.02% and 6.0 mm Hg in the
latanoprost-treated eyes.
The clinical study was recently published
online in Ophthalmology, and the paper will
appear in the February 2015 issue of the journal. Dr. Bacharach is lead author of the paper.
r eason for iop-low er ing
effic acy
The explanation for the similar IOP-lowering
efficacy of AR-13324 0.02% and latanoprost
in eyes with IOP ≤26 mm Hg is not that the
ROCK /NET inhibitor is more effective when
treating these lower IOPs.
Rather, the study findings reflect the fact
that latanoprost and all prostaglandin analogues work less well for decreasing IOP
aBout the phase ii
the lower the starting level, according to
c l i n ic a l st u dy
The phase II study randomly assigned 224 pa- Dr. Bacharach.
“This is a well-known phenomenon obtients with an unmedicated IOP between 22 and
36 mm Hg to treatment with AR-13324 0.01%, served in the original registration studies for
AR-13324 0.02%, or latanoprost 0.005%. Pa- latanoprost where for every 1 mm Hg lower
baseline IOP, the IOP-reducing eftients used their assigned study
fect of latanoprost was about 0.5
medication once daily in the evemm Hg less,” he said.
ning for 28 days.
The IOP inclusion criterion for
Mean unmedicated baseline
the
AR-13324 0.02% pivotal trial
diurnal IOP was similar in the
topical ar-13324
is not expected to have any imthree study groups and ranged 0.02% (rhopressa,
pact on its indication, presuming
from 25.5 to 25.8 mm Hg. At the aerie Pharmaceuticals)
efficacy and safety are demonend of the study, mean diurnal IOP signifcantly lowered
strated and the drug is approved,
in the AR-13324 0.01%, AR-13324 IoP in eyes with ocular
Dr. Bacharach added.
0.02%, and latanoprost groups hypertension or open“The phase II study showed
was reduced by 5.5, 5.7, and 6.8 angle glaucoma in a
that
AR-13324 was also very efmm Hg, respectively.
28-day phase II study.
fective in eyes with higher IOPs,”
In all groups, the decrease from
baseline was statistically significant, accord- Dr. Bacharach said.
AR-13324 was generally safe and well toling to Dr. Bacharach.
With its approximately 1 mm Hg lesser ef- erated in the phase II study.
ficacy compared with latanoprost, AR-13324
Continues on page 30 : rocK/net
take-home
magenta
cyan
yellow
black
rapid advances
in clinical
development
Based on the results from the phase IIb
trial described here and recently published in Ophthalmology, Aerie initiated a full phase III program
for triple-action Rhopressa (AR-13324) in July 2014.
Two efficacy trials are being conducted in the United
States, designated “Rocket 1” and “Rocket 2.” The
primary efficacy endpoint in both studies is the demonstration of non-inferiority in IOP lowering over 3
months for Rhopressa compared with timolol, the
most widely used comparator in registration trials
for glaucoma.
A third 12-month, safety-only registration trial
(“Rocket 3”) is being conducted in Canada. Enrollment
in the 400-patient “Rocket 1” trial was completed
ahead of schedule in December 2014, allowing Aerie
to announce in January that the expected timeline
for reporting efficacy results from the study would
be accelerated from mid-2015 to the middle of the
second-quarter of this year. An efficacy read-out for
“Rocket 2” will take place by mid-2015.
If the trials are successful, Aerie plans to submit
a new drug application (NDA) for Rhopressa to the
FDA by mid-2016. Rhopressa, which inhibits both rho
kinase (ROCK) and norepinephrine transporter (NET),
could become the only once-daily product available
that specifically targets the trabecular meshwork,
the eye’s primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma, while
also lowering episcleral venous pressure (EVP) and
reducing fluid production in the eye. Pending regulatory approval, the company intends to commercialize Rhopressa in North American markets and possibly Europe with its own sales force and will seek
commercialization partners in other key territories,
including Japan and possibly Europe.
Next in the Aerie glaucoma pipeline is Roclatan
(PG324), a once-daily, fixed-dose combination of
Rhopressa with latanoprost, the most commonly prescribed prostaglandin analogue. If approved, Roclatan would be the first glaucoma product to lower
Continues on page 30
ES557337_OT020115_029.pgs 01.22.2015 02:39
ADV
30
Special Report )
SurgIcal anD clInIcal ManageMent of
rock/net
Ocular/conjunctival hyperemia was the
most common side effect and was recorded in
57% of eyes treated with AR-13324 0.02% and
16% of latanoprost-treated eyes, Dr. Bacharach noted.
However, the hyperemia associated with
AR-13324 was mild in most cases and seemed
to be most prominent in the evening postdosing and diminish overnight while patients
were asleep.
In addition, the incidence of hyperemia associated with AR-13324 decreased throughout
the study, whereas the incidence of conjunctival hyperemia in the latanoprost group increased with time.
M u lt iModa l act ions
for product
AR-13324 reduces IOP via several mechanisms. First, ROCK inhibition reduces resistance to outflow through the trabecular
meshwork.
In addition, AR-13324 reduces aqueous
humor production, which is thought to be
secondary to its NET inhibition, and there
is also evidence AR-13324 reduces episcleral
venous pressure.
BleB failure
and it’s safe when used at low concentrations,”
Dr. Martin explained.
His needling technique includes using apraclonidine 1% preoperatively, about 15 minutes before the procedure. This helps to vasoconstrict and reduce the risk of bleeding.
Dr. Martin prefers to use a bent 30-gauge
needle with viscoelastic, although a larger
needle may be helpful in cases with more
scarring. He also uses a lid speculum for
most cases.
If the bleb has formed, then subconjunctival needling may be all that is required.
However, a flat bleb may require elevation
of the scleral flap and entry into the anterior
chamber via a sclerotomy to establish flow.
An anterior chamber maintainer providing
positive pressure infusion can be very useful
magenta
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black
glaucoma
However, the ability of AR-13324 and related
drugs to increase trabecular meshwork outflow may provide a benefit in glaucoma that
is unrelated to reduction in IOP, Dr. Bacharach said.
“The aqueous humor contains nutrients
and antioxidants, and findings from preclinical studies suggest that restoration of aqueous
flow through the diseased trabecular meshwork may have a positive impact on the disease pathology,” he explained.
use with latanoprost
explored
AR-13324 0.02% is also being developed as
a fixed-combination product with latanoprost 0.005% (PG324 0.02%; Roclatan, Aerie
Pharmaceuticals).
Results of a randomized phase IIb clinical study showed that all post-treatment
timepoints, mean IOP was 1.6 to 3.2 mm
Hg lower in eyes treated with PG324 compared with using latanoprost 0.005% and 1.7
to 3.4 mm Hg lower compared with a AR13324 0.02% monotherapy group, according
to Dr. Bacharach.
“The results of the phase IIb study are very
encouraging and suggest that AR-13324 may
be an excellent addition to a prostaglandin
analogue for patients who do not respond
sufficiently to the prostaglandin alone,” Dr.
Bacharach said. ■
in these cases, helping establish good flow.
It is also possible to set the opening pressure and gauge the resistance by adjusting
the bottle height, according to Dr. Martin.
M a naging dif f icu lt
cases
Dr. Martin also offered tips for managing treatment for patients with difficult cases.
If the patient is unable to look down, a corneal traction suture may help in gaining access behind the flap.
Anterior chamber infusion using a Lewicky
23- or 25-gauge cannula and 3-way tap gives
the surgeon a greater degree of control over
the procedure.
Viscoelastic is also useful in challenging
cases, Dr. Martin said.
He added that it is often difficult to avoid
making a hole in the conjunctiva, particularly
when scarring is present.
“If this occurs very close to the flap, it’s
worth considering repairing these holes be-
IOP through all known mechanisms: increasing fluid
outflow through the trabecular meshwork; increasing fluid outflow through the uveoscleral pathway,
the eye’s secondary drain; reducing fluid production;
and lowering EVP.
A successful 28-day phase IIb clinical trial of Roclatan in 297 patients with glaucoma or ocular hypertension was completed in June 2014. In the study,
Roclatan achieved its primary efficacy endpoint of
statistically significant superiority compared to its
individual components in reducing mean diurnal IOP
over baseline on day 29. It also demonstrated statistical superiority to each component at all time
points. The results for the Rhopressa component
were similar to those in the single-agent phase IIb
study and the drug demonstrated additive efficacy
when used in combination with latanoprost. Aerie
expects to initiate phase III registration trials for
Roclatan in mid-2015.
Aerie fully owns both Rhopressa and Roclatan, has
no licenses, and has patent protection for both use
and composition of matter through 2030. ■
Jason Bacharach, MD
Dr. Bacharach is an investigator in the AR-13324 and PG-324 studies and is a
consultant to Aerie Pharmaceuticals. He was also a clinical trial investigator for a ROCK
inhibitor that was being developed by Amakem.
cause if you don’t you’re very likely to end up
with a flat bleb post-procedure,” he said. “If
you do repair these you can then proceed and
complete the viscodisscetion and separate the
planes more effectively.”
Finally, Dr. Martin urged his colleagues to
assess cases carefully before intervening.
“You’ve got to realize whether or not you’re
likely to achieve your target pressure in the
long term,” he said. “Repeated needlings over
and over again are often futile. We frequently
need to move on to consider alternative medical or surgical approaches.” ■
keith r. Martin, MD, frcophth
This article was adapted from Dr. Martin’s presentation during Glaucoma Subspecialty
Day presentation at the 2014 meeting of the American Academy of Ophthalmology. Dr.
Martin is a consultant and lecturer for Allergan.
ES557339_OT020115_030.pgs 01.22.2015 02:39
ADV
Richard Lindstrom, MD
Ophthalmologist and
noted refractive and
cataract surgeon.
Minnesota Eye Consultants
“Good lid and lash hygiene is not a sometime event.
Ab a chronic 3le_haricib bdŪerer� I dbe Aeenoea ab _arc
of my daily lid hygiene regimen. And I recommend
Avenova to my patients.”
Daily lid and lash hygiene.
Hypochlorous Acid in Solution
- Kills organisms
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� Breeencb OioŬlm formacion
OPHTHALMOLOGIST AND OPTOMETRIST TESTED
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ES557968_OT020115_031_FP.pgs 01.23.2015 00:39
ADV
FeBruary 1, 2015 :: Ophthalmology Times
32
Special Report )
SurGIcAl And clInIcAl MAnAGEMEnT Of
Glaucoma
novel IOP-lowering agent safe,
well-tolerated in pivotal phase III trial
latanoprostene bunod meets primary endpoint, many secondary endpoints
By Cheryl Guttman Krader; Reviewed by Robert N. Weinreb, MD
said Dr. Weinreb, chairman and distinguished
professor of ophthalmology, and director, Hamilton Glaucoma Center, University of California, San Diego. “Findings from the phase III
trials and earlier studies investigating latanoprostene bunod indicate it has promise to become an important new treatment option for
patients with open-angle glaucoma and ocular hypertension.”
The pivotal trial program for latanoprostene
bunod comprised two studies that randomly
assigned patients to 3 months of treatment with
latanoprostene bunod once daily or timolol
maleate 0.5% twice daily. IOP measurements
were obtained at 8 a.m., 12 p.m., and 4 p.m. at
visits conducted at baseline and after 2 weeks,
6 weeks, and 3 months. The phase III studies
are ongoing with a 9-month open-label safety
phase in which all participants are receiving
latanoprostene bunod.
“It is harder to reduce IOP if it is already
controlled,” Dr. Brown said.
He illustrated his point by presenting results
from the first 85 patients he implanted with the
microbypass trabecular stent
(iStent, Glaukos). Preoperative
“In fact, MIGS devices work best in the 95% IOPs for the group ranged from
of glaucoma patients who are 1 to 3 medica- <15 to >21 mm Hg.
However, when patients
tions, and it offers them a way to lower IOP and
reduce medication use along with the associ- were divided into 4 groups
ated burdens of medication,” Dr. Brown said. based on their preoperative
Dr. Brown
Nevertheless, he suggested surgeons who are IOP, those with the highest
just beginning to perform MIGS should pick IOP (>21 mm Hg) achieved a mean reduction
patients undergoing cataract surgery who are of almost 6 mm Hg, while IOP fell by 3.2 mm
on 1 or 2 IOP-lowering medications. These indi- Hg among those whose preoperative IOP was
viduals account for more than three-fourths of 19 to 21 mm Hg, but by only 1 mm Hg for papatients with glaucoma. Other criteria include tients with preoperative IOP 15 to 18 mm Hg,
and 0.5 mm Hg in those with an
mild to moderate glaucoma and IOP
even lower IOP.
that is relatively well controlled.
“Overall, 96.5% of patients whose
“When surgeons have more expreoperative IOP was 18 mm Hg or
perience, they might consider MIGS
above had a lower IOP after surfor patients on 3 medications as
Microinvasive
gery,” Dr. Brown said.
long as the patient still has minimal glaucoma surgery
Knowing the outcomes of MIGS
visual field loss and the IOP is not creates a new
also lets surgeons set proper extoo elevated,” he said. “Remember paradigm for the role of
pectations for patients.
that MIGS is not a replacement for glaucoma surgery and
“The goal of MIGS is to lower
trabeculectomy and tubes, and so is within the skillset of
IOP and it may be possible to reavoid patients with high IOP and cataract and cornea
duce the number of medications in
advanced visual field loss.”
surgeons.
patients with minimal visual field
loss. But do not overpromise,” Dr. Brown said.
identifyinG the riGht
He also reminded surgeons that they have
Candidate
Recognizing who is an appropriate candidate a parachute with MIGS.
“If the IOP gets too high, you can send the
for MIGS relates to understanding its outcomes.
MIGS can reduce IOP to the mid to upper teens patient to the glaucoma specialist,” he said.
Reiterating that MIGS is within the skillset
and/or lower medication use, but the amount
of IOP lowering that can be achieved depends of anyone who is already doing cataract surgery, Dr. Brown noted that surgeons still need
on the existing level.
to educate themselves and be prepared to face
a learning curve. Company-sponsored training for the iStent is available through Glaukos,
and surgeons can supplement that by reviewing videos and obtaining a nonsterile device to
practice delivery outside actual surgery.
“Expect some challenges,” he said. “You are
going to be using new technology and should
take advantage of the resources that are available to learn the technique.”
Dr. Brown added that gonioscopy is the most
important skill to learn, and he suggested surgeons should practice getting the best gonio
view possible on routine cases by turning the
head and microscope.
Dr. Brown concluded by noting MIGS is just
at its beginning. Although the iStent is the
only FDA-approved MIGS procedure, and it
is only approved for placement of a single device, other options are on the horizon. They
include insertion of two micro-bypass trabecular stents (iStent inject; Glaukos), suprachoroidal stents for improving uveoscleral outflow
(iStent Supra, Glaukos; CyPass Micro-Stent, Transcend Medical) and a flexible scaffold for permanently dilating and supporting Schlemm’s
canal (Hydrus, Ivantis).
In addition, combination approaches are
being explored that use two devices targeting different outflow pathways. ■
SAn DieGo ::
Results from the pivotal phase III trials investigating latanoprostene bunod 0.024% (Vesneo
ophthalmic suspension, Bausch + Lomb) show
that the novel, once-daily IOP-lowering agent
met its primary endpoint, was safe, and welltolerated, said Robert N. Weinreb, MD.
“Latanoprostene bunod is a new compound
that is rapidly metabolized in the eye to latanoprost acid and a nitric oxide-donating moiety,”
migs
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reay h. broWn, md
This article was adapted from Dr. Brown’s presentation at Cornea Subspecialty Day
during the 2014 meeting of the American Academy of Ophthalmology. Dr. Brown is a
consultant to Ivantis and Transcend and has a fnancial interest in Glaukos.
ES558283_OT020115_032.pgs 01.23.2015 03:15
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33
FeBruary 1, 2015 :: Ophthalmology Times
Special Report )
Online Exclusive
In ThE PIPElInE: nOvEl
MIGS STEnTS In vArIOuS
STAGES Of TrIAlS
SurGIcAl And clInIcAl MAnAGEMEnT Of
from baseline was 9 mm Hg for latanoprostene
bunod 0.024% and 7.8 mm Hg for latanoprost.
“We know from several studies that every
mm Hg of IOP reduction is important as it reduces both the risk of developing and the progression of glaucoma,” he said.
Latanoprostene bunod was discovered by re-
searchers at Nicox, Milan, Italy, and licensed to
Bausch+Lomb for commercial development. ■
robert n. Weinreb, md
Dr. Weinreb is a consultant to Aerie Pharma, Alcon, Allergan, and Bausch + Lomb.
A number Of InvestIgAtIOnAl implant
devices for managing glaucoma are in the
pipeline, and preliminary clinical trial data are
promising for some, said Angelo P. Tanna, MD,
vice chairman, Department of Ophthalmology,
and director of the Glaucoma Service,
Northwestern University Feinberg School of
Medicine, Chicago.
Choose BAK-free
TRAVATAN Z® Solution
for sustained
IOP lowering
Go to http://bit.ly/1ynASgX
The primary objective was to demonstrate that
the mean IOP reduction after 3 months of treatment with latanoprostene bunod was non-inferior
to that of timolol. As latanoprostene bunod met
its primary endpoint, the data were analyzed
to see if the IOP-lowering effect of latanoprostene bunod was superior to timolol. Data from
across all follow-up visits showed that latanoprostene bunod lowered IOP by 7.5 to 9.1 mm
Hg, and the differences compared with timolol
were consistently statistically significant.
“The IOP-lowering effect demonstrated by
latanoprostene bunod in the pivotal trials confirms the results of a phase IIb study that used
latanoprost as a comparator, and it was achieved
with a safety and tolerability profile similar to
standard of care latanoprost,” Dr. Weinreb said.
voyaGe r st u dy
The phase IIb study, known as VOYAGER, was a
randomized, investigator-masked, dose-ranging
study comparing four concentrations of latanoprostene bunod (0.006% to 0.040%) to latanoprost 0.005% (Xalatan, Pfizer). It randomly assigned 413 patients who met the eligibility criteria of having open-angle glaucoma or ocular
hypertension with IOP between 22 and 32 mm
Hg and ≥24 mm Hg for at least 2 of the 3 diurnal
measurements obtained at the baseline visit.
The results from VOYAGER, which were
published online in December 2014 with Dr.
Weinreb as the lead author [Br J Ophthalmol.
2014 Dec 8 Epub ahead of print], showed the
IOP-lowering effect of latanoprostene bunod
was dose-dependent, but reached a plateau at
0.024% to 0.040%. Latanoprostene bunod 0.024%,
the concentration studied in the pivotal trials,
demonstrated statistically significant superiority >1 mm Hg to latanoprost at all treatment
visits (days 7, 14, and 28). At the primary endpoint on day 28, mean diurnal IOP reduction
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Glaucoma
Sustained
30 % IOP lowering
at 12, 14, and 20 hours post-dose in a 3-month study1,2*
TRAVATAN Z® Solution has no FDA-approved therapeutic equivalent3
Help patients start strong and stay on track with the
Patient Support Program
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for
the reduction of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension.
Eyelash Changes—TRAVATAN Z® Solution may gradually change
eyelashes and vellus hair in the treated eye. These changes include
increased length, thickness, and number of lashes. Eyelash changes are
usually reversible upon discontinuation of treatment.
The recommended dosage is 1 drop in the affected eye(s) once daily in
the evening. TRAVATAN Z® Solution should not be administered more than
once daily since it has been shown that more frequent administration of
prostaglandin analogs may decrease the IOP-lowering effect.
TRAVATAN Z® Solution may be used concomitantly with other topical
ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic
drug is being used, the drugs should be administered at least 5 minutes
apart.
Use With Contact Lenses—Contact lenses should be removed prior to
instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes
following its administration.
IMPORTANT SAFETY INFORMATION
Pigmentation—Travoprost ophthalmic solution has been reported to
increase the pigmentation of the iris, periorbital tissue (eyelid), and
eyelashes. Pigmentation is expected to increase as long as travoprost is
administered. After discontinuation of travoprost, pigmentation of the iris
is likely to be permanent, while pigmentation of the periorbital tissue and
eyelash changes have been reported to be reversible in some patients.
The long-term effects of increased pigmentation are not known. While
treatment with TRAVATAN Z® Solution can be continued in patients who
develop noticeably increased iris pigmentation, these patients should be
examined regularly.
Adverse Reactions
The most common adverse reaction observed in controlled clinical studies
with TRAVATAN Z® Solution was ocular hyperemia, which was reported in
30 to 50% of patients. Up to 3% of patients discontinued therapy due to
conjunctival hyperemia. Ocular adverse reactions reported at an incidence
of 5 to 10% in these clinical studies included decreased visual acuity, eye
discomfort, foreign body sensation, pain, and pruritus. In postmarketing
use with prostaglandin analogs, periorbital and lid changes including
deepening of the eyelid sulcus have been observed.
Use in Specific Populations
Use in pediatric patients below the age of 16 years is not recommended
because of potential safety concerns related to increased pigmentation
following long-term chronic use.
For additional information about TRAVATAN Z® Solution, please see
the brief summary of Prescribing Information on the adjacent page.
*Study Design: Double-masked, randomized, parallel-group, multicenter non-inferiority comparison of the efficacy and safety of travoprost 0.004% preserved with benzalkonium chloride
(BAK) to TRAVATAN Z® Solution after 3 months of treatment in patients with open-angle glaucoma or ocular hypertension. Baseline IOPs were 27.0 mm Hg (n=322), 25.5 mm Hg (n=322),
and 24.8 mm Hg (n=322) at 8 AM, 10 AM, and 4 PM for TRAVATAN Z® Solution. At the end of Month 3, the TRAVATAN Z® Solution group had mean IOPs (95% CI) of 18.7 mm Hg (-0.4, 0.5),
17.7 mm Hg (-0.4, 0.6), and 17.4 mm Hg (-0.2, 0.8) at 8 AM, 10 AM, and 4 PM, respectively. Statistical equivalent reductions in IOP (95% confidence interval about the treatment differences
were entirely within ±1.5 mm Hg) were demonstrated between the treatments at all study visits during the 3 months of treatment.
References: 1. Data on file, 2013. 2. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with
and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma.
2007;16(1): 98-103. 3. Drugs@FDA. FDA Approved Drug Products: TRAVATAN Z. www.
accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
Accessed July 31, 2014.
© 2014 Novartis 9/14
TRV14066JAD
ES558282_OT020115_033.pgs 01.23.2015 03:15
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Special Report )
Glaucoma
Laser-assisted procedure brings ease,
precision, safety to deep sclerectomy
Approach offers effcacy comparable to trabeculectomy, non-penetrating deep sclerectomy
By Cheryl guttman Krader; Reviewed by Svetlana Anisimova, MD, PhD
Moscow ::
BRIEF SUMMARY OF PRESCRIBING INFORMATION
TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated
intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The recommended dosage is one drop in the affected eye(s) once daily in the evening.
TRAVATAN Z® (travoprost ophthalmic solution) should not be administered more than once daily
since it has been shown that more frequent administration of prostaglandin analogs may decrease
the intraocular
pressure lowering effect.
Reduction of the intraocular pressure starts approximately 2 hours after the first administration
with maximum effect reached after 12 hours.
TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products
to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs
should be
administered at least five (5) minutes apart.
CONTRAINDICATIONS
None
Pigmentation
Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The
most frequently reported changes have been increased pigmentation of the iris, periorbital tissue
(eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered.
The pigmentation change is due to increased melanin content in the melanocytes rather than
to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation
of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash
changes have been reported to be reversible in some patients. Patients who receive treatment
should be informed of the possibility of increased pigmentation. The long term effects of increased
pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or
parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected
by treatment. While treatment with TRAVATAN Z® (travoprost ophthalmic solution) 0.004% can be
continued in patients who develop noticeably increased iris pigmentation, these patients should
be examined regularly.
Eyelash Changes
TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These
changes include increased length, thickness, and number of lashes. Eyelash changes are usually
reversible upon discontinuation of treatment.
Intraocular Inflammation
TRAVATAN Z® Solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with
travoprost ophthalmic solution. TRAVATAN Z® Solution should be used with caution in aphakic
patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk
factors for macular edema.
Angle-closure, Inflammatory or Neovascular Glaucoma
TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory
or neovascular glaucoma.
Bacterial Keratitis
There have been reports of bacterial keratitis associated with the use of multiple-dose containers
of topical ophthalmic products. These containers had been inadvertently contaminated by patients
who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial
surface.
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be
reinserted 15 minutes following its administration.
ADVERSE REACTIONS
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates
observed in the clinical studies of a drug cannot be directly compared to rates in the clinical
studies of another drug and may not reflect the rates observed in practice. The most common
adverse reaction observed in controlled clinical studies with TRAVATAN® (travoprost ophthalmic solution) 0.004% and TRAVATAN Z® (travoprost ophthalmic solution) 0.004% was ocular
hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy
due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in
these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation,
pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies
with TRAVATAN® or TRAVATAN Z® Solutions included abnormal vision, blepharitis, blurred vision,
cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting,
ocular inflammation, photophobia, subconjunctival hemorrhage and tearing. Nonocular adverse
reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris,
anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression,
dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension,
infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. In
postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of
the eyelid sulcus have been observed.
Pregnancy
Pregnancy Category C
Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/
kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an
increase in the incidence of skeletal malformations as well as external and visceral malformations,
such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats
at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1
mcg/kg/day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses
and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in
mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD).
In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to
lactation Day 21 at doses of * 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal
mortality was increased, and neonatal body weight gain was decreased. Neonatal development
was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation,
and by decreased motor activity.
There are no adequate and well-controlled studies of TRAVATAN Z® (travoprost ophthalmic
solution) 0.004% administration in pregnant women. Because animal reproductive studies are
not always predictive of human response, TRAVATAN Z® Solution should be administered during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were
excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when TRAVATAN Z®
Solution is administered to a nursing woman.
Pediatric Use
Use in pediatric patients below the age of 16 years is not recommended because of potential
safety concerns related to increased pigmentation following long-term chronic use.
Geriatric Use
No overall clinical differences in safety or effectiveness have been observed between elderly
and other
adult patients.
Hepatic and Renal Impairment
Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment
and also in patients with renal impairment. No clinically relevant changes in hematology, blood
chemistry, or urinalysis laboratory data were observed in these patients.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/
kg/day did not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male
rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in
the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the
human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg,
based on plasma active drug levels. Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was
observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes.
Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up
to 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day
on a mcg/kg basis (MRHOD)]. At 10 mcg/kg/day, the mean number of corpora lutea was reduced,
and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/
day (75 times the MRHOD).
Potential for Pigmentation
Patients should be advised about the potential for increased brown pigmentation of the iris, which
may be permanent. Patients should also be informed about the possibility of eyelid skin darkening,
which may be reversible after discontinuation of TRAVATAN Z® (travoprost ophthalmic solution)
0.004%.
Potential for Eyelash Changes
Patients should also be informed of the possibility of eyelash and vellus hair changes in the
treated eye during treatment with TRAVATAN Z® Solution. These changes may result in a disparity
between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Handling the Container
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the
eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the
solution by common bacteria known to cause ocular infections. Serious damage to the eye and
subsequent loss of vision may result from using contaminated solutions.
When to Seek Physician Advice
Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma
or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and
eyelid reactions, they should immediately seek their physician’s advice concerning the continued
use of
TRAVATAN Z® Solution.
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be
reinserted 15 minutes following its administration.
Use with Other Ophthalmic Drugs
If more than one topical ophthalmic drug is being used, the drugs should be administered at least
five (5) minutes between applications.
Rx Only
U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2006, 2010, 2011, 2012 Novartis
4/13 TRV13021JAD
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CO2 laser-assisted sclerectomy
surgery (CLASS) performed with a proprietary platform (IOPtiMate System, IOPtima) is a
non-penetrating procedure for management of
medically uncontrolled open-angle glaucoma
that offers efficacy comparable to trabeculectomy and non-penetrating deep
sclerectomy (NPDS), but with
superior safety, according to
Prof. Svetlana Anisimova,
MD, PhD.
Dr. Anisimova, general director, EYE Center “VostokDr. Anisimova
Prozrenie, Moscow, Russia,
has been a pioneer in the development of NPDS and explained that by implementing use of the laser for dissecting the
scleral flap, CLASS overcomes the major challenge of NPDS, which is the risk of inadvertent
trabeculo-Descemet’s membrane perforation.
Because the wavelength of the CO2 laser is
absorbed by water, the device’s cutting effect
is halted when the dissection reaches the desired endpoint of fluid percolation.
Simplify the Surgery
In addition, the laser-assisted procedure and
features of the proprietary platform simplify
the surgery, further reducing the prolonged
learning curve characteristic of manual NPDS,
Dr. Anisimova said.
“NPDS has a better safety profile than trabeculectomy, but technical difficulty is one of
the main drawbacks of NPDS,” she said. “In
the hands of surgeons new to NPDS performing manual dissection with a knife, there is
a high rate of penetration, which leads to the
same complications as after trabeculectomy.
And, if the dissection doesn’t open the entire
width of trabecular, effective filtration may
not be achieved.”
CLASS transforms deep sclerectomy into safe,
convenient, elegant and precise laser-assisted
surgery that can be performed confidently by
surgeons with a wide range of experience in
filtration surgery. With CLASS, the microdissection is controlled and performed under direct microscopic observation.
“In addition, surgeons do not need to manually dissect layers of sclera and the drainage
ES557307_OT020115_034.pgs 01.22.2015 02:30
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Special Report )
Glaucoma
ThE class prOcEDurE
(Figure 1) drainage zone is opened during
non-penetrating deep sclerectomy (nPdS).
(Figure 2) nPdS + Xenoplast drainage.
(Images courtesy of Svetlana Anisimova, MD, PhD)
Medication use per patient decreased from
system or locate the orifice of the Schlemm’s
canal as they do in manual NPDS techniques, an average of 2.5 ± 1.5 preoperatively to 0.5
± 0.4 at 6 months and 1.6 ± 0.9
she said.
at 5 years after surgery.
The CO2 laser can be integrated
Additional procedures performed
with any ophthalmic microscope,
in the series included YAG laser
and the novel laser-assisted platgoniopuncture, carried out 4 to
form that is used for CLASS feaco2 laser-assisted
10 weeks after the initial surgery
tures a micro-manipulating scan- sclerectomy surgery
in 2 eyes, and combined surgery
ner that guides the laser beam, as- performed with a
(NPDS with phacoemulsification)
suring that the sclera is accurately proprietary platform
in 1 eye at 4 years after the CLASS
ablated per the pre-selected area offers an effective
procedure.
and pattern.
and safer alternative
“Goniopuncture was not conDr. Anisiomova began perform- to manual nonsidered a reason for failure or an
ing CLASS in June 2009, and has penetrating deep
adverse event as it is commonly
data on 9 eyes with follow-up to sclerectomy procedure
used after other glaucoma surgeries
5 years.
for the management of
to maintain or augment the operaMean (± SD) IOP was 27.3 ± medically uncontrolled
tive results,” Dr. Anisimova said.
4.8 mm Hg preoperatively, 17.4 ± open-angle glaucoma.
The recorded complications
2.4 mm Hg at 6 months, 18.3 ± 2.1
were mostly mild and transitory.
mm Hg at 12 months, and 17.5 ±
1.5 mm at 5 years of follow-up (6 patients were There were some microperforations, but no
macroperforations.
examined 5 years after surgery).
take-home
VIDEO watch as co2 laser-assisted
sclerectomy surgery (cLAss) is performed
by André Mermoud, MD.
Go to http://bit.ly/1errX1P
(Video courtesy of IOPtima)
“The microperforations did not affect the
safety or efficacy of the surgical outcome and
might even have improved filtration,” Dr. Anisimova said.
Data from 3 years of follow-up in a multicenter
study of CLASS show its safety benefits relative to trabeculectomy. The multicenter study
included 108 CLASS procedures and their outcomes were compared with a historical control
cohort of 105 eyes that underwent trabeculectomy. CLASS was associated with 36% fewer
complications (50% versus 86.7%), 33% less
vision loss, and 39% fewer cases of cataract
development. ■
Svetlana aniSimova, mD, PhD
Dr. Anisimova has no relevant fnancial interest to disclose.
Study: Complementary, alternative
medicines show no beneft, nor harm
By Cheryl guttman Krader
bALt iMore ::
COmplementary and alternative medicine (CAM) is a multibillion dollar industry in
the United States. However, when it comes to
glaucoma, it appears CAM use is modest and
mostly benign, but backed by little evidence
of efficacy, said Derek S. Welsbie, MD, PhD.
The National Center for Complementary and
Alternative Medicine of the National Institutes
of Health estimates that Americans are spending $34 billion a year on CAM. However, studies
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of glaucoma patients seen at university-based
practices in the United States and Canada found
only 5% and 14% of participants, respectively,
were using CAM for their disease, noted Dr.
Welsbie, assistant professor of ophthalmology,
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.
Across the two studies, megavitamins/antioxidants, bilberry, gingko biloba, carrots, and a
topical formulation of n-acetylcarnosine (Bright
Eyes) were the most commonly reported CAM
agents being used. A PubMed search for evidence about the efficacy of the most frequently
used CAM agents reveals little to no support
that they provide any benefit.
“There is a little data in favor of bilberry
use for glaucoma, but clearly more needs to
be done,” Dr. Welsbie said. He similarly concluded there has been no further evidence that
gingko biloba is neuroprotective to retinal ganglion cells, and results from two small glaucoma studies produced conflicting results. ■
ES557304_OT020115_035.pgs 01.22.2015 02:30
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Special Report )
SurgicAl And clinicAl mAnAgement of
Glaucoma
Bimatoprost adherence, persistence
superior in prior latanoprost users
Large, retrospective observational study reaffrms advantages of optimized formulation
By Cheryl Guttman Krader; Reviewed by Gail F. Schwartz, MD
Balt imore ::
Both adherence and persistence
and June 30, 2012 and had previously filled at least
1 prescription for generic or branded latanoprost.
All of those patients were included in the persistence analysis, and 8,740 (bimatoprost 0.01% n =
6,035; bimatoprost 0.03% n = 2,705) were included
in adherence and treatment status analyses based
on having 12 months of continuous post-index pharmacy benefit eligibility.
with glaucoma medication among prior latanoprost users are better among patients prescribed
branded bimatoprost 0.01% (Lumigan 0.01%,
Allergan) compared with bimatoprost 0.03%,
according to results from a real-world study.
“Bimatoprost 0.01% (Lumigan 0.01%, Allergan) was developed to provide more efficient
drug delivery and reduce hyperemia and disPDC DefineD
comfort as compared with its predecessor bima- Adherence to the index bimatoprost treatment
toprost 0.03% (Lumigan 0.03%, was defined as the proportion of days covered
Allergan), and a study com- (PDC) with study medication during the 365
paring the two branded for- days following the initial fill date. There were
mulations showed that they statistically significant differences favoring bihad equivalent efficacy, but matoprost 0.01% over the 0.03% formulation for
Lumigan 0.01% was associated both mean adherence (PDC = 0.74 versus 0.68)
with a significantly lower rate and median adherence (PDC = 0.88 versus 0.75).
Dr. Schwartz
of adverse events,” said Gail
In addition, there were statistically significant
F. Schwartz, MD, of Glaucoma Consultants, differences favoring the bimatoprost 0.01% coGreater Baltimore Medical Center.
hort over the 0.03% group for having a higher
“Bimatoprost 0.03% is now available as a ge- proportion of patients considered to have high
neric, and with the obvious needs for health care- adherence (PDC ≥0.80, 55.2% versus 48.7%)
cost containment, many providers or patients are and a lower proportion of patients with low
seeking generics,” added Dr. Schwartz, who is adherence (PDC ≤0.20 6.7% versus 10.8%).
also assistant professor, Wilmer Eye Institute,
“In an adjusted analysis, patients in the bimaJohns Hopkins University, Baltimore.
toprost 0.01% cohort were 30% more likely than
Previous studies comparing 0.03% and 0.01% those in the bimatoprost 0.03% cohort to have
bimatoprost formulations reported
high adherence and 41% less likely
better adherence and persistence
to have low adherence,” she said.
rates with the 0.01% branded prodAnalyses investigating proportions
uct, which is important over the
of patients remaining on their index
long-term because it should transprescription each month over the 12Adherence and
late into more consistent IOP con- persistence among
month, follow-up period showed the
trol. The current study corroborates patients prescribed
rate was higher in the bimatoprost
findings of the earlier studies in a bimatoprost 0.03% or
0.01% group than in the bimatoprost
larger patient population and by bimatoprost 0.01%
0.03% group beginning by the third
focusing on previous latanoprost was investigated using
month. At month 12, there was a
users who may be less likely to ex- pharmacy claims data,
statistically significant difference
perience tolerability issues relating and the results showed
between groups with 72.5% of pato conjunctival hyperemia.
tients who started on bimatoprost
statistically signifcant
Data for the retrospective, obser- differences favoring
0.01% remaining on that treatment,
vational study was extracted from bimatoprost 0.01%.
compared with 53.6% of those in the
the Longitudinal Rx Database from
bimatoprost 0.03% group.
IMS Health for a 3-year period beginning in July
Patients were considered persistent if they
2010. It included 11,234 adults who filled at least refilled their prescription within 30 days after
one prescription for bimatoprost 0.01% (n = 7,780) completing their existing days’ supply. At month
or bimatoprost 0.03% (n = 3,454) between Jan. 1 12, the proportion of patients showing persis-
take-home
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‘Adherence with
glaucoma therapy is
a chronic challenge.
Clinicians need to
consider tolerability
[with] prescription
decisions.’
— Gail F. Schwartz, MD
tence was significantly higher in the bimatoprost 0.01% cohort compared with the bimatoprost 0.03% group (52.7% versus 46.2%)
Subgroup analyses of adherence and persistence rates with patients categorized by age
(<65 and ≥65) consistently demonstrated significant differences favoring bimatoprost 0.01%.
“Adherence with glaucoma therapy is a chronic
challenge. Clinicians need to consider tolerability
when making prescription decisions for their patients,” she said. “Several studies show that 40%
of Americans prescribed glaucoma medications
cannot consistently take one drop a day. Hyperemia and/or irritation are among the most common reasons for poor adherence and persistence.”
Study authors acknowledged the research
has limitations, as it could not control for clinical imbalances between the bimatoprost 0.01%
and bimatoprost 0.03% cohorts, could not account for any samples that may have been provided, and presumed that prescription refills
were taken with perfect adherence, which may
not have occurred. ■
Gail F. Schwartz, MD
Dr. Schwartz is a consultant/advisor to and receives lecture fees/grant support from
Allergan.
ES557817_OT020115_036.pgs 01.22.2015 21:55
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Current Concepts in
Ophthalmology
Presented by
The Wilmer Eye Institute
Topics :
The Wilmer Eye Institute’s 32nd Annual
Current Concepts in Ophthalmology
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Practice Management
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Descemet’s Stripping
and Descemet’s Membrane
Endothelial Keratoplasty
Walter J. Stark, MD and Neil M. Bressler, MD
Vail,
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March 15-20, 2015
Vail Marriott
Supported by:
Mark Your Calendar!
The Wilmer Eye Institute's 28th Annual
Current Concepts in Ophthalmology
Special Features:
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December 3-5, 2015
•
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Johns Hopkins University School of Medicine
Thomas B. Turner Building
Baltimore, Maryland
June 19, 2015
Call (410) 502-9634 for more information
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For further information, please contact:
Office of Continuing Medical Education
Johns
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P: (410) 502-9634
F: (866) 510-7088
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ES558010_OT020115_037_FP.pgs 01.23.2015 00:41
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38
Special Report )
SurgIcAL And cLInIcAL mAnAgemenT Of
Glaucoma
Computer-guided treatment delivery
builds on benefts of SLT therapy
Pattern scanning laser trabeculoplasty offers comparable effcacy, potential advantages
By Cheryl Guttman Krader; Reviewed by Kaweh Mansouri, MD, and Miho Nozaki, MD, PhD
Results of a RetRospective
PSLT and SLT groups were also similar in their
chart review based on 6 months of follow-up mean baseline IOP (21.8 and 23.8 mm Hg, redemonstrate that pattern scanning laser tra- spectively) and mean number of medications
beculoplasty (PSLT) performed with a 577-nm used daily (2.7 and 3.1, respectively).
SLT was performed with a 532-nm laser (Tango
laser (PASCAL Streamline 577, Topcon Medical
Laser Systems) and computer-guided scanning Ophthalmic Laser, Ellex). All eyes were treated
technology is as effective as selective laser tra- for 360°. In the PSLT group, the average numbeculoplasty (SLT) for reducing IOP in patients ber of spots delivered was 1277 and the average
with open-angle glaucoma, according to Miho exposure energy was 1.7 mJ. In the SLT group,
the average number of spots delivered was 88
Nozaki, MD, PhD.
“Like SLT, PSLT minimizes thermal injury to and the average exposure energy was 0.8 mJ.
At 6 months, mean IOP was reduced to 14.3
the trabecular meshwork, but with the computerguided spot delivery, PSLT assures complete mm Hg (-33%) in the PSLT group and to 17.3
treatment without overlap or mm Hg (-21%) in the SLT group; the differgaps,” said Dr. Nozaki, associ- ence between groups in percentage of IOP reate professor of ophthalmology duction was not statistically significant. There
and visual science, Nagoya City were also no significant differences between
University Graduate School of the PSLT and SLT groups at 6 months in mean
Medical Sciences, Japan. “It medication use or the cumulative survival rate,
was initially developed using a although at 7 months, 3 SLT-treated eyes unDr. Nozaki
532-nm laser (PASCAL stream- derwent additional glaucoma surgery.
One eye in each group developed a tranline, Topcon Medical Laser Systems), and more
recently, the scanning software became avail- sient IOP elevation (>5 mm Hg). No eyes developed peripheral anterior synable for the yellow wavelength,
echia or showed corneal endothe577-nm laser.
lial cell loss.
“The results of this retrospective review support the efficacy
of PSLT with the 577-nm laser,”
PSLT v er SuS SLT
Pattern scanning
Dr. Nozaki said. “Now, a larger laser trabeculoplasty
Kaweh Mansouri, MD, consultant
prospective, controlled study is uses computer
ophthalmologist, Department of
required to verify the extent and guidance for precise
Ophthalmology, University of Gedurability of the IOP reduction.”
neva, Switzerland, and adjoint asdelivery of laser spots
In PSLT, the computer-guided to the trabecular
sociate professor
scanning technology sequentially meshwork. At 6 months
of ophthalmology,
delivers the treatment pattern onto post-treatment,
University of Colthe trabecular meshwork. After de- percentage IOP
orado School of
livering a set of spots, the aiming reduction was similar
Medicine, Aurora,
beam automatically rotates so that in eyes undergoing
is currently conthe next pattern of spots is pre- PSLT performed with a
ducting a randomDr. Mansouri
cisely aligned and applied onto an 577-nm laser compared ized trial comparuntreated location.
ing PSLT and SLT. The study is
with selective laser
The retrospective study included trabeculoplasty using a
enrolling patients with bilateral
24 eyes of 21 patients. There were 532-nm laser.
open-angle glaucoma who will be
12 eyes each in the PSLT and SLT
randomly assigned to receive PSLT
groups and no significant differor SLT in one eye and the alternate
ences between groups in demographic char- intervention contralaterally.
acteristics. The majority of patients in both
“Data available so far show that both PSLT
groups had primary open-angle glaucoma. The and SLT reduce IOP by about 25% to 30%. Based
take-home
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TrEaTmEnT wITh PSLT
VIDEO After application of a treatment
pattern, the scanning system automatically
rotated it and projected a new pattern with the
aiming beam. Go to http://bit.ly/1BfIaHe
(Video courtesy of Miho Nozaki, MD, PhD)
on the magnitude of response, I refer to their
benefit as a ‘laser prostaglandin effect.’ Since
the computer-guided treatment mode ensures
complete and regular treatment of the entire
trabecular meshwork, PSLT theoretically may
provide better outcomes than SLT in terms of
greater IOP lowering and/or better long-term
control,” he said.
“That remains to be seen, but our study is
designed so that each patient serves as his or
her own control and will enroll enough patients
so that it will have sufficient power to detect
any difference in treatment efficacy,” he said.
Dr. Mansouri’s study is also investigating
patient comfort during treatment using visual
analogue scale ratings. He noted that the data
collected so far indicate that when it comes
to tolerability, patients clearly prefer PSLT to
SLT. Dr. Mansouri added there is also a need
for data on re-treatment with PSLT. ■
Kaweh Mansouri, MD
Miho nozaKi, MD, PhD
Neither Dr. Nozaki nor Dr. Mansouri has any relevant fnancial interest to disclose.
ES558019_OT020115_038.pgs 01.23.2015 00:48
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39
Special Report )
SurgicAl And clinicAl MAnAgeMent oF
Glaucoma
Pseudoexfoliation syndrome risk:
Update on utility of genetic testing
LOXL1 gene associated with PXF, but clinical exams still the gold standard for detection
By Vanessa caceres; Reviewed by John H. Fingert, MD, PhD
Iowa CI t y, Ia ::
Pseudoexfoliation (Pxf) syndrome does not yet have a reliable genetic test
and is actually the result of multiple genetic
and environmental factors, said John H. Fingert, MD, PhD.
PXF is heritable, but it has a complex genetic basis.
“No one thing causes the disease on its own,”
said Dr. Fingert, associate professor of ophthalmology and visual sciences, University of
Iowa Carver College of Medicine, Iowa City.
There is one gene that’s confirmed as a risk
factor for PXF, the LOXL1 gene, he explained.
“This gene increases the risk for pseudoexfoliation, but testing cannot reliably predict
who will get the disease,” he said.
Key Points for PXF Genetics
1. PXF is heritable — caused in part by genes
2. Many factors act in concert to cause PXF
> No single factor can cause PXF on its own
3. LOXL1 is the only known genetic risk factor for PXF
> Testing for LOXL1 does not reliably predict who will develop PXF
> Most LOXL1 carriers never develop PXF
> Diagnostic testing of LOXL1 is not currently warranted for PXF
Source: John H. Fingert, MD, PhD
Understanding PXF
The original studies investigated Icelandic
syndrome
and Swedish populations, but subsequent rePrevious research involving identical twins search has included other patient populations.
showed that PXF is heritable, according to Dr.
“In all cases, LOXL1 is always a big risk facFingert.
tor,” he said. “However, all the risk variants
There are also commonly seen
are extremely common.”
cases of PXF that cluster within
This has led to some unusual
families, again demonstrating the
findings about the gene. For examfamilial connection. Even animal
ple, the risk allele G153D is found
studies of inbred laboratory mice
in about 88% of the normal SwedAlthough the
show that PXF can be passed from
ish population without PXF, yet it
LOXL1 gene may
generation to generation.
is also found in 100% of patients
The disease also appears to be increase the risk for
with PXF.
more prominent in certain ethnic pseudoexfoliation
This is why genetic testing has
groups, such as Scandinavian pop- syndrome, currently
been so difficult, he explained.
ulations. In contrast, the disease available genetic
“Currently, there’s no clinical
is much more rare in populations, testing does not
utility in the diagnosis of PXF in
such as Eskimos. However, none effectively predict who
testing for LOXL1 and the value of
of these findings seems to point will develop disease.
testing is limited to research purto an exact cause of PXF.
poses,” Dr. Fingert said.
“It occurs because of the combined effects
“However, large collaborative genetic studof many genetic and environmental factors, ies are underway that will likely find more geand no single factor can determine which of netic factors,” he added.
our patients will develop pseudoexfoliation,”
Dr. Fingert said.
how t o coU nsel Pat ie n t s
Progress has been made toward a better unwith PXF
derstanding of the environmental factors that Dr. Fingert concluded by explaining what he imcontribute to PXF, such as latitude and ultra- parts to patients with PXF about their condition.
violet exposure.
“I tell them it is a heritable condition caused
A breakthrough in the understanding of PXF in part by genes, but currently we don’t know
came in 2007, with the finding of LOXL1 as the most of those genes. So, testing is not very usefirst known genetic factor, Dr. Fingert said.1
ful now,” he said. “I also tell them the current
take-home
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best way to diagnose is a careful exam in an
ophthalmology clinic.”
Dr. Fingert cited recommendations from the
American Academy of Ophthalmology on genetic testing, which state that testing should
be avoided until studies have demonstrated a
benefit to patients who have tested positive.2
“This is clearly a benchmark not yet met
for the LOXL1 gene or PXF,” he concluded. ■
References
1. Thorleifsson G, Magnusson KP, Sulem P, et al.
Common sequence variants in the LOXL1 gene confer
susceptibility to exfoliation glaucoma. Science.
2007;317:1397-400.
2. Stone EM, Aldave AJ, Drack AV, et al.
Recommendations for genetic testing of inherited
eye diseases: report of the American Academy
of Ophthalmology task force on genetic testing.
Ophthalmology. 2012;119:2408-2410.
John h. Fingert, MD, PhD
This article was adapted from Dr. Fingert’s presentation during Glaucoma Subspecialty
Day at the 2014 American Academy of Ophthalmology. He did not indicate any
proprietary interest in the subject matter.
ES557362_OT020115_039.pgs 01.22.2015 02:46
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40
Special Report )
SurGical aNd cliNical maNaGemeNT of
Glaucoma
Bubble formation during SLT may be
an indicator of excessive energy
Adjusting treatment parameters by lowering energy levels an effective solution
By Brian A. francis, MD, Ms, Special to Ophthalmology Times
and utilize techniques to locate the trabecular meshwork properly.
Other tissues may be mistaken for a pigtreatment endpoint of selective laser trabeculoplasty (SLT)—is now a marker of the tis- mented trabecular meshwork.
If the angle is narrow, then a pigmented
sue’s reaction to an unnecessarily high-energy
pulse, which can result in complications like Schwalbe’s line may be mistaken for the traelevated IOP and long-term inflammation, becular meshwork. Treating the cornea by
mistake may cause inflammation in the cordiscomfort, and scarring.
Cavitation energy bubbles that form in the nea or corneal edema.
If a patient has a narrow angle, use comaqueous during SLT indicate that tissue is abpression gonioscopy at the slit lamp to desorbing the laser.
However, once these bubbles develop, it may termine the angles structures. Compression
be an indicator that too much energy is being gonioscopy opens up the angle further to
view the full width of the angle.
transferred to the tissue.
If the angle is deep or wide open without
much pigmentation, a ciliary body band may
A new A pproAch
Fol low i n g re s ea rch publ i she d by t he be mistaken for the trabecular meshwork.
Treating the ciliary body causes
Journal of Glaucoma, there is a
inflammation and pain—neither
new tendency to adjust laser (Seof which is effective clinically in
lecta II SLT, Lumenis) parameters
terms of lowering IOP.
so that the energy and the spot
A technique can be used by
size have decreased.
The adjustment of
having the patient look toward the
Previously, where recommen- treatment parameters
mirror of the gonio lens, which
dations were to perform 100 spots may be an effective
is referred to as “looking over
over 360° of the meshwork with technique for
the hill”—in other words, lookhigher energy, clinicians are now surgeons to avoid
ing over the iris into the angle
performing about 150 spots that bubble formation
to see the trabecular meshwork
are slightly overlapping but with during selective laser
more easily.
much less energy.
trabeculoplasty.
Viewing the angle inferiorly can
The hope is that more of the
avoid mistaking the ciliary body
trabecular meshwork is reached
while keeping the energy level low to pre- band for the trabecular meshwork, because
it will often reveal pigment in trabecular
vent IOP spikes.1-2
Overall, the same amount of total en- meshwork that is not evident when looking
ergy is applied to the eye but decreasing at the superior angle.
the amount per burst and increasing the
r esolution
number of spots. Clinicians are applying
of issue
more energy to the right tissue at more apIn the event too much energy is applied, sevpropriate energy levels.
In the past, it would not be unusual to use eral steps can be taken to decrease inflammaa 1.0 energy setting, but now clinicians are tion. Begin the patient on nonsteroidal antistarting at 0.5. Highly pigmented eyes with inflammatory drops or a short dose of topipigmentary discersion glaucoma or exfoliation cal steroids.
Also, be careful to detect IOP spikes in paglaucoma are more likely to develop bubbles
because the tissue absorbs energy more eas- tients who might have received too much enily. In these patients, consider starting at an ergy. Check IOP an hour later and, perhaps,
even check it again that day, and at 1 day and
even lower energy level.
It is critical to assess the angle structures 1 week or more frequently if necessary.
Los AngeL es ::
surgIcal VIDEO
BuBBle formation—formerly a
take-home
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VIDEO surgeons need to be mindful of
the amount of energy applied during sLT to avoid
bubble formation. go to http://bit.ly/1yJGPNo
(Video courtesy of Brian A. Francis, MD, MS)
conclusion
SLT is a safe and effective initial therapy for
patients with open-angle glaucoma or ocular hypertension. However, excessive energy—indicated by bubble formation—causes
a higher incidence of elevated IOP, as well as
long-term inflammation and discomfort and
scarring of the angles.
Adjusting treatment parameters by lowering energy levels is an effective solution. ■
References
1. Katz LJ, Steinmann WC, Kabir A, et al; SLT/Med Study
Group. Selective laser trabeculoplasty versus medical
therapy as initial treatment of glaucoma: a prospective,
randomized trial. J Glaucoma. 2012;21:460-468.
2. Alvarado JA, Katz LJ, Trivedi S, et al. Arch Ophthalmol.
2010;128:731-737.
Brian a. Francis, MD, Ms, is the holder of the Ralph and
Angelyn Riffenburgh Professorship in Glaucoma and an associate
professor of ophthalmology at USC Eye Institute, Keck School of
Medicine in Los Angeles. He did not indicate any proprietary interest
in the subject matter. Dr. Francis may be reached at 323/442-6415 or bfrancis@
doheny.org
ES558261_OT020115_040.pgs 01.23.2015 02:48
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CAREERS
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RETINA
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Ochsner Health System is southeast Louisiana’s largest non-profit, academic,
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ES558265_OT020115_042_CL.pgs 01.23.2015 03:03
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CAREERS
LA
MARYLAND
OCULOPLASTICS-ONCOLOGIST
Ochsner Health System in New Orleans is seeking a Board Certified
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Medicine and The University of Queensland Medical School in Brisbane,
Australia. Clinical research is encouraged.
Ochsner Health System is southeast Louisiana’s largest non-profit, academic,
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Heal, Lead, Educate and Innovate, coordinated clinical and hospital patient
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ES558267_OT020115_043_CL.pgs 01.23.2015 03:03
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practice management
44
Every clinic has ‘characters';
how to manage them is key
No matter the practice, there will always be bullies, divas, and ‘that guy’ on staff
Putting it in View By Dianna e. Graves, cOMT, Bs ed
I
t’s easy to get lulled into believing that
the issues we face daily are unique to
only our office—that we are the only
managers in the world who deal with
staff and physician concerns like ours.
If you look around, it will become abundantly clear: Every office has the same characters, curmudgeons and souls as you do.
You simply have to observe how they go
about their day and it becomes glaringly
clear.
I recently went with a friend to have new
tires put on the car. We went to a tire store
that we were sure was going to relieve the
perils of another Minnesota winter by replacing the treadless tires with new tires
that would handle loose pavement, snow,
and all assortments of road peril. Utilizing
their super road hugger, efficient tires, you
could almost see in small print, “You’re safe
with our tires, little lady!,” written on the
side of each tire.
The casT is seT
Our first encounter was with “John Wayne.”
While we were quietly pricing and comparing tire brands, he sauntered up to us,
smiled a grandfatherly grin (he was all of 28
years old) and said, “Can I help you, young
ladies, today?”
If he had been wearing a Stetson, I am
positive he would have tugged on the brim
of the hat and nodded his head.
In our office, we call this person “the
Schmoozer.”
The Schmoozer—best described as the
one feigning extreme interest—comes across
as over fawning and is ingratiating to a
fault. Someone who after three minutes, you
want to escape but very often cannot.
It’s an Oscar-award winning performance,
but the care that is provided is subpar at
best.
Now, in Minnesota, we have a saying
when something needs to be done: “Well, if
I were going to (insert the chore), I’d get ‘a
guy’ to do it.”
magenta
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Or, for a question about plumbing, we
A very attentive controller sat us down to
would say: “Well, a guy would put another
discuss tire pressure, when to rotate, the difelbow in there and it will flow better.”
ference between plain air versus nitrogen
Not that it has to be a male, but it’s just
when filling tires.
a phrase that is used regarding everything
She was officious, and even though she
that needs fixing.
had obviously been through this discus‘The guy’ is never named,
sion a million times, she lisbut evidently it is a tried-andtened well, allowed questrue saying, so I responded to
tions, and answered them in
Understanding that
Mr. Wayne by saying:
people talk. We understood
every offce will have
“We are looking to talk to
what she was telling us and
varying personalities
a guy about tires.”
promised to comply to ensure
and characters is
He beamed his largest
happy, safe tires.
important when
smile and said, “It’s your
While my friend was setmanaging staff
lucky day. I’m your guy.”
tling the bill, I thought about
members.
After 20 minutes of torour office and how we aptuous bartering, we agreed
peared to others. I soon reto the tires he was recomalized that not only did we
mended–not because we had faith in them,
have the same cast of characters, we had a
but more to move along with the process.
few more morphed into multiple roles!
Having sealed the deal, he quickly called
another "other guy," who was going to be
clinic ch a r acTer s
the tire installer.
John Wayne: We had “the guy” who was
Enter “Elvis.”
going to take care of the whole process and
He swaggered into the lobby wearing
make sure you were taken care of before
a gleaming outfit, including a clean, red
he dumped you on someone else. He was
grease rag hanging from his pocket. The
very willing to show us the tires, etc., until
towel was grease-free.
the front door clanged and the next sale enWe were placed in the bullpen area where
tered. When this occurred, we were quickly
we could watch the tires going onto the car.
and obviously moved along to the next atIt is then that I saw why he was so clean.
tendant in line.
Elvis was the office diva. He was the lead
This occurs in offices when staff—who
over the grease-smeared worker bees who
are kind, patient, and helpful so they can
were working on the car.
get their portion done—quickly move to the
He watched as the two assistants renext person in line or looking to buy glasses,
moved the snow-covered tires, put the new
etc. when another sale hits their view.
ones on the rims, and balanced and aligned
As for Elvis: I have more than a few divas.
the whole group. He did this with a watchThe key to divas is twofold:
ful eye as he sipped his coffee and recorded
> Get them to understand they are a diva,
their progress on a clipboard.
With the car still on the lift, Elvis put
and that at times this may not be a popular
on gloves and checked each tire pressure,
role for them.
> Get others to realize that yes, this person
marked it suitable on his clipboard, and determined the job was done to his approval.
is a diva, and why would anyone in their right
The final stop was with mission control—
mind want to be them?
time to ensure all systems were a go for
departure.
Continues on page 46 : Characters
Take-Home
ES558294_OT020115_044.pgs 01.23.2015 03:31
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45
practice management
Is your practice mindful of patients'
time in regard to visits, phone calls?
Clinicians should be attentive and responsive through proper communications
Practice Management issues By Frank J. Weinstock, MD, Facs
Editor’s note: With this
issue, Ophthalmology
Times begins a new
practice management
column, called Practice Management Issues, that will address
many of the common
problems that most
Dr. Weinstock
physicians experience
in their practices. Many of these problems
can be resolved with simple solutions. The
editor of the column is Frank J. Weinstock,
MD, FACS, who also has written many books
on practice management.
P
atients are people. They usually
are not confrontational and do not
like to complain to authority (the
physician or the office manager).
Before they decide to go elsewhere
for their eye care, they will more than likely
complain to friends and family. Their usual
comment is “Dr. X is a wonderful ophthalmologist, but I hate to go to his office.”
Patients arrive to the office on time, then
wait one to two hours before they are called
back to the exam lanes. Routinely, when patients inquire about how long they will have
to wait, the stock answer from the staff is:
“The doctor will be with you shortly.”
cOncer n, cOMMunicaTiOn
How does a practice remedy the long waiting time? First, you must be concerned
and communicate it to the staff. Physicians
should watch or “visit” the reception area
periodically to see if there is a “crowd.”
Look at the scheduled times for patients and
monitor this regularly. Of course, the physician also should get to the office a little
early and be ready to see the first patient
when he or she is ready.
It is also important to communicate to the
staff (through words and actions) that you
would like to be on time. If the physician does
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black
his or her part, the staff will make it happen.
If the physician is late, he or she should apologize to the patient. If the physician is sincere, patients will usually accept this. The
physicians also should make a note to be sure
to see a patient on time with the next visit.
Recognizing that the physician and staff
do patient testing and have several appointments at the same time, there is always a little waiting after the patient is brought into
the exam lane. Patients appreciate that the
staff is concerned with their time.
PhOne calls an issue?
Do you or your office staff answer phone
calls in a timely manner. Patients want a
physician who is accessible.
Patients realize that physicians are seeing
other patients or in surgery, but the practice should not accept this as an excuse.
Although seemingly insignificant to physicians and staff, a question may be very
stressful for the patient.
Many offices place the phone on an answering machine for most of the day. Most physicians probably are unaware of this practice.
The staff will use the answering machine
at noon and at the end of the day–often the
staff will stop receiving calls 15 to 30 minutes before phone calls should be held and
start 15 to 30 minutes after the set starting
time in the morning or after lunch.
Although this is convenient for the staff,
concerned and apprehensive patients may
go to the ER, to another physician, or simply be upset with the physician (since they
assume the physician sets the policies) in
these situations. The physician or office
manager should call the office to see how
the staff handles calls. Or they can listen to
them in the office to find out how the staff
responds to patients.
A patient with a question is sometimes referred to a non-physician in the office, who
may be unable to answer the question adequately, and basically says the physician is
not available. There should be a logical policy to answer the concerns of patients.
Another scenario is a patient who needs
a copy of his or her records and is told that
he or she must come into the office to sign a
form. These records could easily be mailed
or faxed to the patient.
Think of the patient’s reaction if he or she
lives a distance from the office, or has a handicap and has difficulty making it to the office.
The practice should show compassion by mailing or faxing a form to be signed and returned.
Whether it’s a patient call with a question, or just a call for a prescription refill,
the practice should never have set times to
receive and respond to phone calls. Patients
may be only available to call at certain
times, and they should not expect return
calls after 5 p.m. or the next day. The practice should feel for an anxious patient and
one will see that this is not acceptable.
aDDressinG r x reFills
In regard to prescription refills, it is not unusual for the staff to say that they will take
care of it “in time,” but not give any indication of when.
Patients also should learn the results of
laboratory tests as soon as possible. They
become more anxious as each day goes by
without hearing from the office. Practices
should develop a system whereby patients
receive their results in a timely manner.
At all times, the practice should be honest
with patients and be compassionate in communicating back to them. It is not uncommon to hear that patients may have stayed
home all day waiting for a return call from
the practice–or for their prescription to be
called in–only to call again in the morning,
and get the same answers as the day before.
Patients will put up with these policies
for only so long before they switch to a more
responsive ophthalmologist.
Bottom line is: Demonstrate to your patients that you care and be responsive to
them. ■
For more information, visit Dr. Weinstock's website: www.drfrankweinstock.com.
Readers also may contact Dr. Weinstock via e-mail at: [email protected]
ES558295_OT020115_045.pgs 01.23.2015 03:31
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46
practice management
CHaRaCTeRS
Divas need to be watched as they often
can turn into bullies if they are not getting
the recognition they seek. They can drift in
and out of this role and when they morph
into the bully role, they can become periodically disruptive to the rest of the clinic.
We also have bullies. The key to bullies
can be hard to figure out, but primarily it is
this:
You need to let them know you are onto
their routine, and since you are their manager, you are up for the challenge. Bullies do
not like to be backed into a corner because
they lose the upper hand.
Bullies are one of the hardest types of
staff to control in your office. They create a
chaos that is hard to rectify, as they often
prey on another’s insecurities and these are
often hidden by the staff being preyed upon.
Bullies know their prey’s weakness and
will attack them when they have the opportunity, or simply because they are bored and
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are looking for a little excitement. When a
bully is on the prowl, make sure you counter equally and swiftly. They need to be
aware you are onto their behavior and will
not tolerate it–no matter what their rank is
in your clinic.
As I have mentioned in the past, bullies are often in an elevated position, a position of presumed power because of their
role with the doctor. Many people, even the
managers, will avoid confronting them because they feel the doctor will protect them.
When this is the case in a practice, there is
not much a manager can do.
TalK WiTh The PhYsician
What you need to do in this case is to talk
with the doctor, letting him or her know the
impact this person (by using the doctors
stature and cover) is doing to the rest of the
staff. You need the doctor’s assistance to get
this situation handled quickly.
Lastly, you have "mission control." These
are the "go-to folks" in your office that listen, follow through, and do everything they
can to ensure that the patient receives an
excellent experience. They usually are the
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AcrySof® IQ ReSTOR® IOLs.
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in individuals with the AcrySof® Natural
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in subjects with hereditary color vision
defects and acquired color vision defects
secondary to ocular disease (e.g.,
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uveitis, and other retinal or optic nerve
diseases) has not been studied. Do not
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ATTENTION: Reference the Directions
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indications, warnings and precautions.
worker bees in each role (front desk, technicians, and optical) that do their job everyday with minimal fanfare.
Here I was in the tire shop watching
“my staff,” but the only difference was the
uniforms.
That Monday, I went to the office and
watched a morning of encounters with patients. Later that afternoon, I sat down and
listed who was what character and then
pondered what to do with this behavior.
After a bit, I realized that there wasn’t
much to do about it except the following:
Be sure that these various roles were wellbalanced and insulated between the worker
bees and the go-to people in the office. To
ensure I was on the right track, I went online to see what a guy might say about this.
The response was a referral to the tire
store where I had spent my Saturday! ■
DIaNNa e. GRaVeS, ComT, BS eD, is clinical services
manager at St. Paul Eye Clinic PA, Woodbury, MN. Graves is a
graduate of the School of Ophthalmic Medical Technology, St. Paul,
MN, and has been a member of its teaching faculty since 1983. She
can be reached at [email protected].
Advertiser Index
Advertiser
Page
Advertiser
Alcon Laboratories Inc.,
CV2,
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46, CV4
ICare USA
P: 800/862-5266
www.alcon.com
NovaBay Pharmaceuticals
4A–B
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7-8, 21-22, 27-28
P: 714/246-4500 or
800/433-8871 (Customer Service)
F: 714/246-4971
www.allergan.com
Bausch + Lomb
ThromboGenics
31
25
P: 732/590-2900
www.thrombogenics.com
Wilmer Eye Institute
37
P: 410/502-9635
www.HopkinsCME.edu
17-18
P: 800/227-1427 or
800/323-0000 (Customer Service)
www.bausch.com
Glaukos
CV3
www.icare-usa.com
www.novabay.com
Alimera Sciences
Allergan Inc.
Page
This index is provided
as an additional service.
The publisher does not assume
any liability for errors or omissions.
11
P: 800/452-8567
www.glaukos.com
OPHTHALMOLOGY TIMES (Print ISSN 0193-032X, Digital ISSN 2150-7333) is published semimonthly except for one issue in August and
December (22 issues yearly) by UBM Advanstar, 131 W First Street, Duluth, MN 55802-2065. Subscription rates: $200 for one year in
the United States & Possessions, Canada and Mexico; all other countries $263 for one year. Pricing includes air-expedited service. Single
copies (prepaid only): $13 in the United States & Possessions, Canada and Mexico; $20 all other countries. Back issues, if available are $25
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paid at Duluth, MN 55806 and additional mailing offices. POSTMASTER: Please send address changes to OPHTHALMOLOGY TIMES, P.O.
Box 6009, Duluth, MN 55806-6009. Canadian G.S.T. number: R-124213133RT001, Publications Mail Agreement Number 40612608.
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© 2013 Novartis 9/13 RES13076JAD
©2015 Advanstar Communications Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form
or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval without permission in
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beyond those listed above, please direct your written request to Permission Dept. fax 440-756-5255 or email: [email protected].
ES558293_OT020115_046.pgs 01.23.2015 03:31
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E asy to obtain IOP’s on your most difficult patients
VISIT THE ICARE BOOTH AT:
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San Francisco, CA
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Coronado, CA
LEARN MORE:
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icare-usa.com
ES557982_OT020115_CV3_FP.pgs 01.23.2015 00:40
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ES558014_OT020115_CV4_FP.pgs 01.23.2015 00:42
ADV

MIGS: Expanding realm of glaucoma

Transcription

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