CTR does not prevent IOL dislocation

Transcription

Cutting-edge Advancements
Clinical Diagnosis
OphthalmologyTimes.com
follow us online:
Surgery
cataract surgery:
From routine
to custom plan
Surgery
July 1, 2015 Vol. 40, No. 11
Drug therapy
CTR does not prevent
IOL dislocation
Large series also shows device appears to ease
repositioning of capsular bag-IOL complex
IN VIEW
YOUR PATIENTS’ VISION
IS ONLY AS GOOD AS
THE IOL YOU CHOOSE.
Here is an
example of
in-the-bag IOL
dislocation
with “evident”
pseudoexfoliation.
Jacksonvill e, F L :: In this first
of a three-part series, Arun C. Gulani,
MD, discusses the concept and approach to designing primary cataract surgery. Each patient deserves
not only the best surgery performed
using the best technology, but also a
designed concept to meet the visual
requirements tailored to each case
individually, he notes.
(Photo courtesy of Betty
Lorente, MD)
( See story on page 8 : Gloves Off )
Don’t just leave a lens. Leave a legacy.
Clinical Diagnosis
pinpointing cause
of unexplained
vision loss
Learn how on page 5.
By Cheryl Guttman Krader;
or at the University Hospital Complex of A Coruña,
Coruña, Spain.
Reviewed by Betty Lorente, MD
“In-the-bag IOL dislocation that occurs spontaneMiami :: autoimmune retinopathy
ously
many years after uneventful cataract surgery
may not be that common, but cliniis
the
result of progressive zonular dehiscence,”
Barcelona, Spain ::
cians should keep the diagnosis in
said
Dr.
Lorente, fourth-year resident, Centro de
Implantation of a capsular
mind when a patient presents with
Oftalmología
Barraquer, Barcelona, Spain.
tension
ring
(CTR)
at
the
time
of
cataract
surgery
unexplained visual loss, explained
Some
authors
advocate using a CTR in all cases
does
not
prevent
spontaneous
in-the-bag
IOL
disByron L. Lam, MD. Autoimmune retto
prevent
this
event,
but the role of CTR is conlocation
or
affect
the
outcome
of
surgical
repair
if
inopathy is separated into three diftroversial
as
published
reports document that inthat
complication
occurs.
ferent categories, including: paranethe-bag
IOL
dislocation
also occurs in eyes with
However,
the
presence
of
a
CTR
does
appear
to
oplastic retinopathy, which includes
a
CTR,
Dr.
Lorente
noted.
facilitate
repositioning
of
the
capsular
bag-IOL
comrecoverin-associated retinopathy and
“Our study, which represents the largest series
plex, according to research undertaken by Betty
melanoma-associated retinopathy;
of
in-the-bag IOL dislocation reported to date,
Lorente,
MD,
and
colleagues.
non-paraneoplastic autoimmune retishows
that the presence of a CTR in the capsular
The
investigators
analyzed
data
for
105
cases
of
nopathy; and combined paraneoplas© tic
2015
Abbott
Medical
Optics
Inc.
|
www.AbbottMedicalOptics.com
|
PP2015CT0510
bag
does
not prevent IOL dislocation,” Dr. Lorin-the-bag
IOL
dislocation
and
compared
the
preoptic neuropathy and retinopathy.
ente
explained.
sentation
characteristics
and
surgical
outcomes
“There are many other yet undefined
Eyes included in the study were identified through
for 84 eyes that had no CTR and 21 eyes with a
causes we don’t know about yet,” aca
retrospective
search of the surgical database for
CTR.
All
surgeries
were
performed
at
the
Univercording to Dr. Lam.
the
years
2005
to
2009 or were part of a prospecsity
Hospital
Complex
of
Ourense,
Ourense,
Spain,
( See story on page 30 : Autoimmune )
( Continues on page 15 : Dislocation )
CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
OphthalmologyTimes.com
FOLLOW US ONLINE:
Surgery
CATARACT SURGERY:
FROM ROUTINE
TO CUSTOM PLAN
SURGERY
July 1, 2015 VOL. 40, NO. 11
DRUG THERAPY
CTR does not prevent
IOL dislocation
Large series also shows device appears to ease
repositioning of capsular bag-IOL complex
IN VIEW
Here is an
example of
in-the-bag IOL
dislocation
with “evident”
pseudoexfoliation.
JACKSONVIL L E, F L :: IN THIS FIRST
of a three-part series, Arun C. Gulani,
MD, discusses the concept and approach to designing primary cataract surgery. Each patient deserves
not only the best surgery performed
using the best technology, but also a
designed concept to meet the visual
requirements tailored to each case
individually, he notes.
(Photo courtesy of Betty
Lorente, MD)
( See story on page 8 : Gloves Off )
Clinical Diagnosis
PINPOINTING CAUSE
OF UNEXPLAINED
VISION LOSS
MIAMI :: AUTOIMMUNE retinopathy
may not be that common, but clinicians should keep the diagnosis in
mind when a patient presents with
unexplained visual loss, explained
Byron L. Lam, MD. Autoimmune retinopathy is separated into three different categories, including: paraneoplastic retinopathy, which includes
recoverin-associated retinopathy and
melanoma-associated retinopathy;
non-paraneoplastic autoimmune retinopathy; and combined paraneoplastic optic neuropathy and retinopathy.
“There are many other yet undefined
causes we don’t know about yet,” according to Dr. Lam.
( See story on page 30 : Autoimmune )
By Cheryl Guttman Krader;
Reviewed by Betty Lorente, MD
BARCELONA, SPAIN ::
IMPLANTATION OF A CAPSULAR
tension ring (CTR) at the time of cataract surgery
does not prevent spontaneous in-the-bag IOL dislocation or affect the outcome of surgical repair if
that complication occurs.
However, the presence of a CTR does appear to
facilitate repositioning of the capsular bag-IOL complex, according to research undertaken by Betty
Lorente, MD, and colleagues.
The investigators analyzed data for 105 cases of
in-the-bag IOL dislocation and compared the presentation characteristics and surgical outcomes
for 84 eyes that had no CTR and 21 eyes with a
CTR. All surgeries were performed at the University Hospital Complex of Ourense, Ourense, Spain,
or at the University Hospital Complex of A Coruña,
Coruña, Spain.
“In-the-bag IOL dislocation that occurs spontaneously many years after uneventful cataract surgery
is the result of progressive zonular dehiscence,”
said Dr. Lorente, fourth-year resident, Centro de
Oftalmología Barraquer, Barcelona, Spain.
Some authors advocate using a CTR in all cases
to prevent this event, but the role of CTR is controversial as published reports document that inthe-bag IOL dislocation also occurs in eyes with
a CTR, Dr. Lorente noted.
“Our study, which represents the largest series
of in-the-bag IOL dislocation reported to date,
shows that the presence of a CTR in the capsular
bag does not prevent IOL dislocation,” Dr. Lorente explained.
Eyes included in the study were identified through
a retrospective search of the surgical database for
the years 2005 to 2009 or were part of a prospec( Continues on page 15 : Dislocation )
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©2015 Abbott Medical Optics Inc. iLASIK, iDESIGN, iDESIGN Advanced WaveScan Studio, WaveScan, and STAR S4 IR are trademarks owned
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JULY 1, 2015 :: Ophthalmology Times
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8 DESIGNING PRIMARY
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First of three-part series discusses
surgery tailored to needs of each case
Special Section
16 INFORMED DECISIONS:
WEIGHING FEMTO FACTORS
Knowledge of parameters helps surgeons
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Clinical Diagnosis
30 AUTOIMMUNE RETINOPATHY:
UNEXPLAINED VISION LOSS
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testing can help pinpoint etiology
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INDICATIONS: The STAR S4 IR Excimer Laser
and iDESIGN Advanced WaveScan Studio System is
indicated for wavefrontguided LASIK in patients with
myopia as measured by iDESIGN System up to -11.00 D
SE, with up to -5.00 D cylinder; with agreement between
manifest refraction (adjusted for optical infinity) and
iDESIGN System refraction of 1) SE: magnitude of the
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33 WHEN CLINIC STAFF
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In This Issue
4 EDITORIAL
6 LETTERS
31 MARKETPLACE
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4
editorial
JULY 1, 2015 ◾ VOL. 40, NO. 11
CONTENT
Follow the money
EyeMDs second to hematologists/oncologists in Medicare dollars
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]
I DIDN’T DECIDE to go to medical
school in order to make a lot of money. Rather,
my purpose in attending medical school was to
help people.
If it were money I was after, I would have
done what normal people who lust after ungodly amounts of wealth do—become an official for Fédération Internationale de Football
Association (FIFA).
So, it makes me slightly embarrassed to read
articles with titles like, “Some doctors reap outsize share of Medicare payments,” and learn that
ophthalmologists are second only to hematologists/oncologists in terms of receiving Medicare
dollars.
Medical oncologists come in a distant third,
followed by cardiologists at number four,
and radiation oncologists in the number-five
position.
Given that it is easier to find a cardiologist or
radiation oncologist who is not wealthy than it
is to find one of former Secretary of State Hillary Clinton’s e-mails, I can only presume my
neighbors and acquaintances will see these
news reports and suspect that I am:
> Wealthy;
> Motivated to be an ophthalmologist by something
oncologists top the list, as well as the lamentable truth that among ophthalmologists, these
tax dollars flow disproportionately to retina
specialists who inject costly anti-vascular endothelial growth factor agents into the vitreous cavities of patients with greater frequency
than President Bill Clinton can give $500,000
speeches. Only 20% of the payments are for
exams and evaluations, while the next largest
chunk (14%) is for surgeries and procedures.
WHAT WENT WRONG?
My initial reaction—being as competitive in nature as any other former medical student—is to
wonder where I went wrong, such that neither
I nor my group of cornea/external disease colleagues are anywhere near the top of the list.
At first blush, this kind of thing does for
one’s ego what Tom Brady’s locker room assistant does for his footballs. If people are going
to suspect me of being motivated by greed,
shouldn’t I at least be obscenely wealthy and
spending my free time clubbing with other
über-rich people like Jay-Z and Bill Gates?
But perhaps being a failure—stuck among
the less productive 99% of my fellow physicians—is not all that bad.
Some of the practices of the 1% have drawn
scrutiny from regulators and prosecutors. The
No. 3 biller among individual providers in 2013
was Salomon E. Melgen, MD, a Florida ophthalmologist who had close ties to Sen. Robert
Menendez (D-NJ) and was indicted on healthfraud charges in April.
Although the article doesn’t mention it, so
was the senator. ■
Chief Medical Editor Peter J. McDonnell, MD
Group Content Director Mark L. Dlugoss
[email protected] 440/891-2703
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Money Matters John J. Grande, Traudy F. Grande, and
John S. Grande, CFPs®
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
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other than altruism.
T O P 1% G A R N E R 7 5%
One thing that is interesting about the Medicare data is how much goes to the top 1% of
physician billers. They garnered 17.5% of Medicare payments in 2013, after receiving 16.6% in
2012. So these “one percenters” sure seem busy,
and one wonders whether they have achieved
the ideal work-life balance.
As the data breakdown shows, most (51%)
of the payments consist of reimbursements for
medications. That would logically explain why
magenta
cyan
yellow
black
Reference
• Some doctors reap outsize share of Medicare payments.
Wall Street Journal. June 2, 2015.
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As a female ophthalmologist who owns my
own practice and employs three female eye
doctors (one MD, two ODs), I found a recent editorial by Peter J. McDonnell, MD,
interesting (http://bit.ly/1IGk8KJ).
The concept of an equally “productive
colleague” is challenging. Doctors can have
similar training and skills and yet, their contributions can make one more valuable in
both money as well as intangible qualities.
Obviously, I am very supportive of women
physicians or I would not hire them. I am
supportive of the five maternity leaves
we have had over a 6-year period. As you
know, the loss on income is very tangible
as the overhead marches on. But I believe
in women working and I believe in family, so
I am willing to endure that financial loss.
But let us be honest. That is a real monetary issue. It is also true that whether
male or female, some doctors simply are
more productive and more conducive to
the ease of running the practice.
In a small practice, a single owner is
well aware of every time a doctor wants to
change a schedule or is not happy and wants
things done differently. It is human nature
to reward those who not only contribute the
most financially, but equally important, make
the work environment positive. Our pay is
for “the job” but also for our role in “the
play.” How well does that employed doctor
fit with their counterparts? And how much
do they contribute to the smooth running
of the practice, and therefore, the psychological well-being of all who work there?
It’s nice to think everything comes down
to collections, and maybe in academic departments or large practices that is the
case. But in small practices, the value of
an employed doctor has a more nuanced
definition, at least for me.
That is where negotiation comes into play.
It allows me as a boss to interact with the
employed doctor based both on numbers
and those intangibles I feel they bring to the
table. I believe anyone of any persuasion
should be paid equally for equal work. All
I am saying is it isn’t all so clear cut that
the work is equal whether it be between
male and female or female and female.
Kim Wise, MD
Wise Eye Associates
Norman, OK
FINDING INSPIRATION AMONG SOLITUDE
A recent editorial on Ignaz Semmelweis
(http://bit.ly/1LRo27i) by Peter J. McDonnell, MD, reminded me of a poem I was
inspired to write a few years ago.
By way of explanation, at the time, we
lived on an old hilltop farm just outside
Louisville, KY. Up by the long dried-up
well were the remains of a log cabin my
mother used to visit as a teenager back
in the “Roaring Twenties.” One sunny day,
as spring was falsely approaching, I saw
a solitary daffodil blooming in the former
dooryard. For some reason, it brought to
mind another first that I have marveled
over throughout my long ophthalmology
career, and inspired this ode:
THE FIRST DAFFODIL
The first daffodil, a solitary, joyous thing,
arrived quite early last week, declaiming
the emergence of spring.
Standing alone, ahead of its brothers, it
brought to my mind the solitude of others.
In our profession, only a few have chosen such a path, and for their efforts, oft
received their peers’ wrath.
It takes self-belief and large measures
of courage, as year after year, their ideas
they nourish.
Harold Ridley, MD, was just such a man.
For advancing eye surgery, he took such
a stand.
Following cataract operations, people
wore Coke-Bottle glasses, ’til Dr. Ridley
sought better sight for these masses.
He used a glass lens to replace the cataract, and was shunned universally for this
“criminal” act.
Through many long years he gamely persevered, and finally, now, he’s properly revered.
In today’s operation, it is no longer drastic,
all people receive new implants of plastic.
A few years ago, his sleights were all
righted.
Sir Harold, by the Queen, was even
beknighted.
Standing alone is oft hard to swallow,
but, as the first daffodil knows, in time
others follow.
John Distler, MD
Bluegrass Eye Center
Louisville, KY
Letters to the Editor may be submitted to [email protected].
Letters may be edited for clarity and length.
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2015 :: Ophthalmology Times
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8
surgery
Designer cataract surgery
concept tailored to each case
‘Premium’ cataract surgery is not necessarily ‘custom’ cataract surgery
Gloves Off with Gulani By Arun C. Gulani, MD
Editor’s Note: This is the first of a threepart column that will address the concept
and approach to designing primary cataract surgery. The two subsequent columns
will address staged cataract surgery in complex cases and correcting premium cataract surgery complications.
s in previous columns, I always
like to start with the mindset.
Though cataract surgery is
considered to be one of the most
routinely performed procedure
in all of medicine—with millions of cases performed annually—this very concept of a routine surgery
is abhorrent.
I believe that cataract surgery is an oppor(FIGURE 1) Mindset for designing cataract surgery. (Photos courtesy of Arun C. Gulani, MD)
tunity for surgeons to enable patients to have
the best sight possible for the rest of their life.
Because no cataract surgery should be considered routine, each patient deserves not only the ment with my rhetoric: “Cataract and what ing options from the available array of treatbest surgery performed using the best tech- else”? What I am trying to drive home is a ments (Gulani 3T system) to resolve all of
nology, but also a designed concept to meet point that whenever we see a patient with a each patient’s conditions during one surgery
their visual requirements that is tailored to cataract we must ask ourselves “What else?” that they need anyway, i.e., cataract surgery.
is associated with it.
each case individually.
By not doing so, a surgeon will have missed
This single statement will cause a paradigm out on the only opportunity that individual
This column is the first of three in which I
will share with colleagues the concept and ap- shift in our mindset that the industry has spent patients had for the rest of their lives.
proach to designing primary cataract surgery. millions of dollars on in trying to configure
With such an outlook, I encourage colleagues
premium cataract surgery.
The two subsequent columns
to classify every cataract patient into four catI teach my fellows with an egories and then individually plan to address
will address staged cataract suranalogy to the game of bowling. all of their correctable visual issues (bowling
gery in complex cases and corFirst pick all the pins, i.e., asso- pins) using custom designed cataract surgery.
recting premium cataract surIn the first of a
ciated ammetropia, presbyopia,
gery complications.
three-part series,
pathology, etc., and then aim The Gulani Cataract Category Classification
In my attempt to always emArun C. Gulani, MD,
for a strike. To have two pins comprises four categories:
power colleagues, I would like
discusses the concept
> Cataracts with associated refractive errors
standing at the end of a throw
at the outset also to clarify that
and approach to
could be human error, mistake,
beyond a certain necessity, tech(i.e., myopia, hyperopia, astigmatism, and
designing primary
or complication but to not aim
nology is an added benefit, not
presbyopia);
cataract surgery.
> Cataracts with a previous eye surgery (i.e.,
to strike is unacceptable!
a crutch upon which to become
This leads us into my four
dependent in the pursuit of perRK, LASIK, etc.);
> Cataracts with an associated pathology (i.e.,
categories of cataract presentations
fect vision.
The surgeon’s first consideration is deterThe most important statement I shall make
Fuchs disease, corneal scar, keratoconus etc.) and
> Enhancement of a previous cataract surgery
in this column is what I ask my fellows and mining the associated pathologies, ammetrovisiting surgeons when they tell me that a cer- pias, past ocular surgical history, and visual
(i.e., residual ammetropia, haloes, glare, etc.)
tain patient has a cataract. I follow that state- dysfunctions of each patient and then choosContinues on page 10 : Designing
A
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PROLENSA®
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Available in a 3-mL bottle size
PROLENSA® delivers potency and corneal penetration
with QD efficacy1,2
1-3
1,4
INDICATIONS AND USAGE
PROLENSA® (bromfenac ophthalmic solution) 0.07% is a nonsteroidal anti-inflammatory drug (NSAID)
indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who
have undergone cataract surgery.
IMPORTANT SAFETY INFORMATION ABOUT PROLENSA®
Warnings and Precautions
.*"0)""' ') %$(
."%,%'"-" $
.%)$) "%''%((($( ) + ).$'(" $%%*"') ((*(
.%'$")( $"* $!') ) (
.%$))"$(,'
Adverse Reactions
The most commonly reported adverse reactions
in 3%-8% of patients were anterior chamber
$1##) %$%' $%-($() %$-& $
&%)%&% $"*''+ ( %$
Please see brief summary of Prescribing Information on adjacent page.
References: 1. PROLENSA® Prescribing Information, April 2013. 2. Data on file, Bausch & Lomb Incorporated. 3. Baklayan GA, Patterson HM,
Song CK, Gow JA, McNamara TR. 24-hour evaluation of the ocular distribution of 14C-labeled bromfenac following topical instillation into the
eyes of New Zealand White rabbits. J Ocul Pharmacol Ther. 2008;24(4):392-398. 4. BROMDAY® Prescribing Information, October 2012.
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2015 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. US/PRA/15/0015
10
surgery
DESIGNING
( Continued from page 8 )
When all of these factors are considered
for individual patients, the surgical plan unfolds clearly.
For example, a Category 1 cataract patient
may wear bifocal glasses for farsightedness,
astigmatism, and presbyopia. Therefore, there
are four visual factors affected—cataract, farsightedness, astigmatism, and presbyopia. Instead of considering such a patient as a routine case and rushing them through a cataract
surgery assembly line, the surgeon should try
PROLENSA® (bromfenac ophthalmic solution) 0.07%
Brief Summary
PROLENSA® (bromfenac ophthalmic solution) 0.07% is indicated for the
treatment of postoperative inflammation and reduction of ocular pain in
patients who have undergone cataract surgery.
PROLENSA® ophthalmic solution following cataract surgery include:
anterior chamber inflammation, foreign body sensation, eye pain,
photophobia and vision blurred. These reactions were reported in 3 to
8% of patients.
USE IN SPECIFIC POPULATIONS
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 quantification) 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.
WARNINGS AND PRECAUTIONS
There are no adequate and well-controlled studies in pregnant women.
Sulfite Allergic Reactions
Because animal reproduction studies are not always predictive of
Contains sodium sulfite, a sulfite 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 benefit justifies the potential risk to the fetus.
asthmatic episodes in certain susceptible people. The overall prevalence
Because of the known effects of prostaglandin biosynthesisof sulfite sensitivity in the general population is unknown and probably
inhibiting drugs on the fetal cardiovascular system (closure of ductus
low. Sulfite 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-inflammatory 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 efficacy 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 efficacy or safety profiles 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
NONCLINICAL TOXICOLOGY
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 quantification) 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 significant 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
with complicated ocular surgeries, corneal denervation, corneal epithelial PATIENT COUNSELING INFORMATION
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
Sterility
of Dropper Tip
become sight threatening. Topical NSAIDs should be used with caution
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
Rx Only
Clinical Trial Experience
Manufactured by: Bausch & Lomb Incorporated, Tampa, FL 33637
Because clinical trials are conducted under widely varying conditions,
Under license from:
adverse reaction rates observed in the clinical trials of a drug cannot be
Senju Pharmaceuticals Co., Ltd.
directly compared to rates in the clinical trials of another drug and may
Osaka, Japan 541-0046
not reflect the rates observed in clinical practice.
Prolensa is a trademark of Bausch & Lomb Incorporated or its affiliates.
The most commonly reported adverse reactions following use of
© Bausch & Lomb Incorporated.
9317600
US/PRA/14/0024
DOSAGE AND ADMINISTRATION
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 first 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.
to correct all of the patient’s visual problems
during one cataract surgery.
Category 2 patients who have undergone
previous refractive surgeries such as LASIK
and RK may present with either long-term
side effects of those surgeries with gradually
decreasing vision over time or a need for an
enhancement. Their vision can be planned
using cataract surgery with specific new technology lens implants including incision sealants and intraoperative calculation technology
to be followed by staged, laser vision surgery
for excellent visual outcomes.
For Category 3 patients who have an associated pathology, such as keratoconus, corneal scars, or Fuchs dystrophy besides cataracts, the surgeon can plan for the visual
endpoint by first manipulating the optics of
the eye using new technology IOLs with cataract surgery to prepare for laser Corneoplastique techniques.
Finally, Category 4 patients with previous
cataract surgery may have the wrong IOL power/
technology in place or a surgical complica-
Technology
(FIGURE 2) A variety of technologies are available
for ophthalmologists to access when designing
cataract surgery.
surgery
11
Technique
Quantification of the densitometry
Camera/slit position and image
Reflex at the
Bowman layer
Objective
quantification in
the chosen point
Basis for
quantification is
the grey scale of
the image,
standardize
from 0 to 100.
(FIGURE 3) Various techniques that
an eye surgeon utilize singly and in
while designing cataract surgery.
tion or may want an enhancement of their
cataract surgery. In such cases, the surgeon
should plan to exchange the lens implant or
piggyback or perform corneal refractive surgery to correct not only their resultant spectacle prescription but also resolution of the
offending symptoms.
CUSTOM PLANNING,
CUSTOMIZED VISION
This four-category classification allows surgeons
to place practically every cataract case into a
plan mode and then work toward the Gulani
3-T system: target, technology, and technique,
when designing a customized cataract surgery
plan. I spend extensive time with every patient
determined to find my pins
Success Criteria:
and to confirm their visual
1. Pupil Size (Mesopic and Scotopic)
3. Q Factor
target. We can then work
2. Corneal Asphericity
4. Pupil-IOL centration
on how to deliver that tar(FIGURE 4) Diagnostic criteria essential for designing cataract surgery.
get based on their clinical
status from the 3-T system
to the four-category classification to see how the plan unfolds.
focal, multifocal, toric, accommodating, or
TARGET. The surgeon first determines the dual IOLs; the cataract extraction technology:
patient’s customized visual goals of monovi- femtosecond laser/phacoemulsification; insion, blend, progressive, or accommodative traoperative aberrometry measurement sysvision and any professional requirements, for tems, combinations such as LASIK laser viexample, for pilots and night vision-depen- sion surgery/diamond astigmatic incisions;
and two- or three-dimensional visualization
dent professions.
TECHNOLOGY. The technologies to be con- systems including the recently FDA-approved
sidered are the type of lens implant: monoContinues on page 12 : Custom
12
surgery
Beyond Refraction: Spherical Aberration
RK-CAT-Undilating,
Festooned Pupil with Iris
Hooks and Toric IOL
Toric IOL in
keratoconus
Spherical Aberration:
Cornea +ve, Lens –ve and with
age –ve decreases (Haloes,
Glare, Night Vision)
Tecnis: Induces negative
Crystalens: Neutral
ReStor: Induces Positive
Aspheric: Neutral
(FIGURE 7) Complex cases simplified with a
focused plan toward 20/20 vision.
RK-AK-Cat:
Toric IOL (20/40 to 20/20)
(FIGURE 5) Spherical aberration
measurement in selecting
premium lens technology and also
understanding poor outcomes.
OCT — Pseudo hole and ERM
(FIGURE 6) Determining posterior segment, retina, and ocular status in understanding the limits of best
vision potential.
CUSTOM
incision sealants. In addition, combined knowledge about the technologies and the optics of
the eye allow measurement of higher order aberrations along with secondary refractive errors and optical zones with corneal aspheric-
ity, which are factors that affect vision beyond
the three common refractive errors.
TECHNIQUE . The surgical technique could
be based on cataract densitometry analysis,
associated pathologies, and planned correctables dependent on incision site placement and
energy applications.
Armed with this information, the surgeon
can then dedicate a plan personalized to each
patient. Rather than being intimidated by technology or its indispensability, one can confi-
(FIGURE 8) RK patients with relatively good
vision but negatively impacted lifestyles deserve
our intention to obtain excellent vision. Note
here an artist with preop vision of 20/40 (not so
bad vision) who needed to be brought to 20/20
with good contrast.
dently pick the technology most applicable in
each case from a shelf (in our mind) as we
determine the target and technique for that
case remembering all the time that for that
particular patient this surgery will impact the
rest of his or her life.
Continues on page 14 : Technique
Cornea. Capsule. Lens.
One optimized solution.
Shown with the VERION™ Digital Marker
Demand precision across the entire anterior segment.
Part of The Cataract Refractive Suite by Alcon, the LenSx® Laser is designed
to optimize performance across the entire anterior segment to deliver:
• Precise primary and
secondary corneal incisions,
and arcuate incisions
• Complete, reproducible
capsulotomies with
pristine edges1
• Versatile fragmentation
patterns
1. Alcon data on file.
Visit LenSxLasers.com, or talk to your local Alcon
representative about how the LenSx® Laser can help
enhance the precision of cataract surgery with AcrySof® IOLs.
© 2014 Novartis 11/14 LSX14078JAD
magenta
cyan
yellow
black
COMPLE TE PRECISION
ES634316_OT070115_013_FP.pgs 06.25.2015 02:37
ADV
14
surgery
TECHNIQUE
Thus, rather than forcing a set technology
and technique on all patients, imagine the
fun of picking specific technologies such as
femtosecond laser in cases of mature white
cataracts or nystagmus, incision sealants in
RK cases, toric or accommodative lens implants previous refractive or corneal irregularity cases, and then even combination technologies to design each case to achieve its
best vision potential.
Though one cannot guarantee outcomes
ACRYSOF® IQ INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION
CAUTION: FEDERAL USA LAW RESTRICTS THIS DEVICE TO THE SALE BY OR ON THE ORDER OF A PHYSICIAN.
in every case, one can surely guarantee the
attempt to perfect each and every case. This
mindset will make every cataract surgery a
pleasure and raise the bar from routine assembly line medicine to focused, customtailored surgery with a payback that is beyond measure.
In the next part of this three-part column,
I will review cataract surgery as a planned
optical manipulation in a staged, combination concept to correct complex cases in designing vision. ■
INDICATIONS: THE ACRYSOF® IQ POSTERIOR CHAMBER INTRAOCULAR LENS IS INTENDED FOR THE REPLACEMENT OF THE HUMAN LENS TO
ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THIS LENS IS INTENDED FOR PLACEMENT IN
THE CAPSULAR BAG.
CASE EXAMPLES
WARNINGS/PRECAUTIONS: CAREFUL PREOPERATIVE EVALUATION AND SOUND CLINICAL JUDGMENT SHOULD BE USED BY THE SURGEON TO
DECIDE THE RISK/BENEFIT RATIO BEFORE IMPLANTING A LENS IN A PATIENT WITH ANY OF THE CONDITIONS DESCRIBED IN THE DIRECTIONS FOR
USE LABELING. CAUTION SHOULD BE USED PRIOR TO LENS ENCAPSULATION TO AVOID LENS DECENTRATIONS OR DISLOCATIONS.
STUDIES HAVE SHOWN THAT COLOR VISION DISCRIMINATION IS NOT ADVERSELY AFFECTED IN INDIVIDUALS WITH THE ACRYSOF® NATURAL IOL
AND NORMAL COLOR VISION. THE EFFECT ON VISION OF THE ACRYSOF® NATURAL IOL IN SUBJECTS WITH HEREDITARY COLOR VISION DEFECTS AND
ACQUIRED COLOR VISION DEFECTS SECONDARY TO OCULAR DISEASE E.G., GLAUCOMA, DIABETIC RETINOPATHY, CHRONIC UVEITIS, AND OTHER
RETINAL OR OPTIC NERVE DISEASES HAS NOT BEEN STUDIED. DO NOT RESTERILIZE; DO NOT STORE OVER 45° C; USE ONLY STERILE IRRIGATING
SOLUTIONS SUCH AS BSS® OR BSS PLUS® STERILE INTRAOCULAR IRRIGATING SOLUTIONS.
ATTENTION: REFERENCE THE DIRECTIONS FOR USE LABELING FOR A COMPLETE LISTING OF INDICATIONS, WARNINGS AND PRECAUTIONS.
LENSX® LASER IMPORTANT PRODUCT INFORMATION
CAUTION: UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE AND USE BY OR ON THE ORDER OF A PHYSICIAN OR LICENSED EYE
CARE PRACTITIONER.
INDICATION: THE LENSX® LASER IS INDICATED FOR USE IN PATIENTS UNDERGOING CATARACT SURGERY FOR REMOVAL OF THE CRYSTALLINE
LENS. INTENDED USES IN CATARACT SURGERY INCLUDE ANTERIOR CAPSULOTOMY, PHACOFRAGMENTATION, AND THE CREATION OF SINGLE
PLANE AND MULTIPLANE ARC CUTS/INCISIONS IN THE CORNEA, EACH OF WHICH MAY BE PERFORMED EITHER INDIVIDUALLY OR CONSECUTIVELY
DURING THE SAME PROCEDURE.
RESTRICTIONS: PATIENTS MUST BE ABLE TO LIE FLAT AND MOTIONLESS IN A SUPINE POSITION. PATIENT MUST BE ABLE TO UNDERSTAND AND
GIVE AN INFORMED CONSENT. PATIENTS MUST BE ABLE TO TOLERATE LOCAL OR TOPICAL ANESTHESIA. PATIENTS WITH ELEVATED IOP SHOULD USE
TOPICAL STEROIDS ONLY UNDER CLOSE MEDICAL SUPERVISION.
CONTRAINDICATIONS: CORNEAL DISEASE THAT PRECLUDES APPLANATION OF THE CORNEA OR TRANSMISSION OF LASER LIGHT AT 1030
NM WAVELENGTH. DESCEMETOCELE WITH IMPENDING CORNEAL RUPTURE. PRESENCE OF BLOOD OR OTHER MATERIAL IN THE ANTERIOR
CHAMBER. POORLY DILATING PUPIL, SUCH THAT THE IRIS IS NOT PERIPHERAL TO THE INTENDED DIAMETER FOR THE CAPSULOTOMY. CONDITIONS
WHICH WOULD CAUSE INADEQUATE CLEARANCE BETWEEN THE INTENDED CAPSULOTOMY DEPTH AND THE ENDOTHELIUM APPLICABLE TO
CAPSULOTOMY ONLY. PREVIOUS CORNEAL INCISIONS THAT MIGHT PROVIDE A POTENTIAL SPACE INTO WHICH THE GAS PRODUCED BY THE
PROCEDURE CAN ESCAPE. CORNEAL THICKNESS REQUIREMENTS THAT ARE BEYOND THE RANGE OF THE SYSTEM. CORNEAL OPACITY THAT WOULD
INTERFERE WITH THE LASER BEAM. HYPOTONY OR THE PRESENCE OF A CORNEAL IMPLANT. RESIDUAL, RECURRENT, ACTIVE OCULAR OR EYELID
DISEASE, INCLUDING ANY CORNEAL ABNORMALITY FOR EXAMPLE, RECURRENT CORNEAL EROSION, SEVERE BASEMENT MEMBRANE DISEASE.
HISTORY OF LENS OR ZONULAR INSTABILITY. ANY CONTRAINDICATION TO CATARACT OR KERATOPLASTY. THIS DEVICE IS NOT INTENDED FOR USE
IN PEDIATRIC SURGERY.
WARNINGS: THE LENSX® LASER SYSTEM SHOULD ONLY BE OPERATED BY A PHYSICIAN TRAINED IN ITS USE.
THE LENSX® LASER DELIVERY SYSTEM EMPLOYS ONE STERILE DISPOSABLE LENSX® LASER PATIENT INTERFACE CONSISTING OF AN APPLANATION
LENS AND SUCTION RING. THE PATIENT INTERFACE IS INTENDED FOR SINGLE USE ONLY. THE DISPOSABLES USED IN CONJUNCTION WITH ALCON®
INSTRUMENT PRODUCTS CONSTITUTE A COMPLETE SURGICAL SYSTEM. USE OF DISPOSABLES OTHER THAN THOSE MANUFACTURED BY ALCON
MAY AFFECT SYSTEM PERFORMANCE AND CREATE POTENTIAL HAZARDS.
THE PHYSICIAN SHOULD BASE PATIENT SELECTION CRITERIA ON PROFESSIONAL EXPERIENCE, PUBLISHED LITERATURE, AND EDUCATIONAL
COURSES. ADULT PATIENTS SHOULD BE SCHEDULED TO UNDERGO CATARACT EXTRACTION.
PRECAUTIONS: DO NOT USE CELL PHONES OR PAGERS OF ANY KIND IN THE SAME ROOM AS THE LENSX® LASER. DISCARD USED PATIENT
INTERFACES AS MEDICAL WASTE.
AES/COMPLICATIONS: CAPSULOTOMY, PHACOFRAGMENTATION, OR CUT OR INCISION DECENTRATION. INCOMPLETE OR INTERRUPTED
CAPSULOTOMY, FRAGMENTATION, OR CORNEAL INCISION PROCEDURE. CAPSULAR TEAR. CORNEAL ABRASION OR DEFECT. PAIN. INFECTION.
BLEEDING. DAMAGE TO INTRAOCULAR STRUCTURES. ANTERIOR CHAMBER FLUID LEAKAGE, ANTERIOR CHAMBER COLLAPSE. ELEVATED PRESSURE
TO THE EYE.
VIDEOS Go to http://bit.ly/1JzZvpr
Go to http://bit.ly/1C2C1GC
Go to http://bit.ly/1T8g6Ck
Go to http://bit.ly/1CduTHV
Go to http://bit.ly/1HzCBy5
(Videos courtesy of Arun C. Gulani, MD)
References
1. Gulani AC. Corneoplastique: Art of LASIK and cataract
surgery. Ind J Ophthalmol. 2014;62:3-11.
2. Gulani AC. Evaluating the impact of femto laserassisted capsulotomy. Cataract and Refractive Surgery
Today Europe. 2014;9:36-50.
3. Gulani AC. Shaping the future and reshaping the past:
the art of vision surgery. Chapter 98. In: Copeland
and Afshari’s Principles and Practice of Cornea. New
Delhi, India: Jaypee Brothers Medical Publishers,
2013;2:1252-1273.
4. Donnenfeld E, Gulani AC. Astigmatism correction
during cataract surgery. In: Garg H, Alió JL, eds.
Femtosecond Laser: Techniques and Technology.
1st ed. Miami JayPee Highlights Medical Publishers;
2012;21:155-161.
5. Gulani, AC. Vision à la carte: Designing vision.
Ophthalmology Times. 2013;38:31-33.
6. Gulani AC. Corneoplastique. Techniques in
Ophthalmology 2007;5:11-20.
7. Gulani AC. Art of vision surgery. Video Journal of
Cataract and Refractive Surgery. 2006;XXII.
ATTENTION: REFER TO THE LENSX® LASER OPERATOR’S MANUAL FOR A COMPLETE LISTING OF INDICATIONS, WARNINGS AND PRECAUTIONS.
© 2014 Novartis 11/14 LSX14078JAD
ARUN C. GULANI, MD, is founding director and chief surgeon
of the Gulani Vision Institute, Jacksonville, FL. Dr. Gulani has no
financial interests to declare.
surgery
similar proportions of eyes with and without
a CTR (81.0% versus 72.6%).
“Our Northern part of Spain has one of
the highest rates of pseudo( Continued from page 1 )
exfoliation in Europe,” Dr.
Lorente said.
Glaucoma was the most
tive interventional case series operated on
common associated conduring the years 2010 to 2013.
The only significant difference found in dition, being present in 52
comparing presentation characteristics of the eyes (46%). Again, there
two study groups was that was no significant differthe IOL dislocation occurred ence in the prevalence of
significantly sooner after sur- glaucoma among eyes with
gery in eyes with a CTR than and those without a CTR
in those without, ~5 years (52% versus 42%).
Almost 75% of the disversus 8.7 years.
“We believe this finding located IOLs were acrylic,
Dr. Lorente
may be explained by the fact which corresponds with the
that a CTR was probably used at the time of fact that acrylic lenses are
surgery in the worst cases,” Dr. Lorente said. the most commonly used implants at the cenThere was no significant difference be- ters involved in the study.
Dislocation correction was done by repotween the CTR and no CTR groups in mean
age at the time of the IOL dislocation, 80.4 sitioning of the IOL in 49 eyes, of which 48
had ab externo scleral fixation. Another 49
versus 81.9 years.
The in-the-bag IOL dislocation was most eyes underwent IOL exchange for either an
anterior chamber IOL (29 eyes)
often categorized as grade III
or an iris-claw IOL (20 eyes).
(~60%; superior edge of the IOL
The proportion of eyes that
below the visual axis), while
underwent repositioning was
almost 33% of eyes had a grade
In what is believed
slightly higher in eyes with
II dislocation (superior edge of
to be the largest
a CTR than in those without.
the IOL above the visual axis).
reported series of
A grade III dislocation was
spontaneous in-theL O G M A R C DVA
the most common type in eyes
bag IOL dislocation,
BETTER
without a CTR, whereas a grade
investigators analyze
Mean
logMAR corrected disII dislocation was more compresenting charactertance
visual
acuity (CDVA) immon than a grade III dislocaistics and outcomes
proved
significantly
after intion in eyes with a CTR.
for 21 eyes with a
tervention,
and
was
not sigThe leading risk factor for
capsular tension ring
nificantly
different
comparing
IOL dislocation was pseudoex(CTR) and 84 eyes
eyes with and without a CTR.
foliation, which was present
without the device.
Final mean logMAR CDVA
in 78 (74%) eyes and affected
DISLOCATION
15
was slightly better in eyes with an iris claw
IOL than in both eyes with a scleral-fixated
IOL or those with an anterior chamber IOL
‘In-the-bag IOL dislocation
that occurs spontaneously
many years after uneventful
cataract surgery is the
result of progressive zonular
dehiscence.’ — Betty Lorente, MD
TAKE-HOME
(0.33 versus 0.42 and 0.47), although the between-group differences were not statistically
significant.
Not surprisingly, the types of complications encountered after intervention differed
by procedure.
Dr. Lorente acknowledged that the study
has limitations that are inherent to a retrospective design.
In addition, there was no standard protocol for CTR implantation in place at the participating centers, and comparisons between
the CTR and no CTR groups may have been
affected by their different sizes. ■
BETTY LORENTE, MD
E: [email protected]
This article was adapted from Dr. Lorente’s presentation during the 2014 meeting of
the American Academy of Ophthalmology. Dr. Lorente has no relevant financial interests
to disclose.
Bayer, Johns Hopkins forge alliance targeting retinal diseases
L E VERKUSEN, GERMAN Y ::
BAYER HealthCare and Johns Hopkins University School of Medicine, Baltimore, have
entered into a 5-year collaboration agreement
to develop new ophthalmic therapies targeting
retinal diseases, including age-related macular degeneration, diabetic macular edema,
geographic atrophy, Stargardt’s disease, and
retinal vein occlusion.
Bayer and Johns Hopkins’ Wilmer Eye Institute will jointly conduct research activities
evaluating new targets and disease mechanisms,
drug delivery technologies, and biomarkers
for diseases with high unmet medical need.
“Bayer is strongly committed to further expanding its research efforts in the area of retinal diseases,” said Andreas Busch, PhD, head
of Global Drug Discovery and member of the
Executive Committee of Bayer HealthCare. “The
Wilmer Eye Institute’s deep understanding of
eye disease biology and patient care and Bayer’s expertise in drug discovery and development in ophthalmology complement each
other perfectly.”
“There is a critical need for new therapies that
treat a variety of serious diseases of the eye,”
said Peter J. McDonnell, MD, director, Wilmer
Eye Institute; professor of ophthalmology, Johns
Hopkins University School of Medicine, and
chief medical editor of Ophthalmology Times.
“Additional research will allow us the opportunity to make significant advances in this area.”
Under the agreement, Bayer will have an
option for the exclusive use of the collaboration results. Financial terms of the agreement
were not disclosed. ■
16
ADVANCEMENTS IN
Special Report )
REFRACTIVE SURGERY
ADVANCES CONTINUE TO PROGRESS FOR IMPROVING AND ENHANCING THE REFRACTIVE STATE OF THE EYE
INFORMED DECISIONS: WEIGHING
FEMTOSECOND FEATURES, FACTORS
Knowledge of parameters helps physicians evaluate ideal platforms for their practices
By Cheryl Guttman Krader; Reviewed by Ronald R. Krueger, MD, MSE
U
CL E VEL AND ::
take-home
Femtosecond
lasers differ in their
indications, energy
delivery parameters,
and hardware
features. For surgeons
interested in acquiring
a laser, understanding
the implications of
these factors will
enable an objective
assessment of the
available technology.
nderstanding how hardware design and technical specifications
affect femtosecond laser performance provides surgeons with the
fundamental knowledge they need to evaluate the available systems
and choose one that will best fit their needs, according to Ronald
R. Krueger, MD, MSE.
Dr. Krueger discussed the implications of different
laser parameters and provided an overview of the features of commercially available femtosecond laser platforms. The latter are represented by systems used for
cornea/refractive applications only (IntraLase, Abbott
Medical Optics; WaveLight FS200, Alcon Laboratories;
Femto LDV Z4 and Z6, Ziemer; VisuMax, Carl Zeiss Meditec), cataract surgery only (LensAR, LensAR; Catalys,
Abbott Medical Optics), and units that can be used
for both cornea/refractive and cataract
procedures (LenSx, Alcon; Femto LDV
Z8, Ziemer; Victus, Bausch + Lomb).
(Note: Laser availability and approved
indications vary by country.)
“At the present time, the best lasers
for refractive procedures are those with
refractive-only optics and design, while
Dr. Krueger
the best lasers for cataract surgery have
cataract-only optics and design,” said Dr. Krueger, medical director, Department of Refractive Surgery, Cole Eye
Institute, Cleveland Clinic, Cleveland, OH.
“This is important to consider, as providers who seek
both a refractive and cataract laser might be tempted to
get one for both indications,” he said.
TECHNICAL ISSUES
Factors affecting energy delivery with femtosecond lasers include pulse duration, numerical aperture, and
wavelength. When it comes to pulse duration and wavelength, shorter is better, as both require less energy density for photodisruption.
Currently, surgeons do not have options when it comes
to laser wavelength since all femtosecond lasers use a
near infrared wavelength.
However, ultraviolet units, which would significantly
reduce the energy density needed for photodisruption,
may be available in the future, Dr. Krueger said.
In terms of numerical aperture, larger is preferable,
as it provides a tighter focus and thereby enables the
use of lower energy.
Pulse frequency (repetition rate) and pulse separation are other important variables in the performance
of femtosecond lasers. A higher pulse frequency may
allow for a shorter procedure time and/or a shortening
Spectrum of Corneal Femto-Lasers
Femtosecond Lasers for Refractive and Corneal Surgery
Technolas Perfect
Vision FEMTEC
Abbott Medical Optics Alcon Laboratories
iFS Laser
WaveLight FS200
Carl Zeiss Meditec
VisuMax
Ziemer
Femto LDV
500 kHz
20 MHz
40 kHz
150 kHz
200 kHz
500 to 700 fs
600 to 800 fs
350 fs
220 to 580 fs
200 to 350 fs
~1 uJ
~0.7 to 1 uJ
~0.5 to 0.8 uJ
~0.15 to 0.3 uJ
>0.03 uJ
Curved
Flat
Flat
Curved
Flat
Note: Laser availability and approved indications vary by country. (Table courtesy of Ronald R. Krueger, MD, MSE)
Special Report )
Special Report )
REFRACTIVE SURGERY
of pulse separation distance. The
latter is important for achieving
the desired tissue effect with lower
energies, which helps to minimize
collateral tissue damage and procedural side effects.
Of the femtosecond lasers used
for refractive surgery, the Femto
LDV stands out among the others by having the fastest pulse frequency (20 MHz versus 40 to 500
kHz) and the lowest pulse energy
(>0.03 uJ versus 0.15 to 1 uJ).
Nevertheless, the Femto LDV does
not have a benefit for shortening
procedure length since it delivers
pulses in an overlapping pattern,
said Dr. Krueger, who is also professor of ophthalmology, Cleveland
Clinic, Lerner College of Medicine,
Case Western Reserve University,
Cleveland, OH.
Femtosecond lasers also vary
with respect to clinical interfacing. The corneal laser platforms
have either a curved or flat interface, and there are pros and cons
for each type. A flat interface may
be technically easier to use than a
curved interface, but causes more
tissue deformation and IOP elevation. Although it has a flat interface,
the FS200 features an enhanced
suction ring design to minimize
IOP elevation.
A curved interface is more vulnerable to suction loss than a flat
interface, and makes the laser more
sensitive to centration issues, as x-y
adjustments after docking may be
limited. The latter issue, however,
is usually not a concern when the
laser is being used for flap creation.
The cataract femtosecond lasers
have either curved lens or fluid
interfaces. Dr. Krueger said that
fluid coupling, which is found on
the LensAR and Catalys lasers,
is a desirable feature for cataract
femtosecond lasers since it allows
for better intraocular imaging and
laser delivery without light scatter losses, thereby improving the
accuracy of treatments involving
the capsule and lens.
The laser pulse pattern, raster
versus spiral, also varies between
refractive lasers, and is usually determined by the type of coupling.
Lasers with a flat interface will
typically best deliver spots in a
raster pattern, whereas curved interface lasers typically work best
with a spiral delivery.
Corneal lasers can also be differentiated by whether or not they
have adaptations for evacuating
gas bubbles, which is important
to limit opaque bubble layer (OBL)
formation. The latter problem is
partially controlled by an intrastromal pocket to sequester gas
bubbles when using the IntraLase laser, and with an evacuation
canal for externalizing bubbles
when using the FS200.
Other lasers have not integrated
specific features for gas evacuation,
and while gas bubble build-up is
less of a problem with the lower
energy Femto LDV and VisuMax
lasers, it is not avoidable and may
still lead to undesirable OBL.
The cataract femtosecond lasers
all have image guidance systems
that are necessary for achieving
precise delivery of laser energy into
the eye to target tissues. Most of the
lasers use OCT, although posterior
imaging may be somewhat limited
with that technology. The LensAR
uses a proprietary 3-D “augmented
reality” imaging system that provides excellent detail. While all
cataract lasers have software to
compensate for astigmatism axis
alignment, the compensation for
lens tilt is better with the fluid interface lasers.
HIGH POINTS
Highlighting specific features of
the various lasers, Dr. Krueger said
the IntraLase stands out as the first
femtosecond laser and the current
market leader in the refractive surgery marketplace. The FS200 shares
many similarities with the IntraLase, although it is faster and causes
less increase in IOP because it uses
lower suction.
The Victus with curved coupling
was the first to offer both refracContinues on page 19 : Decisions
Technolog
LEADER
“Marco is focused on the next
generation of refractive technology
and process. With wavefront-assisted
refraction, you achieve a more
complete understanding of the total
visual system in a fraction of the time.
The goal is greater accuracy and more
data in less time resulting in greater
patient engagement and satisfaction.
Superior results and lasting impact on
patients simply drives greater revenue
– a real competitive advantage.”
David Marco | Jacksonville, FL
Designed and Manufactured by NIDEK - Represented by Marco
800-874-5274 " marco.com
18
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
SMILE offers promise for refractive
correction despite some limitations
Issues regarding irregular astigmatism, potential enhancements draw some concern
By Nancy Groves; Reviewed by Steven E. Wilson, MD
CL E VEL AND ::
SMALL-INCISION LENTICULE extraction (SMILE) is a promising new approach
for refractive correction but has its limitations as
currently performed, said Steven E. Wilson, MD.
During a SMILE procedure, the femtosecond
laser makes two lamellar passes across the cornea that intersect in the peripheral cornea to
produce a lenticule with precise dimensions to
correct the patient’s refractive error, including
myopia, hyperopia, and astigmatism. These
two cuts are one of the main reasons why Dr.
Wilson has reservations about the technique,
although he is not opposed to it.
“It’s important to point out its potential advantages and potential limitations relative to
the other procedures that we’re already using,
LASIK and PRK,” said Dr. Wilson, professor of
ophthalmology, director of corneal research,
and cornea and refractive surgery fellowship
director, Cole Eye Institute, Cleveland Clinic.
The precision of the cuts made with the femtosecond laser versus those made with an excimer laser is what concerns him most.
“We have been using the femtosecond laser
for many years to make flaps for LASIK, and we
know that no two cuts are the same,” Dr. Wilson said. “They all have different OBL (opaque
bubble layer) patterns.”
FORGIVENESS WITH LASIK
In LASIK when only one cut is made with that
laser, there is a lot of forgiveness for those imperfections because afterward, the flap is lifted
and the ablation is done on the bed. When the
flap is replaced back down, those imperfections
still line up as long as you align the flap back
in its original position because there is only
one interface, Dr. Wilson explained.
“But when you make two cuts with the femtosecond laser and those two cuts are never
the same, then when the two surfaces become
opposed to each other, there’s going to be some
irregularity,” Dr. Wilson continued. “Some of
that is going to be transmitted to the anterior
surface of the cornea. That translates into a
certain level of irregular astigmatism inherent in that procedure.”
Irregular astigmatism after SMILE—Why?
SMILE
Femto LASIK
This illustration shows the interface difference between SMILE and LASIK. (Image courtesy of Steven E. Wilson, MD)
This lack of precision could proDr. Wilson suggested that the
duce results that are less accurate
precision of the SMILE procedure
than those achieved with LASIK
could be substantially improved by
and PRK, Dr. Wilson said.
using either more pulses or pulses
Small incision
He referred to an evaluation of lenticule extraction
distributed closer together when
the safety and complications of (SMILE), which has not
making the two lamellar cuts. This
SMILE (Iversen et al. Ophthalmol- yet been approved for
would reduce or eliminate the step
ogy. 2014;121:822-828) as one of the refractive correction in
of inserting a spatula to break the
best studies to date on this topic.
adhesions between the lenticule and
the United States, may
In this study of 922 patients treated be less accurate and
the anterior and posterior stroma.
with SMILE at a center in Denmark, produce more irregular
“There will always be some limithe mean preoperative spherical astigmatism than LASIK tations because no two femtosecond
equivalent refraction was –7.25 D or PRK because of the
cuts are the same, but I think you can
± 1.84 D. The average postopera- imprecision resulting
make them more precise,” he added.
tive refraction was –0.28 D ± 0.52 from the two incisions
D, meaning that about 5% of eyes needed to create the
SECOND ISSUE
were expected to be more than 1 D lenticule. However, the
A second issue Dr. Wilson raised
from average, and the mean error treatment is promising
was that some patients treated with
of treatment was –0.15 D ± 0.50 D. and may stand the
SMILE would need enhancements,
By 3 months, 86% (1,346 eyes) test of time as the
as is true with any refractive surhad unchanged or improved best- technology advances.
gery procedure because of variabilcorrected distance visual acuity. A
ity in the wound-healing response
loss of 2 or more lines was observed in 1.5% between individual patients.
of eyes; however, at a late follow-up visit, cor“Assuming that’s going to be somewhere
rected distance visual acuity was within 1 line between 5% and 15% of patients, how will
of the preoperative level in all eyes.
those enhancements be performed?” he asked.
The authors of this study concluded that “There’s a risk in trying to recut the lenticule
SMILE had an acceptable safety profile and and do another SMILE-type procedure because
that patient satisfaction was high.
those two procedures could intersect each other.
take-home
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
You’ll end up with fragments of
stroma not attached anywhere.”
PRK with mitomycin C seems to
be the safest method if re-treatment
is needed, Dr. Wilson said. While
enhancement with PRK is an acceptable solution, it seems to defeat
the concept of SMILE to resort to
the surface technique to achieve
the desired results, he added.
However, a modification that
would enable surgeons to make
side cuts into the interface, converting the SMILE procedure into
LASIK, is being evaluated.
P O T E N T I A L A D VA N T A G E
Citing a potential advantage of the
SMILE technique, Dr. Wilson noted
that it might cause less LASIK-induced dry eye if more of the anterior nerve trunks are spared. It
may also have biomechanical advantages, such as maintaining the
strength of the anterior stroma,
which provides a significant proportion of corneal rigidity.
However, surgeons should be cautious when treating patients with
DECISIONS
tive and cataract indications. The
Femto LDV models have the lowest pulse energy and spacing with
the highest pulse frequency and
their own unique modified raster
pattern along 1-mm tracks. The
Z4 model does not offer a side cut.
The VisuMax causes the least
corneal compression and is most
technically sophisticated. It is also
currently the only system that can
be used for small-incision lenticular extraction (SMILE), a femtosecond-only refractive surgical
procedure with a small incision.
Since SMILE is gaining popularity internationally, surgeons in the
United States who have access to
this laser will have an advantage
when SMILE gains FDA approval,
Dr. Krueger said.
traditional risk factors for keratoconus or low biomechanical rigidity.
CAR EFUL ATTENTION
“If a patient has irregular corneal
topography or decreased corneal
thickness or both, you have to be
very careful in applying SMILE,”
Dr. Wilson said, adding that several cases of ectasia associated with
this technique have been reported.
Although the SMILE procedure
is performed in more than 30 countries, it is still undergoing clinical
trials in the United States prior to
regulatory approval.
“We’re at the beginning,” Dr.
Wilson said. “Like many procedures, it may improve over time.
We still don’t know with SMILE.” ■
STEVEN E. WILSON, MD
This article was adapted from Dr. Wilson’s presentation during
the 2015 meeting of the American Academy of Ophthalmology.
Dr. Wilson does not have any commercial interests related to
the topic; however, he has been a trainer for VISX.
Of the five femtosecond lasers
that can be used for cataract surgery,
the LenSx is the first in class and
current market leader. The Catalys
and LensAR platforms offer fluid
coupling, and the LensAR also
stands out for its unique sophisticated 3-D imaging system, “augmented reality,” Dr. Krueger noted.
The Victus is a curved coupling
refractive laser that was modified
to include the lens. The newest addition, the Femto LDV Z8, has very
low energy with a high repetition
rate and has both flat coupling for
the cornea and fluid coupling for
the lens. Despite these perceived
benefits, there is little information
available about its clinical performance, he noted. ■
Invaluable
PARTNER
“The Marco OPD System provides
me with spherical aberration data,
to better determine and integrate
the most appropriate Wavefront
enhanced PCIOLs for my patients.
It also displays corneal and lenticular
astigmatism which assists me when
implanting toric IOLs. This product is
an invaluable partner in my practice.”
Farrell ‘Toby’ Tyson, MD, FACS
Cape Coral, Florida
RONALD R. KRUEGER, MD, MSE
This article was adapted from Dr. Krueger’s presentation during
World Cornea Congress VII preceding the 2015 meeting of
the American Society of Cataract and Refractive Surgery. Dr.
Krueger is a consultant to Alcon Laboratories and LensAR.
Designed and Manufactured by NIDEK - Represented by Marco
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20
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
Inlay yields effective, sustained
correction of presbyopia over time
Recent FDA approval a direct result of outstanding efficacy, safety demonstrated
By Lynda Charters; Reviewed by John A. Vukich, MD
MADISON, WI ::
IMPLANTATION OF A small-aperture
Visual Acuity (logMAE)
Extended Depth-of-Focus
–0.2
–0.1
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
5.0
Visual Gain
20/40
4.0
3.0
2.0
1.0
Preop
0.0
Defocus (D)
12 mon
–1.0
–2.0
–3.0
0.75 D shift
–4.0
–5.0
N=114
(FIGURE 1) The corneal inlay provides reliable, extended depth-of-focus for patients with presbyopia. When
paired with a small amount of myopia, patients can achieve up to 2.75 D of functional depth-of-focus.
(Data from the KAMRA inlay U.S. IDE pivotal trial)
Long-Lasting Results
UCDVA IE
Visual Acuity (ETDRS Letters)
inlay improves near visual acuities while retaining good distance vision over 3 years in
emmetropic presbyopes.
The corneal inlay (Kamra, AcuFocus Inc.)
was designed specifically for
patients with presbyopia aged
45 to 60 years, according to
John A. Vukich, MD, private
practice in Madison, WI.
The device fills a need for
patients between LASIK perDr. Vukich
formed to treat refractive errors in patients aged 20 to 40 years and multifocal IOLs following cataract extraction in
older patients.
“The corneal inlay provides reliable extended
depth-of-focus for presbyopic patients whose
lenses cannot change focus for near visual
tasks,” said Dr. Vukich, who is also associate clinical professor, University of WisconsinMadison Medical School, Madison. “The smallaperture design only allows focused central
light rays to reach the retina, resulting in continuous functional vision without blur zones.”
Results from the KAMRA inlay U.S. IDE pivotal trial of 114 patients indicated that when
paired with a small amount of myopia, patients can achieve up to 2.75 D of functional
depth-of-focus.
The inlay is not monovision, he noted, because it allows patients to maintain stereopsis
and binocular vision.
Patients in the U.S. IDE trial were able to
achieve significant functional depth-of-focus
with essentially no change in their distance
vision, he said.
“The mean stereoacuity scores were maintained between preoperatively and 6 months
after the inlay was implanted,” he said.
Steve Linn, MD, and Phillip Hoopes, MD,
reported at the 2012 meeting of the Association for Research in Vision and Ophthalmology
that, in 60 patients, the mean distance preoperative stereoacuity was 36.1 arc seconds. Six
months postoperatively, the value was 35.5 arc
seconds in patients who underwent implantation of the inlay.
UCIVA IE
UCNVA IE
55
20/20
50
45
40
20/32
35
20/40
30
20/63
25
20
N=
0
6
12
508
499
478
18
Month
445
24
30
36
436
398
417
(FIGURE 2) An average 2.9-line gain at 12 months was achieved and sustained over the duration of the
study. Achieved results remain stable over the 36-month follow-up.
(Figures courtesy of John A. Vukich, MD)
EMMETROPIC PR ESBYOPES
Dr. Vukich evaluated the performance of the
corneal inlay in a prospective, non-randomized
clinical trial of 154 naturally occurring emme-
tropic presbyopes. To be included in the study,
the patients had been implanted monocularly
with the device in the non-dominant eye to
correct their presbyopia, they had an uncor-
21
Special Report )
Inlay receives
approval after
decade of research
IRVINE, CA ::
ACUFOCUS’ CORNEAL INLAY (Kamra) was approved by the FDA in April. The device is indicated to
improve near vision by extending depth of focus in patients with presbyopia who have emmetropic refractions (+0.50 to –0.75 D).
“After a decade of research, development, and clinical investigation, we are delighted to bring this innovative technology to surgeons and patients in the United
States,” said Jim Mazzo, chairman and chief executive
officer of AcuFocus.
The approval was based on the results of 508 patients treated at 24 investigational sites worldwide.
Patients in the clinical study experienced an average
improvement in uncorrected near visual acuity of 3 lines
between their preoperative exam and the 12-month
follow-up visit. This improvement was maintained over
the 5-year duration of the study.
Mean preoperative uncorrected distance visual acuity in the inlay-implanted eye was maintained across
all follow-up exams, unlike other presbyopia-correcting
procedures where distance vision is compromised in
order to improve near vision, according to the company.
“Surgical options for patients frustrated with near
vision loss have previously been limited and often required patients to accept compromises like loss of
effect over time,” said John A. Vukich, MD, associate
clinical professor, University of Wisconsin-Madison
Medical School, Madison. “With the inlay now available in the United States, we have a safe, effective,
and long-term solution for presbyopes that is designed
especially for their needs.” ■
rected near visual acuity (UCNVA) of worse
than 20/40 and better than 20/100, and a bestcorrected distance visual acuity (BCDVA) of
20/20 or better in both eyes, with a spherical
equivalent between +0.50 to –0.75 D.
Three years after implantation in this population, the device continued to be efficacious
over time, he noted.
“The patients achieved an average gain in
near vision of 2.9 lines at 12 months that was
sustained and stable over the 36-month followup period,” Dr. Vukich said.
The mean UCDVA was virtually unchanged
from 20/18.5 to 20/20. The vast majority (92%)
of patients had 20/25 or better 3 years postoperatively. Almost all (96%) were within ± 1 D
of the targeted correction, he noted.
No patient lost 2 or more lines of BCDVA at
the 3-year evaluation.
ADVANCEMENTS IN
REFRACTIVE SURGERY
“The results of this clinical trial are compelling,” Dr. Vukich said. “The recent FDA
approval of [the device] for use in the United
States is a direct result of the outstanding efficacy and safety that were demonstrated.” ■
JOHN A. VUKICH, MD
This article was adapted from Dr. Vukich’s presentation at the 2015 meeting of the
American Society of Cataract and Refractive Surgery. Dr. Vukich is a paid consultant
to AcuFocus.
Femtosecond
INSTRUMENTS
Thorlakson Eye Speculum
K1-5673
Adjustable mechanism 10mm
rounded wire blades designed
to accommodate the suction
ring of the FEMTO LDV TM laser.
FEMTO LDV TM is a trademark of
Ziemer Ophthalmic Systems AG
Thorlakson
Z-LASIKTM
Flap Lifter
K3-2536
K3-2537 short handle
Combines a 1mm long,
extra fine modified Sinskey
Hook and a 12mm long
bi-convex spatula with
beveled notches. To lift
LASIK flaps created with a
femtosecond laser.
Z-LASIKTM is a trademark of
Ziemer Ophthalmic Systems AG
IntraLase®
Flap Lifter
K3-2538
Combines a 1mm long Sinskey
Hook for finding the flap edge and
a long, blunt, 11mm long hook to
undermine the flap perpendicular
to the hinge.
IntraLase® is a registered trademark of AMO
973-989-1600 r 800-225-1195 r www.katena.com
®
22
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
Femtosecond laser flap creation works
for patients with previous RK surgery
More studies necessary as technique appears to be safe and effective in these patients
By Nancy Groves; Reviewed by Sloan W. Rush, MD
AMARIL LO, T X ::
FEMTOSECOND-ASSISTED LASIK
DEFAULT MANUFACTURER
NOVEL POST-RK
in eyes that had previously undergone radial
FEMTOSECOND
FEMTOSECOND
FEMTOSECOND LASER
keratotomy (RK) was successful in all cases
LASER FLAP SETTINGS
LASER FLAP SETTINGS
PARAMETER
at a single-center study.
Although further studies are necessary, the
Bed Cut Energy (μJ)
0.8
1.4
technique for femtosecond laser flap creation
appears to be safe and effective in these patients,
Bed Cut Spot Separation (μm)
8.0
6.0
said Sloan W. Rush, MD, private practice in
Amarillo, TX, who performed the procedures.
Bed Cut Line Separation (μm)
8.0
6.0
None of the 27 eyes (18 patients) had significant intraoperative or postoperative compliSide Cut Energy (μJ)
0.8
0.8
cations. Uncorrected visual acuity improved
significantly postoperatively (p <0.0001) and
Side Cut Spot Separation (μm)
5.0
5.0
remained stable through the final follow-up, 9
to 12 months later, Dr. Rush noted.
Side Cut Line Separation (μm)
3.0
3.0
Many patients who underwent RK in the
late 1980s and 1990s later developed hyperopic
(TABLE 1) Novel femtosecond LASIK flap settings compared with the default manufacturer settings on the
regression and have sought additional refracFS200 femtosecond laser. (Table courtesy of Sloan W. Rush, MD)
tive treatment. While LASIK performed with
mechanical microkeratome techniques and an
excimer laser was often successful in post-RK flap. He and colleagues at the Amarillo clinic
patients, the development and growing use of adjusted spot sizes and increased the power
femtosecond laser technology presented a new so that the femtosecond laser would leave a
minimal number of tissue bridges,
set of problems, Dr. Rush said.
in turn allowing the surgeon to
This laser creates stromal tissue
more easily lift the flap.
bridges that have to be cut with
He retrospectively reviewed the
a spatula or other instrument, incharts of all post-RK patients who
creasing the risk of reopening an
The first case series
underwent femtosecond-assisted
old RK incision and traumatizing
report of femtosecond
LASIK on the Wavelight FS200 femthe flap.
tosecond laser and the Allegretto
Other problems that have been laser flap creation
Wave Eye-Q 400 Hz excimer laser
reported when using the standard for LASIK in eyes that
(both Alcon Laboratories) from Sepfemtosecond laser setting have in- have undergone radial
tember 2013 through February 2014.
cluded loss of suction during treat- keratotomy showed
— Sloan Rush, MD
The laser settings for flap creation
ment, postoperative interface in- the technique was
were: bed cut energy, 1.4 μJ; bed
flammation, corneal haze, and successful when novel
cut spot separation, 6.0 μm; bed RK,” Dr. Rush said. “In my center, now that
loss of best spectacle-corrected settings were used.
cut line separation, 6.0 μm; side we have figured out settings that work well,
visual acuity (BSCVA). Performing additional surgery has also been difficult cut energy, 0.8 μJ; side cut spot separation, we permanently put our microkeratome on
the shelf.” ■
in patients who had undergone both RK and 5.0 μm; and side cut line separation, 3.0 μm.
All of the flaps were lifted with no complicataract surgery.
cations, there were no cases in which suction
was lost, and no RK incisions were reopened.
SETTING EXPERIMENT
SLOAN W. RUSH, MD
Since there was no indication on the femtosec- In addition, no subjects lost any lines of BSCVA.
“I believe this is the first report in which
ond laser to guide refractive surgeons treating
This article was adapted from Dr. Rush’s presentation during the 2015 meeting of
post-RK patients, Dr. Rush experimented with someone has described successfully using the
the American Society of Cataract and Refractive Surgery. Dr. Rush did not report any
the settings, seeking a way to make a cleaner femtosecond laser in the setting of previous
relevant financial relationships.
take-home
‘This is the first
report . . . someone
has described successfully using the
femtosecond laser
in the setting of previous RK.’
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Page 2
24
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
Riboflavin delivery methods advance
as crosslinking techniques evolve
Oxygen will play role in future of CXL; widespread applications showing potential
By Nancy Groves; Reviewed by George O. Waring IV, MD, FACS
CHARL ES TON, SC ::
THE CLASSIC PARADIGM FOR
on we’re not so much blocking the riboflavin
corneal collagen crosslinking (CXL) is evolv- but limiting the oxygen diffusion, Dr. Waring as researchers learn more about the role ing noted.
of oxygen and investigate alternative methods
“So the thinking has changed a little bit,”
for delivering riboflavin.
he said. “It may be as or more important that
The expansion of CXL be- the epithelium is a barrier to oxygen, and that
yond treatment of keratoco- may be why we’re seeing a better effect with
nus and into primary refrac- the epithelium off.”
tive correction is also on the
Nonetheless, both the epithelium-on and ephorizon, according to George ithelium-off techniques have advantages and
O. Waring IV, MD, FACS.
disadvantages, Dr. Waring said.
The standard approach to
“Epi-off may work better, as data suggests,”
Dr. Waring
CXL has been to deliver ribo- he said, “but we feel that epi-on can also work,
flavin to the corneal stroma and activate it although perhaps not as well, but we can avoid
with ultraviolet light, which biomechanically the rare-but-potential side effects associated
strengthens weak ectatic corneal tissue. Classi- with epithelium removal, such as prolonged
cally riboflavin was delivered into the stroma surgical time, risk of infection, sterile infilby removing the corneal epithelium, which trates, prolonged healing time, and discomfort
acts as a natural barrier, and allowing it to during healing. We’re trying to figure out how
be absorbed by passive imbibition. In passive we can get the benefits of both.”
imbibition, the riboflavin is allowed to diffuse
naturally, with the epithelium off or with use
A LT ER I NG CL AS SIC
of bioenhancers to loosen the epithelial tight
C X L PA R A DIGM
junctions.
The quest for improved CXL techniques has
The relative merits of the epi-on and epi-off included development of active imbibition
techniques have been debated for
methods, such as iontophoresis,
years, said Dr. Waring, assistant
to accelerate riboflavin delivery,
professor of ophthalmology and diDr. Waring said.
rector of refractive surgery at Med“Riboflavin can be turned into
ical University of South Carolina
a
prodrug
form and have a charge
Techniques for
Magill Vision Center, Charleston. performing corneal
delivered to it, then you can drive
Although both are effective, collagen crosslinking
it through the epithelium actively,”
“there is a reasonable amount of are being evaluated
he said. “You’re leaving the epidata to support that epithelium- and adapted, and
thelium in place, but you’re still
off may work better,” Dr. Waring at the same time
getting the drug through.”
said. “The conventional thinking new applications
Preclinical studies performed
was always that it works better are being developed.
by Sooft Italia several years ago
because we’re getting more ribodemonstrated that the company’s
flavin into the stroma.”
device and method for corneal delivery of riHowever, recent work in Dr. Waring’s lab boflavin by iontophoresis were effective, and
and elsewhere suggests that the picture is more early clinical use has begun.
complex and that oxygen also plays a signifiOther developments also are likely to alter
cant role in CXL.
the classic CXL paradigm.
Dr. Waring explained that the oxygen is used
“More and more we’re realizing the potenfairly quickly in the crosslinking process, and tial of corneal crosslinking,” Dr. Waring said.
once the levels are sufficiently depleted, the “We may be able to use it for more advanced
crosslinking effect is also reduced.
topographic-guided treatments, which may give
“It’s possible that by leaving the epithelium us better effectiveness.”
take-home
As one example, William (B.J.) Dupps, MD,
Cleveland Clinic, has tested crosslinking just
the cone of a select area of the ectatic cornea,
treating only the weakened area to achieve
compensatory regularization of the corneal
curvature.
Selective topographic-guided crosslinking
potentially opens the way for refractive treatments in normal eyes for low amounts of myopia, hyperopia, or astigmatism. This work is
being done by Avedro, which has introduced
a photorefractive intrastromal crosslinking
procedure (PiXL) and technology (not for sale
in the United States).
“A number of patients have been treated
outside the United States with promising results,” Dr. Waring said.
“If we put all this together, there might be
a role for combined LASIK and crosslinking
for some of our borderline candidates, for
limited crosslinking, or for hyperopic treatments that have a higher chance of regression,” he continued.
Dr. Waring was co-author with Tomita et
al. of a study of simultaneous LASIK and CXL
in patients with bilateral myopia. (J Cataract
Refract Surg. 2014;40:981-990.)
“We found safety and stability in the refractive outcomes in a large group of patients,”
he said.
“We’re still learning about the mechanisms
of corneal crosslinking—they’re much more
complex than we originally thought—and how
to optimize treatment,” Dr. Waring said. “The
focus is really going to be on the role of oxygen in the future, but there’s widespread
potential application for this technology.” ■
GEORGE O. WARING IV, MD, FACS
P: 843/792-1414
This article was adapted from Dr. Waring’s presentation during the 2015 meeting
of the American Society of Cataract and Refractive Surgery. Dr. Waring serves as an
investigator and member of the scientific advisory board for Avedro Inc.
25
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
Corneal inlay for presbyopia improves
near vision without added dysphotopsia
Initial study results show good near visual performance, high levels of patient satisfaction
By Lynda Charters; Reviewed by Ralph Chu, MD
BLOOMINGTON, MN ::
INITIAL RESULTS WITH an investigational device for correcting presbyopia (Raindrop Near Vision Inlay, ReVision Optics) are
promising.
The device improves near visual performance
without added visual disturbance in pseudophakic patients, said Ralph Chu, MD, private
practice in Bloomington, MN.
Other options used to correct presbyopia include monovision LASIK, which provides good
intermediate vision but patients may have to
depend on spectacles for near-vision tasks. Implantation of multifocal IOLs is another option,
but vision can be affected by glare and halos
in more than 75% of patients.
“The near vision inlay improves near vision
without dysphotopsia,” Dr. Chu said.
The device is a microscopic hydrogel inlay, 2
mm in diameter and about 32-μm thick. When
the inlay is implanted under a flap, creased
with a femtosecond laser, it changes the curvature of the cornea to a prolate shape, according to Dr. Chu.
U. S . I DE ST U DY
Dr. Chu evaluated his group of 25 subjects
with the device implanted as part of a U.S. IDE
study. In a multicenter study, he assessed and
opes (13 patients), the latter of which had a kic group and 83% of the pseudophakic group
monofocal IOL.
achieved 20/20 or better at distance and near.
In both groups, the implant was put into
“There were minimal reports of visual sympthe nondominant eye. Dr. Chu measured the toms for both groups at 3 months with a slight
near, intermediate, and distance visual acu- increase in ocular dryness in the pseudophakes,”
ities. He followed with a patient survey to mea- Dr. Chu said.
sure how well patients were able to perform
tasks and their levels of satisfaction with the
SOME OCULAR DRYNESS
implanted device.
Eight percent of the patients with pseudophakia
The phakic patients were an average of 49 reported ocular dryness. In the phakic group,
years of age (range, 46 to 56 years).
visual glare and halos were reThe preoperative manifest refracported by 4% each.
tion spherical equivalent (MRSE)
In the phakic group, 84% rewas 0.30 D (range, –0.25 to 1.00
ported little or no difficulty perD), the preoperative add was 1.71
forming near hobbies; 100% of
The near vision
D (range, 1.50 to 2.25 D). The pa- inlay improves nearthose in the pseudophakic group
tients were followed for 12 months. visual performance
reported little or no difficulty with
The pseudophakic patients were without added visual
near hobbies.
an average age of 65 years (47 to disturbance in
The level of patient satisfaction
78 years). The preoperative MRSE pseudophakic patients.
was high in both groups, i.e., 97%
was –0.02 D (range, –0.50 to 0.38
in the phakic group and 100% in
D), and the preoperative add was
the pseudophakic group, accord2.06 D (1.75 to 2.50 D). The patients were fol- ing to Dr. Chu.
lowed for 3 months.
The inlay improves near vision equally in
In the phakic group, 84% of patients had phakic presbyopes and in pseudophakes, he
20/20 or better uncorrected near visual acu- summarized. The percentages of moderate
ity 3 months postoperatively. By 12 months or worse visual symptoms were low in both
postoperatively, all patients reached that vi- groups, with 4% of phakic subjects reporting glare and halos. No pseudophakic subjects reported either glare or halos postoperatively. The rates of patient satisfaction
were high in both groups. The initial results
showed that the inlay improves near visual
performance without added dysphotopsia in
pseudophakic patients. ■
take-home
The level of patient satisfaction was high
in both groups, i.e., 97% in the phakic group
and 100% in the pseudophakic group.
compared the initial feasibility of implanting
the device in patients who had previously undergone cataract surgery and IOL implantation
as part of the Raindrop Near Vision Inlay U.S.
study. All patients were either phakic presbyopes (25 patients) or pseudophakic presby-
sual acuity level, Dr. Chu noted.
In the pseudophakic group, the results were
similar. At 3 months, 83% of patients had 20/20
or better uncorrected near visual acuity.
Measurement of the uncorrected binocular
vision at 3 months showed that 95% of the pha-
RALPH CHU, MD
This article was adapted from Dr. Chu’s presentation during the 2015 meeting of the
American Society of Cataract and Refractive Surgery. Dr. Chu is a clinical investigator
for ReVision Optics.
26
Special Report )
ADVANCEMENTS IN
REFRACTIVE SURGERY
Cutting-edge LASIK technologies still
emerging in quest for perfect vision
Refinements in ablation profile, data used to create it are turning points to 20/20
By Lynda Charters; Reviewed by Steven C. Schallhorn, MD
SAN DIEGO ::
OVER THE YEARS, LASIK has moved
forward by leaps and bounds—with each new
added technology further maximizing vision
via innovative means. The majority of patients
can now achieve uncorrected visual acuities of
20/20 or better and, compared with the early
days, there is now far better quality of vision.
But surgeons did not reach this level of excellence overnight. Some key steps between the introductions of LASIK performed using a conventional procedure and wavefront-guided ablations
were the improvements in the laser algorithms,
development of sophisticated
eye trackers and cyclotorsional
alignment, and use of the femtosecond laser to create flaps.
However, the greatest improvements in the quest for
perfect vision have been refineDr. Schallhorn
ments in the ablation profile
and the data used to create it, said Steven C.
Schallhorn, MD, in private practice in San Diego.
CONVENTIONAL ABLATIONS
The first foray into refractive correction was
the conventional or standard ablation, which
was based on the spectacle prescription and
utilized the Munnerlyn formula for the ablation profile.
The Munnerlyn formula correctly and precisely calculates the treatment profile to treat
the refractive error, but it does not account
for the healing response and the variability in
the amount of tissue removed by each laser
pulse. The conventional correction is a simple
and straightforward procedure that removes
a minimal amount of tissue. The surgery effectively reduces patients’ need for spectacle
or contact lens correction.
However, spherical aberration and other
higher-order aberrations (HOAs) can be induced which are associated with night vision
difficulties. In addition, complex treatments
cannot be performed.
OPTIMIZED LASIK
This surgery addressed the induction of spherical aberration with conventional procedures.
Dr. Schallhorn explained that in an optimized vision compared with a conventional treatment.
treatment, “extra laser pulses are added in the
The eye is imaged with the aberrometer (such
periphery of a myopic treatment to account as the iDesign, Abbott Medical Optics), the
for average induction of spherical
treatment is calculated, the plan
aberration.”
is transferred to the excimer laser,
Like the conventional procedure,
and the treatment is aligned with
this also is simple and straightforthe wavefront capture.
ward, but it significantly decreases
Positives are that whole-eye abThe various excimer
the induction of spherical aberra- ablation technologies
errations are measured and taken
tion. It also is similar in that the have their pros and
into account in the ablation protreatment is based on the specta- cons. Wavefrontfile—even in highly aberrated eyes;
cle refraction.
alignment is sophisticated; and adguided ablations
Disadvantages of the optimized using aberrometry
justment can be made for the angle
approach, according to Dr. Schall- can provide the vast
kappa. The approach has a range of
horn, are that the spherical aberra- majority of patients
FDA approvals, and outcomes are
tion adjustments are a population- with uncorrected vision
well established in the literature.
based pattern, it cannot address of 20/20 with fewer
Dr. Schallhorn describes this
other optical aberrations which postoperative visual
surgery as very accurate with betmay be present, and that complex symptoms. ter results than conventional protreatments cannot be performed.
cedures, such as fewer HOAs and
In topography-guided ablations, the patient’s improved contrast sensitivity, translating into
entire corneal shape is taken into account when better quality of vision.
deriving the ablation profile. Topography inOn the downside, additional time and exformation is transferred to the excimer laser penses are required, such as:
> Purchasing the aberrometer device;
to maximize the treatment.
> High-quality wavefront measurement and inAdvantages are that the “cosine effect” on
each laser pulse can be precisely determined,
terpretation is necessary;
> Accurate wavefront capture is not always
resulting in an improved ablation algorithm,
and that substantial cornea-induced optical
possible;
> Ablation profile removes more tissue than a
aberrations, specifically from previous surgery
or trauma, can be addressed.
conventional procedure;
> Ablation profile still can induce HOAs.
Disadvantages include added surgical time
and expenses of interpreting and transferring
topography information to the excimer laser, the
“It is clear that each ablation profile has its
correction is based on the manifest refraction advantages and disadvantages,” Dr. Schallhorn
and refined nomograms are needed to prop- said. “Spherical aberration is the most signifierly correct the refractive error. In the United cant HOA induced by laser-vision correction
States, the procedure is approved to treat only and this is being addressed with modern ablow-to-moderate myopia with astigmatism.
lation profiles. Enhanced customization to the
individual patient has improved the treatments
WAV E F R O N T- G U I D E D
we can now perform.” ■
This approach differs markedly from conventional and optimized procedures in that it
uses an aberrometer to customize the treatSTEVEN C. SCHALLHORN, MD
ment by taking into consideration all optical
aberrations present in the eye, including the
This article was adapted from Dr. Schallhorn’s presentation during the 2015 meeting of
refraction. This results in improved contrast
the American Society of Cataract and Refractive Surgery. Dr. Schallhorn is a consultant
sensitivity, decreased glare, and better night
to Abbott Medical Optics (AMO) and Carl Zeiss Meditec.
take-home
clinical diagnosis
Referral criteria trumps
amblyopia screening tools
Latest technology offers customization to address patient age, sensitivity, specificity
By Lynda Charters; Reviewed by Sean P. Donahue, MD, PhD
NASHVIL L E ::
ew screening technologies have away from the visual axis. By evaluating how
revolutionized the early detec- the flash returned from the retina, clinicians
tion of amblyopia, by allow- were able to interpret the possible refractive
ing children to be screened error and strabismus
long before they are able to because the flash was
cooperate with reading an out of focus in a noneye chart.
emmetropic eye, Dr.
These instruments—photoscreeners and au- Donahue explained.
torefractors—work by detecting risk factors
Having used this
for amblyopia (anisometropia, high bilateral i n st r u ment for 20
hyperopia and astigmatism, and strabismus) years on millions of
rather than amblyopia itself.
patients in TennesAnother advantage is that see and worldwide,
—
the instrument software can he pointed out that
be customized based on the most children can be
age of the patient, or the de- screened successfully.
sired sensitivity or specificity,
“Depending on the referral criteria, very high
by altering the referral criteria predictive values can be obtained,” he said.
Dr. Donahue
“The Iowa Group has predictive values over
the package uses.
The most important factor, according to Sean 85% in detecting AAPOS [American AssociaP. Donahue, MD, PhD, is not what instrument tion for Pediatric Ophthalmology and Strabisshould be purchased but the referral criteria mus] vision screening criteria for amblyopia
risk factors.”
put into the instrument in order
Disadvantages of the technolto appropriately refer children.
ogy are its age, analogue verDr. Donahue is professor of ophPhysicians should
sus digital images, and delayed
thalmology, neurology, and pefocus on referral
interpretation because of the
diatrics, Vanderbilt University
criteria in screening
absence of automated reading.
Medical Center, and chief, Peditechnology rather
The next off-axis photoatric Ophthalmology, Vanderbilt
than the instrument
screener to become available
Children’s Hospital, Nashville.
itself.
was the iScreen (iScreen ViFour types of refractive screension) with advances, such as
ing instruments are available:
a digital camera in a single> Off-axis photoscreeners,
flash unit. The image is transmitted by com> Automated refractors,
puter to a reading center, and the results are
> Retinal birefringence, and
returned the following day. The data from this
> Visual-evoked potentials.
instrument is good, according to Dr. Donahue.
N
printout and two sets of referral criteria, one
from the manufacturer and the other criteria
proposed by the Vision in Preschoolers (VIP)
‘Age has less of an impact on
results than previously thought,
based on the Amblyopia Treatment
Studies.’ Sean P. Donahue, MD, PhD
TAKE-HOME
Of these, the first two devices are the most
commercially available.
OF F-A X IS PHOT OSCR EEN ING
MTI (Medical Technologies and Innovations),
the oldest and the primary example of these instruments, was based on an analogue picture.
The fundamental concept was a linear flash
AU TOR EFR ACTOR S
These instruments were the next step in screening technology. Advantages include a target for
the child to look at and ultrasound measurement of the refractive error. The Nikon Retinomax and the Welch Allyn SureSight became
available in the late 1990s, and the latter received the most attention with its hard-copy
Program, which has a higher specificity and
slightly less sensitivity, Dr. Donahue noted.
Despite these advantages, the SureSight instrument had a high referral rate of 7.3%, but
a predictive value positive of only 48% in his
studies. Adjusting the referral criteria to decrease the referral rate jeopardized the sensitivity, Dr. Donahue noted.
M A N UFACT UR ER OR CR ITER I A
When ordering this instrument, physicians
must choose between the manufacturer or
the VIP criteria.
“With the manufacturer’s criteria, about 15%
of patients will be referred with a predictive
value positive of 10%, meaning that only one
of 10 children referred is going to have a visual problem,” he said. “The VIP criteria have
94% specificity and a predictive value of about
45%, which is better for the vast majority of
preschool vision screening applications.”
PlusOptix Mobile Vision Screener (PlusOptix GmbH), the next autorefractor, has the advantage of being able to alter the referral criteria. The S12 is the most currently available
iteration of the technology. The characteristic
that Dr. Donahue likes about this device is
the availability of five sets of referral criteria,
which the user can choose.
Continues on page 28 : Amblyopia
27
28
clinical diagnosis
AMBLYOPIA
The instrument also has high sensitivity
(85%) and specificity (90%), and a lower referral rate with a high predictive value and a
higher referral rate with a lower predictive value.
“All of these have published data to support them,” Dr. Donahue said. “The choice is
based on preference. Do you want to refer a lot
of children and not miss anything, or do are
you in situation where the children are in a remote location and must come to a center and a
Check Kids. There currently are no published
data on this instrument.
However, as Dr. Donahue pointed out, “If
this is proven to work, it is not an $8,000 capital investment as the other instruments are.”
Several other instruments are under development but are not yet commercially available.
SCR EENING CONSIDER ATIONS
Patient age has always been a factor in screening.
“However, age has less of an impact on results than previously thought, based on the Amblyopia Treatment Studies,” Dr. Donahue said.
For anisometropic amblyopia, the prevalence
of amblyopia seems to be fairly constant based
on the magnitude of the difference between
the eyes. However,
with time, the depth
of the amblyopia increases, he noted.
Dr. Donahue advised identifying the
amblyopia early and
at the latest, by 5
years of age. However, because some
amblyopia resolves
with spectacle treatment alone, it may be important to treat the
1- and 2-year-old patients, which underscores
the importance of early screening.
He identified three elements that ophthalmologists should know:
‘The choice does not depend
on the instrument, but on the
referral criteria.’
— Sean P. Donahue, MD, PhD
high number of false positives is not desired?”
A third autorefractor (PediaVision Spot,
Welch Allyn) is a handheld wireless device
with adjustable referral criteria that has higher
sensitivity than the PlusOptix instrument but
poorer specificity of 75% when the manufacturer’s criteria are used. Dr. Donahue has been
working with the manufacturer to collect data
in an attempt to improve the specificity and
decrease the referral rate.
Gobiquity has introduced a device that uses
a smartphone with an application called Go-
> The U.S. Preventive Services Task Force
(USPSTF);
> CPT code 99173 for traditional screening;
> CPT code 99174 for photoscreening and
photorefraction.
The USPSTF statement, published in 2011,
advises that photoscreening is useful in children aged 3 to 5 years.
“This is the first time that a major organization has stated this,” Dr. Donahue said.
The USPSTF also said there is insufficient
evidence to recommend photoscreening for patients less than 3 years of age. Despite that level
of recommendation, Dr. Donahue believes the
data that support the effectiveness of photoscreening in that age range “is overwhelming.”
Another important consideration for ophthalmologists is from The American Academy of
Pediatrics Instrument-Based Pediatric Vision
Screening Policy Statement, which states that
photoscreening is no longer experimental and
should be reimbursed by payers.
“Photoscreening is an alternative to traditional screening for younger children,” Dr. Donahue said. “It is not yet mandated because
of the cost.”
Considering which instrument is the best
to purchase is not the best route.
“The consideration should be: When I buy
this instrument, what criteria should be put
in to maximize what I want to detect—i.e.,
sensitivity or specificity? The choice does not
depend on the instrument, but on the referral
criteria,” Dr. Donahue summarized. ■
SEAN P. DONAHUE, MD, PHD
This article is adapted from Dr. Donahue’s presentation during Pediatric Subspecialty
Day at the 2014 meeting of the American Academy of Ophthalmology. Dr. Donahue
has been a consultant for all of the above mentioned vision screening manufacturers,
as well as for competing products; is the lead author of the AAPOS Vision Screening
Committee Recommendations regarding the detection of Amblyopia Risk Factors using
automated screening; and is the lead author of the upcoming AAPOS-AAO-AAP-AACO
combined Policy Statement about Vision Screening in Children.
Alcon pre-loaded IOL delivery technology receives CE Mark
BASEL, SWI T ZERL AND ::
ALCON LABORATORIES has earned
the European CE Mark for its AcrySof IQ Aspheric
IOL with the UltraSert pre-loaded delivery system for patients undergoing cataract surgery.
The new delivery system combines the control of a manually loaded device with the safety
and convenience of a disposable, pre-loaded
injector to optimize IOL implantation. This approval follows last month’s CE Mark for Alcon’s
trifocal presbyopia-correcting AcrySof IOL.
“Every detail of the [delivery system] has
been engineered with the needs of surgeons,
technicians, and the outcomes for their patients
in mind,” said Franck Leveiller, PhD, head of
Research and Development, Alcon Surgical.
“By simplifying the device preparation and
maximizing surgeon control in a single-use
system, we have cleared the path for more
streamlined procedures and potentially improved patient outcomes.”
The pre-loaded delivery system features the
TensionGlide Plunger, a spring-controlled mechanism designed for a smooth, controlled delivery of the IOL into the capsular bag. In addition, the system features a plunger tip which
is designed to support consistent IOL folding
and precise placement of the IOL into the capsular bag of the eye, the company said.
The design of the new delivery system also
helps to create a less-invasive corneal incision
during cataract surgery. The smaller nozzle tip
allows for a corneal incision down to 2.2 mm
for insertion of the IOL, while the Depth Guard
nozzle feature of the delivery system prevents
the device from being inserted deeper into the
incision than necessary—preserving the size
of the original corneal incision, according to
the company. ■
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30
clinical diagnosis
Autoimmune retinopathy: Diagnosis
for unexplainable vision loss
Careful history, ERG, anti-retinal antibody testing can pinpoint cause for blindness
By Vanessa Caceres; Reviewed by Byron L. Lam, MD
MIAMI ::
utoimmune retinopathy may not
be that common, but clinicians
should keep the diagnosis in
mind when a patient presents
with unexplained visual loss,
said Byron L. Lam, MD.
Autoimmune retinopathy is
broken down into three different categories:
A
Autoimmune Retinopathy
Cross-Reaction Retinal
Protein and Cancer Antigen
> Paraneoplastic retinopathy, which includes recoverin-associated retinopathy and melanomaassociated retinopathy;
> Non-paraneoplastic autoimmune retinopathy;
> Combined paraneoplastic optic neuropathy
and retinopathy.
SYMPTOMS INCLUDE
Some symptoms of autoimmune retinopathy
include subacute painless visual loss, which
is associated with scotomas, photopsias, nyctalopia, dyscrhomatopsia, and photoaversion.
Signs appear bilaterally, and the fundus can
initially appear normal. At a later stage, the
patient may show retinal atrophy, vascular at-
Retinal Inflammation
Degeneration
Cross-Reaction Retinal Protein
and Viral/Bacterial Protein
Immune Reaction
to Retinal Protein
Anti-Retinal Antibodies
Anti-Retinal Antibodies
Autoimmune Retinopathy
Retinal Atrophy
An example of the latter category is IgG against
collapsing response-mediator protein (CRMP-5).
“There are many other yet undefined causes
we don’t know about yet,” said Dr. Lam, holder
of the Robert Z. and Nancy J. Greene Chair in
Ophthalmology, Bascom Palmer Eye Institute,
University of Miami Miller School of Medicine.
Dr. Lam outlined the various triggers for autoimmune retinopathy, including cancer and autoimmune causes. With cancer, a cross-reaction
between the retinal protein and cancer antigen
may occur, leading to anti-retinal antibodies.
That leads to autoimmune retinopathy, which
often manifests as retinal atrophy, retinal pigment
epithelium changes, and optic nerve atrophy.
When there is a non-paraneoplastic autoimmune trigger, a potential mechanism may be
a cross-reaction between the retinal protein
and viral or bacterial protein, leading again to
anti-retinal antibodies and autoimmune retinopathy. Retina degeneration also may lead
to an immune reaction to retinal proteins and
secondary anti-retinal antibodies.
Autoimmune Trigger
Viral/Bacterial?
Cancer
RPE Changes
Optic Nerve Atrophy
The presence of anti-retinal antibodies does not always mean the primary problem is autoimmune
retinopathy. (Figure courtesy of Byron L. Lam, MD)
tenuation, and disc pallor. Using optical coherence tomography and autofluorescence may
help to evaluate the patient better.
If autoimmune retinopathy is suspected, Dr.
Lam advised starting with a detailed history.
For example, patients with previous small
cell lung, gynecologic, and breast cancers, as
well as melanoma, may develop the condition.
A history of autoimmune disease, hereditary
retina degeneration, or inflammatory retinopathy is important to identify other retinal conditions that mimic autoimmune retinopathy.
KEY TEST IS ERG
A key test for autoimmune retinopathy is the
full-field electroretinogram (ERG). Dr. Lam cautioned it may be more difficult to interpret the
findings in older patients, as ERG declines with
age but the range of what is normal increases
with patient’s age. Clinicians can repeat the
full-field ERG to assess progression or perform
a multifocal ERG if needed.
If ERG results show the cones are affected,
Dr. Lam said to consider anti-enolase syndrome.
“Autoimmune retinopathy is tricky because
patients without a history of cancer can develop autoimmune retinopathy,” Dr. Lam said.
“Some normal subjects may test positive for
anti-retinal antibodies. We still don’t know as
much as we like to know about the spectrum
of autoimmune retinopathies.”
If performing anti-retinal antibody testing,
Dr. Lam advised using a CLIA lab and testing for specific antibodies, such as recoverine,
enolase, CRMP-5, arrestin, aldolase, glyceraldehyde-3-phosphate, dehydrogenase, and carbonic anhydrase II. The 23-kDA protein antibody must be verified using a purified recoverin on Western blot to verify presence of
anti-recoverin antibodies, he added.
A diagnosis of autoimmune retinopathy is
supported if one of the specific antibodies above
is associated with paraneoplastic retinopathy.
“Nonspecific anti-retinal antibodies may
imply autoimmune retinopathy,” he said, “or
may be the physiologic results of retinal degeneration from other causes.” ■
BYRON L. LAM, MD
This article was adapted from Dr. Lam’s presentation during the 2014 meeting of the
American Academy of Ophthalmology. Dr. Lam did not indicate any proprietary interests
related to the topic.
31
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drug therapy
Ocriplasmin success based
on proper patient selection
Data from 5 large European centers report positive clinical experience, cost-effectiveness
By Cheryl Guttman Krader; Reviewed by Peter W. Stalmans, MD, PhD
Another concern has been that use of ocrieal-world outcomes with ocriplasmin will lead to a decline in surgical proplasmin (Jetrea, ThromboGen- cedures for vitreoretinal specialists.
“If one chooses ideal patients for ocriplasics) for the treatment of symptomatic vitreomacular adhesion min and can achieve success in
(VMA) are at least as good as, if up to 60% of those cases, there
not better, than those achieved will be 40% fewer of those ideal
in pre-marketing clinical trials. patients who will undergo surThe accumulating clinical experience is also gery,” Dr. Stalmans said.
“However, only about 1.5% of
building support for intervention with ocriplasmin in appropriately selected cases, said all vitrectomies are performed
for tractional disease of the vitPeter W. Stalmans, MD, PhD.
Providing a perspective on ocriplasmin in- reomacular interface,” he said.
jection in Europe, Dr. Stalmans noted that the “That means use of ocriplasmin
approved indication is for treatment of vitreo- will have a minimal impact on
macular traction (VMT), including when as- the number of surgeries performed.”
It has also been suggested that ocriplasmin
sociated with macular hole of diameter ≤400
μm. Based on the identification of predictors injection may be overtreatment based on the
for success in the MIVI-TRUST pivotal trial belief that the majority of VMT cases resolve
spontaneously.
program, ocriplasmin is most
Dr. Stalmans noted that a retcommonly used to treat VMT
rospective analysis he conducted
with or without a macular hole
Real-world
showed that among eyes with
≤400 μm when the adhesion
experience
with
VMT, only 25% had spontanesize is <1,500 μm and there is
ocriplasmin indicates
ous release of traction during
no epiretinal membrane.
it is an effective,
the first year of follow-up, while
A look at data from five
safe, and cost30% showed progression neceslarge centers across Europe
effective treatment
sitating vitrectomy.
shows that among eyes withfor symptomatic
“Early treatment reduces the
out a macular hole, the success
vitreomacular
likelihood of progressive visual
rate ranged from 45% to 85%.
adhesion in properly
acuity reduction, and that weighs
“The average success rate
selected eyes.
in favor of intervening with ocriamong these centers is about
plasmin,” he said.
75%, which is more than double the success rate seen in the
phase III trials,” said Dr. Stalmans, professor
C O S T- E F F E C T I V E A N A LY S I S
of ophthalmology, University of Leuven, Leu- Clinicians who argue against ocriplasmin also
point to its high price, which is about €3,000,
ven, Belgium.
Among eyes with a macular hole accompa- or about $4,000 U.S. However, results of healthnying VMT, Dr. Stalmans reported that in his economic analyses conducted in several Eurohands, the success rate has been 40%. However, pean countries show that ocriplasmin is costit has ranged from 60% to 75% at other centers. effective when it is used with proper patient
selection criteria.
“It should also be considered that unlike
R ESPONDING TO NAYSAY ERS
Dr. Stalmans noted that critics of ocriplasmin anti-vascular endothelial growth factor injecpoint to the 26.5% overall success rate achieved in tions, ocriplasmin is a one-time treatment,”
the pivotal trials. However, the data from clinical Dr. Stalmans said. “In addition, when evaluexperience indicate that with selection of appro- ating cost-effectiveness, we should not overpriate patients, the success rate is much higher. look that many patients are treated because of
L EUVEN, BELGIUM ::
R
symptoms of metamorphopsia, and resolution
of metamorphopsia translates into a gain of 2
lines of best-corrected visual acuity.”
Dr. Stalmans noted that ocriplasmin had an
‘Average success rate . . . is
about 75%, which is more than
double the success rate seen
in the phase III trials.’
TAKE-HOME
acceptable safety profile in the premarketing
trials. Although it was associated with several
adverse events, they were transient. In commercial use, no new safety signals have emerged.
Furthermore, pharmacokinetics and preclinical safety data should also ease concerns about
enzymatic degradation of ocular structures.
“We know that ocriplasmin is completely
cleared from the eye within 24 hours of injection,” Dr. Stalmans explained. “Preclinical data
show that intraretinal morphology and ultrastructure of the internal limiting membrane
are well preserved, and the rate of lens subluxation due to possible digestion of the zonular
fibers appears to be just 0.01 per 100 doses,
which I think is fairly acceptable.”
No serious systemic safety issues occurred
in trials and they are not expected—since any
ocriplasmin that enters the peripheral bloodstream would be rapidly deactivated by circulating levels of alpha2-antiplasmin, he noted.
“In other clinical settings, ocriplasmin has
been administered intravenously at a dose 1,000fold higher than the dose used intravitreally and
without any severe adverse events,” he said. ■
PETER W. STALMANS, MD, PHD
This article was adapted from Dr. Stalmans’ presentation during the 2014 meeting of
the American Academy of Ophthalmology. Dr. Stalmans receives travel fees and grant
support from ThromboGenics and is a consultant and receives travel fees from Alcon
Laboratories.
practice management
Clinic staff often creates its
own chaos through behavior
Help team members understand how cause, effect of actions can impact work of others
Putting It In View By Dianna E. Graves, COMT, BS Ed
have long preached to the staff that
“you are the chaos you create” and to
look at what is occurring around you
or to you with a critical eye.
Life’s lessons are the hardest lessons for your staff to learn. We can
teach them the latest technology, help
them refine their skills, and improve their
communication skills with patients and each
other, but we cannot get them to understand
that what is occurring around them is often
a direct cause of one thing: them!
I had a young technician who had been
with us at least 3 years. She was smart, energetic, and extremely personable. She also
had a type AAA+ personality.
Her skills were stellar, her exams right on
the spot, and her exam times were appropriate. When she was in clinic, flow was never
an issue. The problem was I had staff begging for a break from her.
She was in everyone’s face, techs and doctors alike, continually with questions/comments like: “You love me most, don’t you?”
or “Aren’t I the cutest?”
I
E X T R AV E R T E D T O
NTH DEGREE
Some called her extra-extraverted to the nth
degree—but I knew otherwise. She was an
insecure person. Her constant need for attention was putting the wrong spotlight on
herself, causing a negative effect.
In most cases when there is a conflict between technicians because of personality issues, I provide ideas on how to work it out
and tell them, firmly, to move on. In this
case—I separated them.
Two technicians had come to me and
said, “She is a really good technician, but I
am mentally fried after working with her.
Please put me in another location away from
her for the next few weeks. I need a break.”
After developing a game plan, I sat down
with the AAA+ technician to get her to
understand the chaos she was creating
(whether intentionally or by mistake).
When you are dealing with someone’s
personality—their “core” being of what
makes them who they are or perceive who
they are—you need to tread carefully. You
can shake their foundation if you threaten
the base of belief of who they are.
There was a television show in the early
1970s, starring David Carradine, called “Kung
Fu.” It was about a young man’s search for
himself and truth. He was learning to seek his
inner self, that violence and chaos were not the
answer, and that he could control himself and his emotions
‘SHU T UP, LISTEN’
to ensure that he did good so
I started with: “Please listen
Managers can
that his impact on others was
to me with an open mind,
teach staff many
also one of peace and calm.
and understand I am doing
skills but often the
He had a mentor, and his
this in a kind manner, but
most difficult lesson
mentor called him “grasshopyou need to shut up.”
for employees to
per” as a term of endearment.
Her smile disappeared,
learn is they need to
Each week, a life lesson was
and then she smiled twice as
be aware of the chaos
imparted from the mentor to
wide and said: “I got it—OK.”
they consciously or
the young “grasshopper.”
“No, you need to shut
unconsciously create.
Carefully, I started: “When
up and get out of people’s
I was young tech, some might
faces. Stop asking, ‘Am I
say I was a force to be reckyour favorite?’ and give peooned with in the clinic—and not always in a
ple a breather. They all like you. They regood way. Maybe a bull in a china shop was
spect your skills. They know you pull your
weight. However, they have gotten to a point a better description.
“I wanted everyone to know I was there,
they want a break from you.”
and I wanted to be the best. Best at what? I
“What’s wrong with them?” she quietly
had no idea—just better than you.”
asked, shaking her head. “If they like me so
The young technician smiled at this.
much, why do they want me gone?”
“They don’t want you ‘gone’—they want
‘BACK OFF ’
you away from them. You are a hyperactive
“I soon realized that work was not a popular
person on your fifth Red Bull of the day.”
place because I wasn’t happy when I was at
The smile was really gone, and my work
work. I didn’t think people worked as hard
began to help an excellent technician get off
as me. I didn’t think anyone did as good a
everyone’s “hit list.” Now, we could talk.
job at patient care as me.”
As a 50-something manager, trying to get
One day an older technician, someone
into the head of a 20-something technician,
I looked up to, pulled me aside and said: “I
my analogies are from a different time, my
am gonna pop you if you don’t back off!”
principles are from the past, and I have no
I was hurt, mad, worried—but I did listen.
clue what “drives” them.
During a long weekend, I realized I still
Force won’t work and understanding is imcould be the best at what I do, but I needed
possible. If I “mother” them, I’ll lose them. If I
to appreciate that others were equally imdo a stern lecture, the walls will come up.
portant—if not more important in some
cases—in the roles they performed because I
PE ACE A ND QUIET
couldn’t do their roles!
What everyone was looking for was a litMy new mantra became: Make a presence
tle peace and quiet. But in order to achieve
without anyone knowing I was present.
that, I needed her to obtain some confiThe technician looked at me, and I could
dence. She was desperately seeking re-affirsee she was listening.
mation all day long from her co-workers, as
well as from the physicians.
Continues on page 34 : Behavior
TAKE-HOME
33
34
July 1, 2015 :: Ophthalmology Times
practice management
BeHaVIoR
“How do I do that?” she quietly asked.
I replied: “You need to learn to walk a
mile on the beach—but leave no footprints.
BRIEF SUMMARY OF PRESCRIBING INFORMATION
Ocular Surgery
DUREZOL®
a topical corticosteroid, is indicated for the treatment
surgery.
Endogenous Anterior Uveitis
DUREZOL® Emulsion is also indicated for the treatment
of endogenous anterior uveitis.
DOSAGE AND ADMINISTRATION
Ocular Surgery
“You need to be able to sit peacefully, and
calmly, at times, so still that if a fly flew by,
you could reach out and catch it and the fly
would be shocked because it didn’t know
you were even there.
“When you are in clinic, you need to do
your job the best you can without diminishing the job someone else does. If there is a
any persistent corneal ulceration where a steroid has
been used or is in use. Fungal culture should be taken
when appropriate.
Nursing Mothers
It is not known whether topical ophthalmic
administration of corticosteroids could result in
Topical Ophthalmic Use Only
DUREZOL¨ Emulsion is not indicated for intraocular
administration.
quantities in breast milk. Systemically administered
corticosteroids appear in human milk and could
suppress growth, interfere with endogenous
corticosteroid production, or cause other untoward
Contact Lens Wear
DUREZOL¨ Emulsion should not be instilled while
wearing contact lenses. Remove contact lenses prior to
instillation of DUREZOL¨ Emulsion. The preservative in
DUREZOL¨ Emulsion may be absorbed by soft contact
lenses. Lenses may be reinserted after 10 minutes
following administration of DUREZOL¨ Emulsion.
ADVERSE REACTIONS
Adverse reactions associated with ophthalmic steroids
include elevated intraocular pressure, which may be
associated with optic nerve damage, visual acuity and
eye 4 times daily beginning 24 hours after surgery
postoperative period, followed by 2 times daily for a
week and then a taper based on the response.
eye 4 times daily for 14 days followed by tapering as
clinically indicated.
DOSAGE FORMS AND STRENGTHS
DUREZOL®
a sterile preserved emulsion for topical ophthalmic
administration.
CONTRAINDICATIONS
The use of DUREZOL® Emulsion, as with other
ophthalmic corticosteroids, is contraindicated in most
active viral diseases of the cornea and conjunctiva
including epithelial herpes simplex keratitis
(dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal disease
of ocular structures.
WARNINGS AND PRECAUTIONS
IOP Increase
Prolonged use of corticosteroids may result in
glaucoma with damage to the optic nerve, defects
be used with caution in the presence of glaucoma. If
this product is used for 10 days or longer, intraocular
pressure should be monitored.
Cataracts
Use of corticosteroids may result in posterior
subcapsular cataract formation.
Delayed Healing
The use of steroids after cataract surgery may delay
healing and increase the incidence of bleb formation.
In those diseases causing thinning of the cornea or
sclera, perforations have been known to occur with
the use of topical steroids. The initial prescription
and renewal of the medication order beyond 28 days
should be made by a physician only after examination
slit lamp biomicroscopy and, where appropriate,
Bacterial Infections
Prolonged use of corticosteroids may suppress
the host response and thus increase the hazard
of secondary ocular infections. In acute purulent
conditions, steroids may mask infection or enhance
existing infection. If signs and symptoms fail to
improve after 2 days, the patient should be reevaluated.
Viral Infections
Employment of a corticosteroid medication in the
treatment of patients with a history of herpes simplex
requires great caution. Use of ocular steroids may
prolong the course and may exacerbate the severity
of many viral infections of the eye (including herpes
simplex).
Fungal Infections
Fungal infections of the cornea are particularly prone
to develop coincidentally with long-term local steroid
application. Fungus invasion must be considered in
secondary ocular infection from pathogens including
herpes simplex, and perforation of the globe where
there is thinning of the cornea or sclera.
Ocular Surgery
Ocular adverse reactions occurring in 5-15% of
subjects in clinical studies with DUREZOL¨ Emulsion
included corneal edema, ciliary and conjunctival
hyperemia, eye pain, photophobia, posterior capsule
Pediatric Use
DUREZOL® Emulsion was evaluated in a 3-month,
multicenter, double-masked, trial in 79 pediatric patients
(39 DUREZOL® Emulsion; 40 prednisolone acetate) 0 to 3
years of age for the treatment of infammation following
cataract surgery. A similar safety profle was observed in
pediatric patients comparing DUREZOL® Emulsion to
prednisolone acetate ophthalmic suspension, 1%.
Geriatric Use
occurring in < 1% of subjects included application
site discomfort or irritation, corneal pigmentation and
striae, episcleritis, eye pruritus, eyelid irritation and
crusting, foreign body sensation, increased lacrimation,
macular edema, sclera hyperemia, and uveitis. Most of
these reactions may have been the consequence of the
surgical procedure.
A total of 200 subjects participated in the clinical trials
for endogenous anterior uveitis, of which 106 were
exposed to DUREZOL¨ Emulsion. The most common
adverse reactions of those exposed to DUREZOL¨
Emulsion occurring in 5-10% of subjects included
blurred vision, eye irritation, eye pain, headache,
increased IOP, iritis, limbal and conjunctival hyperemia,
punctate keratitis, and uveitis. Adverse reactions
occurring in 2-5% of subjects included anterior
photophobia, and reduced visual acuity.
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic E
shown to be embryotoxic (decrease in embryonic
and teratogenic (cleft palate and skeletal) anomalies
when administered subcutaneously to rabbits during
organogenesis at a dose of 1–10 mcg/kg/day. The
to be a teratogenic dose that was concurrently found
in the toxic dose range for fetuses and pregnant
females. Treatment of rats with 10 mcg/kg/day
subcutaneously during organogenesis did not result in
any reproductive toxicity, nor was it maternally toxic.
At 100 mcg/kg/day after subcutaneous administration
in rats, there was a decrease in fetal weights and
human doses of DUREZOL® Emulsion, since DUREZOL®
Emulsion is administered topically with minimal
Advertiser Index
Advertiser
Abbott Medical Optics
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, and Impairment of
Fertility
in vitro in the Ames
test, and in cultured mammalian cells CHL/IU (a
www.amo-inc.com
Alcon Laboratories Inc.
Page
CVTIP, CV2, 3, 5-6
13-14, 34, CV3
P: 800/862-5266
www.alcon.com
female Chinese hamsters). An in vivo micronucleus
ocular adverse reactions occurring in 1-5% of subjects
included reduced visual acuity, punctate keratitis,
DIaNNa e. GRaVeS, ComT, BS eD
Dianna Graves is clinical services manager at St. Paul Eye Clinic PA,
in 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.
been observed between elderly and younger patients.
Treatment of male and female rats with subcutaneous
mating did not impair fertility in either gender. Long
term studies have not been conducted to evaluate the
Animal Toxicology and/or Pharmacology
In multiple studies performed in rodents and
non-rodents, subchronic and chronic toxicity tests
as suppression of body weight gain; a decrease
in lymphocyte count; atrophy of the lymphatic
Bausch + Lomb
9-10
P: 800/227-1427 or
800/323-0000 (Customer Service)
www.bausch.com
Katena Products Inc.
21
P: 973/989-1600
F: 973/989-8175
www.katena.com
thinning of the skin; all of which were due to the
pharmacologic action of the molecule and are well
The NOEL for the subchronic and chronic toxicity tests
were consistent between species and ranged from
1–1.25 mcg/kg/day.
PATIENT COUNSELING INFORMATION
Risk of Contamination
This product is sterile when packaged. Patients should
be advised not to allow the dropper tip to touch any
surface, as this may contaminate the emulsion.
Use of the same bottle for both eyes is not
recommended with topical eye drops that are used in
association with surgery.
Marco
17, 19
P: 800/874-5274
OCuSOFT
CV4
P: 800/233-5469
www.ocusoft.com
Risk of Secondary Infection
becomes aggravated, the patient should be advised to
consult a physician.
Contact Lens Wear
DUREZOL® Emulsion should not be instilled while
wearing contact lenses. Patients should be advised to
remove contact lenses prior to instillation of DUREZOL®
Emulsion. The preservative in DUREZOL® Emulsion may
be absorbed by soft contact lenses. Lenses may be
reinserted after 10 minutes following administration of
DUREZOL® Emulsion.
Revised: May 2013
U.S. Patent 6,114,319
Manufactured For:
were not measured in the reproductive animal studies.
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
1-800-757‐9195
Manufactured By:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
or
Catalent Pharma Solutions
Woodstock, IL 60098
pregnancy has not been evaluated and cannot rule
out the possibility of harm, DUREZOL® Emulsion should
© 2014 Novartis
©2014 Novartis
magenta
cyan
yellow
black
®
Emulsion is administered to a nursing woman.
bottleneck occurring, quietly get in there to
help smooth it out without any fanfare or
attention grabbing. Be comfortable in your
own skin enough to tell someone else they
did a great job—without expecting it in
return.”
She was reflective for a bit, and then
smiled a little and she headed back to work.
She did listen.
Maybe some concepts transcend generations after all. ■
3/14
1/15
DUR14031JAD
DUR14090JAD
This index is provided as an additional service.
The publisher does not assume any liability for errors
or omissions.
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ES638274_OT070115_034.pgs 07.01.2015 22:34
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to the brief summary of Prescribing Information on adjacent page.
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© 2015 OCuSOFT, Inc., Rosenberg, TX 77471 USA
PUBLISHED AS A PROMOTIONAL SUPPLEMENT TO
5
JULY 201
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FUNDING AND CONTENT
ASSISTANCE PROVIDED BY
PUBLISHED AS A
PROMOTIONAL
SUPPLEMENT TO
JULY 2015
FUNDING AND CONTENT
ASSISTANCE PROVIDED BY
Dr. Durrie is a clinical
investigator for Alcon.
Dr. Gordon is a consultant for
Alcon, Avedro, and Presbia.
Dr. Slade is a consultant for
Alcon.
Dr. Stonecipher serves or
has served as a consultant/
advisor, employee, lecturer,
owner, patent and/or royalty
recipient, and/or a speaker
for Abbott Medical Optics;
Alcon; Allergan; Bausch &
Lomb; Endure Medical; Ista
Pharmaceuticals; LaserACE;
Nexis; Nidek; Oasis Medical
Inc.; Refocus Group, Inc.;
STAAR Surgical; and TLC Laser
Eye Centers.
Dr. Stulting is a consultant/
advisor for, receives lecture
fees from, and/or is a
stockholder in Abbott Medical
Optics; AcuFocus; Alcon
Laboratories, Inc.; Allergan;
Calhoun Vision, Inc.; Cambium,
LLC; EyeYon; Hoya Corporation;
NuLens; Optovue; TearLab;
and VisionCare Ophthalmic
Technologies.
This is a promotional supplement
supported by Alcon. Copyright
2015 and published by Advanstar
Communications Inc. No portion of
this publication may be reproduced
or transmitted in any form, by
any means, without the prior
written permission of Advanstar
Communications Inc. The views
and opinions expressed in this
supplement do not necessarily
reflect the views and opinions of
Advanstar Communications Inc. or
Ophthalmology Times.
TIPPING POINTS:
Topography-Guided Ablation
Reshaping Refractive Surgery
(
nyone who has read Malcolm Gladwell’s book, The Tipping Point, is familiar
with how a small change gains momentum to create a paradigm shift. Refractive
surgeons in the United States recently benefited from such a tipping point with
the September 2013 U.S. Food and Drug Administration (FDA) approval of
the WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser system—a topography-guided
refractive treatment that shifts both the practice and the outcomes of LASIK.
Our panel faculty members, all of whom participated in the clinical trial leading to the 2013
FDA approval of topography-guided LASIK in the U.S., discussed details of the study. They
shared lessons they learned and other recommendations regarding wavefront treatment, and
in particular, topography-guided LASIK and Wavefront Optimized® aberration treatment
strategies. These are treatment strategies that, Dr. Gordon explains, “make the cornea a more
prolate surface, regularizing it—essentially smoothing out the lumps and bumps that affect the
quality of vision,” resulting in correction of any refractive error as well as also creating a better
focusing surface on the cornea.
FACULTY
R. DOYLE STULTING, MD, PHD, is director of the Stulting
Research Center in Atlanta, GA, and a referral ophthalmologist
for Woolfson Eye Institute. He is past president of the
American Society of Cataract and Refractive Surgery
(ASCRS) and holds academic appointments as emeritus
professor of ophthalmology at Emory University in Atlanta
and as adjunct professor of ophthalmology at Moran Eye
Center at the University of Utah in Salt Lake City.
STEPHEN SLADE, MD, specializes in presbyopia
correction as a founding partner of Slade & Baker
Vision Center in Houston, TX. He is a fellow of both the
American Academy of Ophthalmology (AAO) and the
American College of Surgeons, was elected president of
the American College of Ophthalmic Surgery in 2011, and
is chairman of the board of directors for the AmericanEuropean Congress of Ophthalmic Surgery.
KARL STONECIPHER, MD, serves as medical director of
TLC Greensboro and clinical assistant professor at the
University of North Carolina. He maintains membership in
AAO, ASCRS, and the International Society for Refractive
Surgery (ISRS).
DANIEL DURRIE, MD, is a board-certified ophthalmologist
and founder and president of Durrie Vision in Overland
Park, KS. As clinical professor and director of refractive
surgery services at the University of Kansas Medical
Center, he has directed the fellowship program in
ophthalmic refractive surgery since 1987. Dr. Durrie
founded and served as medical director of the Lions Eye
Bank of Nebraska as a founding member of the Omaha
Sunrise Lions Club. He has also served on the board of
directors of ISRS and is involved in numerous clinical
trials.
MICHAEL GORDON, MD, is board certified by the
American Board of Ophthalmology and practices with
Gordon Weiss Schanzlin Vision Institute in San Diego, CA.
He was a founding board member of the International
LASIK Institute and a member of the medical advisory
board for IntraLase. Dr. Gordon is also a member of AAO,
ISRS, ASCRS, the American Medical Association, and the
San Diego County Medical Association, and is a medical
advisory board member and investigator for Anamed.
Topography-Guided LASIK:
The Best Refractive News in a Decade
Many refractive surgeons believe that
the recent FDA approval of treatment
with the WaveLight® topography-guided
custom ablation treatment (T-CAT)
software and ALLEGRETTO WAVE®
Eye-Q Excimer Laser system may be the
most exciting refractive news in a decade.
Excimer laser ablation was discovered
in 1980, and over the last three and a
half decades eye surgeons have guided
the evolution of laser-assisted in situ
keratomileusis to the point where LASIK
has not only turned into the refractive
FIGURE 1. Wavefront Guided vs. Wavefront Optimized®3
technique of choice but has also become
common vernacular in the general
over time or if the patient had cataract surgery later on, you’ve
population. With the advent of the femtosecond laser in 2001,
these ultrafast lasers improved corneal-flap management, enabled got a customized cornea to a lens that’s no longer the same.
You want a regular cornea because when the patient has, say,
refractive surgical procedures based on intrastromal cutting
1
cataract surgery, these complex multifocal intraocular lenses
without excimer laser ablation, and ushered in the new century
with wavefront-guided and Wavefront Optimized® treatments.
(IOLs) will work better with a plain-optimized lens—and not
With FDA approval, the WaveLight® ALLEGRETTO WAVE®
some lens that has a bunch of irregularities or corrections for
Eye-Q Excimer Laser system promises to shift ophthalmologic
something that’s no longer there” (see Fig. 1).3
practice again by incorporating topographic measurements
WAVEFRONT-GUIDED TREATMENT
directly into the surgery. Its use for topography-guided LASIK
After mastering the complexity of the technology and the
is approved in conjunction with the WaveLight® ALLEGRO
behavior of the lasers, ophthalmologists began to recognize
Topolyzer™ topographer and T-CAT planning software.2 In his
experience, Dr. Gordon describes the benefits as providing “a
that instead of correcting all the aberrations, in certain
very precise laser treatment that gives us a precise correction of
circumstances, lasers were creating some. As a result,
the glasses prescription, but also gives us a better optical surface sometimes surgery actually induced optical aberrations.
to the cornea and therefore better quality vision.”
“We were causing visual problems on patients’ corneas that
we couldn’t even measure,” Dr. Stonecipher explains. “In my
RIDING THE WAVE: WAVEFRONT-GUIDED
clinical experience with a wavefront-guided technique, doctors
®
measure through the entire cornea with an aberrometry device—
AND WAVEFRONT OPTIMIZED
Wavefront technology—the mainstay of refractive treatment measuring how aberrated the eye is as an optical system.”4
The contemporary refractive surgical methods of the
for decades—takes a custom reading of the patient’s vision and
last two decades caused issues in the peripheral part of the
creates a custom treatment of the entire eye that, regardless of
where the problems originated, is executed on only the cornea. ablation. Dr. Stonecipher adds, “If you’re a -5 D and I laser you
somewhere on your cornea, there’s virgin untouched cornea
“If the problem was on the cornea, great,” Dr. Slade says,
where the laser hasn’t hit, and somewhere on your cornea
“but if it was in the lens, it would measure errors in the lens
there’s completely treated -5 D. In between, there’s -4.9 D, -4.8
and compensate for them on the cornea. As the lens changed
See pages 11-12 of this supplement for Important Product Information about WaveLight® Excimer Laser Systems.
Published as a promotional supplement to Ophthalmology Times®
3
FIGURE 2. WAVELIGHT® ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM
D, all the way down to -1.1 D to -.5 D, to virgin untouched
cornea. That transition zone was too abrupt, too harsh, and
the brain had trouble processing the signals. The engineers
figured out a way to blend that, to make that a softer, gentler
transition zone, and they called that Wavefront-Optimized®.”
WAVEFRONT OPTIMIZED® TECHNOLOGY
Our clinical challenge was, Dr. Stonecipher says, that custom
treatment wasn’t suitable for every patient. “We were making
changes on the cornea for the whole eye, making corrections
to the cornea to compensate for issues that may not be
originating from the cornea. These corrections could present
problems when patients return for cataract surgeries and other
procedures.”
In Wavefront Optimized® surgery, Dr. Durrie explains, “In
my experience, you take your best manifest refraction from
multiple data points you’ve measured on the patient then the
laser will optimize the amount of aberration that it’s going to
treat based on past data experience. There are some patients
who have distortions that are approved for wavefront-guided
surgery using a wavefront diagnostic instrument. We’ve seen
very good results when people have a lot of higher-order
aberrations on their preoperative wavefront measurement.
In the clinical trial, we saw patients with topography
abnormalities—asymmetries in their topography—for whom
the surgeon would benefit from having the laser direct the
treatment based off the topography instead of either the
wavefront-guided technique or the manifest refraction [i.e.,
Wavefront Optimized®].”
4
TIPPING POINTS: Topography-Guided Ablation Reshaping Refractive Surgery
TOPOGRAPHY-GUIDED LASIK VS WAVEFRONT TREATMENT
According to Dr. Stulting (medical monitor T-CAT study),
topography-guided LASIK has several advantages over
wavefront-guided treatment:
s)TISBASEDONMEASUREMENTOFELEVATIONATMOREPOINTS
on the cornea than wavefront treatments;
s)TISNOTDEPENDENTONPUPILSIZE
s)TISNOTAFFECTEDBYPUPILCENTROIDSHIFTWITHCHANGE
in pupil diameter;
s)TISNOTSUSCEPTIBLETOLENTICULARABERRATIONSOR
accommodation;
s)TISNOTAFFECTEDBYVITREOUSOPACITIES
s)TCANMEASURECORNEASWITHOPACITIESLIKESCARSOR
previous radial keratotomy);
s)TISNOTCONFUSEDBYHIGHLYABERRATEDCORNEAS
s)TCANMOREEASILYCORRECTPERIPHERALCORNEALABNORMALITIES
and
s)TADDRESSESHIGHORDERABERRATIONSWHERETHEYPRIMARILY
arise—at the cornea.5
TOPOGRAPHY-GUIDED TREATMENT
Unlike wavefront techniques that address aberrations in the
entire optical path, topography-guided LASIK measures the
topography of the corneal irregularities. The treatment then
incorporates both the refractive error of the eye (i.e., vision)
and corneal irregularities into the custom laser ablation for
myopic and myopic astigmatism.6 The topographer sends
the topography data with all the cornea’s irregularities to the
excimer laser, which then ablates the cornea according to
those irregularities (see Fig. 2).7
Topography-Guided LASIK: The FDA Study
In 2009, Alcon convened an FDA study
with R. Doyle Stulting as medical monitor. The study design was a multicenter,
phase III trial using the WaveLight®
ALLEGRETTO WAVE® Eye-Q Excimer
Laser system and T-CAT software for
the treatment of manifest and corneabased myopic optical errors, and study
results were impressive. Nearly 93%
of all study eyes achieved a UCVA of
20/20 or better, and 68.8% of all eyes
TABLE. Safety results up to 12 months.
achieved a UCVA of 20/16 at three
POSTOPERATIVE RESULTS
months postoperatively. A total of 93% of the T-CAT LASIK
The results in Dr. Gordon’s FDA clinical trial patients have
eyes had a UCVA of 20/20 or better at 3 and 12 months postbeen impressive, with patients achieving at least 20/20 reachoperatively. Nearly one-third of the eyes treated for myopia
with T-CAT LASIK (78/247, 31.6%) achieved a distance UCVA ing into the mid-90% range. “We had over 80% 20/16 or better
and 40% to 50% were in the 20/12 range. This is an FDA
of 20/12.5 or better, and over two-thirds of the eyes (170/247;
clinical trial where we were not able to use or adjust for any
68.9%) were seeing 20/16 or better without correction at 3
kind of nomogram corrections. I think from the standpoint of
months postoperatively. Symptoms traditionally associated
with LASIK (glare, halos, difficulty driving at night, light sensi- accuracy, this is something we haven’t seen, particularly in an
tivity, and eye dryness) improved after T-CAT LASIK with the FDA clinical trial—40% of the patients improved their vision
best spectacle corrected postoperatively. Better vision—uncorALLEGRETTO WAVE® Eye-Q Excimer Laser.8
Visual symptoms after the procedure were generally mild
rected—than they had with correction before the surgery. It’s
and continued to improve with time. In fact, no visual symppretty impressive. I think we have a better way to treat, and I
toms were rated as “marked” or “severe” at three months after
think we have the potential to give us happier patients.”
surgery and beyond, and 98% of the patients said they would
Beyond the typical measurements of uncorrected vision,
6
have the topography-guided procedure again. Other study
Dr. Durrie notes that the clinical trials provided extremely good
results demonstrated refractive predictability, efficacy, and safety
results from a symptom-improvement standpoint as well. Study
comparable to other treatment modalities, such as Wavefront
patients reported fewer halo, glare, and night vision problems
Optimized® and wavefront-guided treatments, and results were
than they had before. Dr. Durrie says, “In general, the patients
9
similar to those reported with other topography-guided systems.
had better symptoms after surgery than before.” Although
In addition, topography-guided LASIK induced fewer higherpatients with dry eyes were excluded from his sampling, Dr. Dur10
order aberrations compared to other treatment modalities.
rie notes that study patients did not develop dry eyes postoperaClinical outcomes showed not only excellent results based
tively, which is a common result from conventional LASIK.
on classical parameters (such as visual acuity, accuracy of
refraction, etc.), but according to Dr. Stulting, also on subjective assessments of visual quality, improved BSCVA, excellent
postoperative UCVA compared to preoperative BSCVA, and
subjective satisfaction with results.
SAFETY SUMMARY
The clinical trial revealed an excellent safety profile, with only
one eye losing two lines of BSCVA at one year after surgery,
which resolved one month later (Table).3,8
FIGURE 3A: Summary of Refractive Outcomes – Mean Values.
5
FIGURE 3B: Summary of Cumulative Postoperative Uncorrected
Visual Accuity (Early Treatment Diabetic Retinopathy Study).
FIGURE 3C: Postoperative Uncorrected Visual Accuity Compared to
Preoperative Best Spectacle Corrected Visual Accuity (Change in Lines).
FIGURE 3D: Visual Symptoms as Measured Preoperatively and Again at Three Months Postoperatively.
Preoperative complaints of decrease in light
sensitivity, decrease in complaints of difficulty
driving at night, decrease in reading difficulty,
and glare all showed statistically significant
improvements in the severity of these visual
symptoms in the T-CAT LASIK treated eyes.8
Dr. Gordon says, “We’re seeing a very precise
laser treatment that gives us a precise correction of the glasses prescription but gives
us a better optical surface to the cornea and
therefore better quality vision.”
CONCLUSIONS
As illustrated in Figures 3A-E and noted in
the FDA Summary of Safety and Effectiveness
Data approval report, the clinical trial results
6
FIGURE 3E: The following
complications occurred in
*1% of eyes3,8,:
At 3 months (n=247)
s&OREIGNBODYSENSATION
ATMONTHEYES
s$RYEYESREQUIRING
PUNCTALPLUGSOR
PRESCRIBEDUSEOFOCULAR
LUBRICANTSEYES
At 12 months (n=230)
s$RYEYESREQUIRING
PUNCTALPLUGSOR
PRESCRIBEDUSEOFOCULAR
LUBRICANTSEYES
showed that topography-guided primary LASIK
using the T-CAT algorithm and the WaveLight®
ALLEGRETTO WAVE® Eye-Q Excimer Laser
provided3, 8:
t&YDFMMFOU6$7"XJUIPGFZFTTFFJOH
20/16 or better and 35% of eyes seeing 20/12.5
or better at one year;
t"TJHOJĕDBOUJNQSPWFNFOUJOTVCKFDUJWF
quality of vision;
tPGFZFTXJUIQPTUPQFSBUJWF6$7"CFUUFS
than or equal to preoperative BSCVA;
t&YDFMMFOUTBGFUZXJUIPOMZPOFFZFMPTJOHUXP
lines of BSCVA at one year that resolved one
month later; and
t"QSPDFEVSFUIBUPGQBUJFOUTXPVME
have again.
Treatment Techniques and Strategies
CORNEAL ABERRATION NEUTRALIZATION
Ideally, surgeons want to neutralize corneal aberrations,
Dr. Slade says. The goal isn’t to customize a cornea to
compensate for deficiencies in the rest of the eye, but to
modify a cornea’s inherent irregularities to create a spherical
lens. “You want to customize the cornea to a non-custom
shape. You want the cornea to be a -2.” Topography-guided
LASIK does this, Dr. Slade notes in his experience with the
T-CAT FDA trial, by “actually directly linking a topographer—
which is taking tens of thousands of data points—to the laser
and doing a custom ablation on the cornea. That’s what this
software does; it leaves you with a custom treatment but not a
customized cornea.”
Such corneal aberration neutralization techniques, by which a
surgeon treats and essentially neutralizes the actual irregularity
on the cornea without treating for any other issue within
the eye, “is a logical way to treat a cornea,” Dr. Slade notes,
“especially considering that everybody will need cataract
surgery eventually, and so many of our Baby Boomers need it
now.”
With topography-guided LASIK, “you’re taking abnormally
shaped corneas and making them more regular, with the
outcome being a better optical surface.” Dr. Gordon notes
that wavefront-guided treatments don’t provide appreciable
benefits “unless you have an RMS [root mean square] or
wavefront abnormalities in the range of 0.3 to 0.4 microns.
But I think everybody stands to benefit from topography.8
Only 15% or so of the population has, in a normal, untreated
state, a significant wavefront error that would make any
difference in either their treatment or their outcome.11 But
with topography-guided treatment, you’re making the cornea
a better focusing surface in addition to correcting whatever
refractive error you’re treating. You’re making the cornea
a more prolate surface and you’re regularizing the cornea,
meaning you’re taking lumps and bumps that can affect
the quality of the vision and you’re smoothing those out,”
essentially neutralizing the corneal aberrations.
surgeons, we’d like to be able to include those data into the
laser shot file if we think it’s appropriate for that patient.
That’s what this new system does, really; it takes our practice
to the next level. Instead of looking at the topography on a
piece of paper in your office, the WaveLight® ALLEGRETTO
WAVE® Eye-Q Excimer Laser topography system brings it
right into the laser so we can look at the data and the shot
pattern the laser would make and decide if we are going
to use that as topography-guided information, or if we are
going to use a wavefront-guided or a Wavefront Optimized®
surgery. So, there are three different ways we can choose to do
this on the WaveLight® laser, depending on what the patient
needs. It adds to our ability to do the very best surgery for
each individual patient.”
TIPPING POINT: MORE THAN THE LASER
Since wavefront-guided surgery was first approved in 2002,
few companies were investing the time to upgrade software
and lasers in the United States, and Dr. Durrie praises Alcon
for stepping up to the plate.
“I really admire the fact that Alcon was willing to bring this
technology to the United States because it has been available
worldwide for several years,” Dr. Durrie says. “We already
have the same lasers, so it is great for us to have the most
advanced software here, too. This is a big step forward to allow
us in the United States to have fuller access to the software
within our lasers.”
The technology’s success in the United States so far has been
impressive. “We’re just getting started with it [in the United
States],” says Dr. Slade. “We just got it approved, and already
the FDA data show better results than we’ve ever seen before.”
TOPOGRAPHY AND DECISION-MAKING
“We always look at the topography,” Dr. Durrie points out.
“That’s part of the screening for anyone that does high-level
excimer laser surgery. For years we’ve used topography to
judge who’s a good surgical patient and who isn’t. But as
7
Learning Curves and Other Caveats
SELECTING PATIENTS
Although Dr. Durrie’s experience with clinical trials has
yielded very impressive results, he notes that his team was
careful in their patient selection. “We didn’t enroll anyone in
the clinical trial who’d had previous surgery,” Dr. Durrie says.
Nor would Durrie recommend that surgeons who adopt this
technology stray into off-label treatment territories.
Prudence should guide when, and in which patients,
topography-guided LASIK should be used. Dr. Gordon says,
“It’s only approved for myopic astigmatic individuals, number
one, and it’s not approved for corneal abnormalities per se,
meaning to enlarge small optical zones, to re-center decentered
optical zones, and irregular astigmatism or irregular corneas.
“In the FDA trial, we saw with good patient selection, doing
the right procedures and the right diagnostics, we absolutely
get better vision than our patients have ever had, fewer dry
eyes, fewer symptoms,” Dr. Durrie says. “Unfortunately, people
still use old equipment, and they’re still not screening patients
properly or mining all the details of the nomograms. But we’ve
shown that if you do all the things you’re supposed to do, in
2014, in my clinical experience with topography, we should
be able to leave almost all the traditional problems of LASIK
behind us. And it’s not all technology—it’s the people that still
use technology that was approved over a decade ago. If we use
topography-guided LASIK appropriately on the appropriate
patients, we get fabulous results. We just need to make sure
that people get well educated on that.”
ENSURING DIAGNOSTIC ACUMEN
Dr. Stulting also emphasizes that independent treatment and
diagnostic components, such as acquiring topographic images
preoperatively and careful measurement of refractive error, are
enormously important.
Dr. Stonecipher repeats a cautionary tale: “Just like with
wavefront treatments, if you can’t get a good measurement,
if you can’t get a good diagnostic, you don’t want to use this
technology.” Dr. Stonecipher warns that, regardless of the
treatment approach (wavefront guided or topography), there
can still be roadblocks to obtaining good measurements,
such as dry eye, eyelid issues, complications with deep-set
eyes, lens opacification, attempting to enhance a premium
8
IOL, or problems using a multifocal lens.
To obtain excellent outcomes “like those in the FDA trials,”
Dr. Stonecipher says, “you have to have the diagnostic acumen
that makes sense, that has no error messages, that has no loss of
data in the middle because of dry spots, that has no lack of data
because the eye’s so deep-set that you can’t get a good picture.”
RESPECTING THE LEARNING CURVE
It’s also crucial that surgeons not underestimate the technology,
or their own learning curves, Dr. Durrie stresses. “Even though
everybody has topography devices in their offices, they probably
haven’t used the machines themselves for years. They delegated
it to the technicians. So, its importance might be dismissed: ‘Oh,
this is just a topography, my staff knows how to do that.’ But this
is different. This is topography guiding the laser, not just giving
you a diagnostic printout.”
There’s another learning curve that physicians need to
acknowledge and respect. “Physicians have to learn what
a good topography is for treatment. That’s a big change for
some. We had certain criteria in the study—a good mires, no
missing data, a certain amount of coverage, the pupil capture
had to be good,” Dr. Gordon says.
However, once a physician becomes accustomed to
understanding the parameters, the process is not that difficult.
“It’s like any new technology,” Dr. Gordon adds, stressing,
“it’s incumbent upon the physician to learn the technology
and start out slowly. If you have questions, make sure those
questions are answered before you use it. That said, I don’t
think it’s very difficult. It’s a very simple technique. It’s no
different than doing LASIK—except how you input the data.”
The surgeon also needs to be involved in that process,
Dr. Durrie says, “and not just say it’s the technician’s job to get
a good topography. They need to make sure they understand
what a good topography is and when you’re going to use it,
not just for diagnostic procedures but for actually guiding
your surgery.”
It’s critical that surgeons take advantage of the training
Alcon provides, and Dr. Durrie emphasizes that this is not
something they should delegate to their technicians or an
optometrist in the practice. “It’s garbage in/garbage out,”
Dr. Durrie says. “If you don’t have a good topography, you
won’t have a good topography-guided result. Alcon will teach
that very well when they do the trainings. But the surgeon
needs to really be involved in that training.”
Dr. Stonecipher says physicians should first use this
technology in those virgin corneas that have not been
touched. “You want to treat the patients who have not had
previous surgeries. First, learn the technology, get comfortable
with it, and see what it can do in your hands before you go
out and start working on all the people that you or someone
in your area treated. In training, I always say, bring in your
easier cases first so we can work through the nomograms and
you can see how the laser is going to respond to this. It’s much
easier to treat a -1 D or -2 D and see what adjustments you
need to make as opposed to treating a -10 D. Because a 10%
error in a -1 D is a 10th of a diopter whereas a 10% error in a
10 D patient is a full diopter. So, that’s the difference between
20/40 vision and 20/20 vision.”
The learning curve is not just that of the surgeon,
Dr. Stonecipher adds. It’s also that of the diagnostician. Success
is not only reliant on the surgeon and his or her capabilities, but
also on the technician and his or her capabilities, on appropriate
patient selection, and then on obtaining good pictures.
Better Clinical Patient Management
Dr. Stonecipher points out the practice management
considerations that physicians need to evaluate. “There’s cost.
There’s outcomes. And there’s flow,” Dr. Stonecipher says.
“How much does it cost me? How much does it help the
patient see better? And how can I get the patient in and out
the door quickly? And that’s from both the doctor’s and the
patient’s standpoints. There are certain people in the world
who believe that everyone should have a topography-guided
treatment. Their whole point is, if we have the capability to do
that, let’s fix what’s on everybody’s cornea.”
Incorporating topography-guided LASIK could help physicians
better clinically manage their patients, Dr. Stulting says. “In the
T-CAT trial, our experience was that it offered the likelihood of
improving UCVA compared to preoperative BSCVA,” Stulting
notes, “reducing visual symptoms compared to preoperative
levels, eliminating dependence on glasses and contact lenses.
The technique requires an understanding of the principles of
T-CAT, meticulous care in acquiring topographic images
preoperatively, and careful measurement of refractive errors,
in addition to the normal skills required to perform LASIK.”8
TIPPING POINT: LESSONS FROM OVERSEAS
“Topography-guided LASIK has been used outside the United
States for quite some time,” Dr. Stonecipher says, and there’s
been an advantage to watching the technology used elsewhere
“because we get to learn what patients it works in or doesn’t
work in.” In other countries, its successful applications beyond
the current FDA approval shows that it is effective and well
tolerated in treating highly aberrated eyes and simultaneous
topography-guided ablations with collagen cross-linking for
keratoconus, which is not approved in the United States.12,13
Observing those abroad using the technology in their practices
has “shown us how to use and improve this technology—how
to get the best FDA results that have ever been published in
regard to outcomes in the treatments available.”
The recent approval, then, represents a clear paradigm shift
and the tipping point where refractive surgery in the United
States is concerned. Dr. Stonecipher says, “T-CAT treatment
may help us uniquely treat the cornea of every patient. We
can take a picture and treat based on a specific anatomy. A fair
number of investigators outside the United States have elected
to use the technology in every patient.”
Dr. Slade adds that the clinical trial results “were better
than any study we’ve done through the FDA. It has passed
the FDA test, but it’s important to note that it’s been approved
overseas” for some time now. And that’s been one of the very
few advantages of coming late to the table with approvals,
Dr. Slade points out. “You can see where other countries are
going with it. A lot of physicians overseas are using this as
the primary way of treating patients. There’s an advantage to
letting the overseas docs and patients do the ‘field trials’ and
figure out what to do and what not to do with this technology.”
TIPPING POINT: LASER SPEED AND
IMPROVED RECOVERY TIMES
Because the technology also brings improved recovery times,3
Dr. Stonecipher believes it paves the way for improved clinical
management of patients. “What’s happening that many folks
9
don’t take into account,” Dr. Stonecipher says, “is that lasers
are faster. They [United States-based refractive surgeons] had
a 500-hertz laser. Outside the United States, they have access
to a 1,000-hertz laser. The faster I can treat you, the less time I
have that flap off, the less time there is for swelling. So my 200
vs 400—the 400 is twice as fast.”
At first glance, that might not seem like a huge difference,
but Dr. Stonecipher offers some perspective. “Ask a bull rider
how long eight seconds is. If you’ve seen bull riding, eight
seconds is an eternity.”
ENSURING QUALITY TREATMENT FROM THE FIRST VISIT
Even with the new availability of this technology, the onus
remains on the surgeon to provide the best quality care and
treatment. First, Dr. Durrie says, “You have to make sure you
have a really good topography. Surgeons need to understand
that with topography-guided treatment, the information from
the topography device is going to be used in the stockpile the
surgeon uses to decide between topography-guided, wavefrontguided, or Wavefront Optimized® surgery. Just like with
wavefront-guided surgery, if you don’t have a good wavefront,
you can’t get good results with wavefront-guided surgery. So,
over the last 10 years we’ve learned how to look at the wavefront
and ask if it makes sense, if it’s a high-quality reading.”
Surgeons must also adhere to the guidelines, Dr.
Stonecipher stresses. “The approval of this laser system is for
normal eyes. But the thought process outside the United States
is that this is a great laser in certain instances of abnormal
eyes, too. So many researchers are using topography-guided
REFERENCES:
0ALANKER$6"LUMENKRANZ-3-ARMOR-&
&IFTYYEARSOFOPHTHALMICLASERTHERAPYArch
Ophthalmol.
53&OODAND$RUG!DMINISTRATION7AVELIGHT
!,,%'2%44/7!6%®%YE1%XCIMER,ASER
03http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/
ucm372964.htm
3TULTING2$4HEEVOLUTIONOFEXCIMERLASERVISION
CORRECTIONINTHE5NITED3TATES0RESENTEDAT
THE!NNUAL3YMPOSIUMAND#ONGRESSOF
THE!MERICAN3OCIETYOF#ATARACTAND2EFRACTIVE
3URGERY!3#23!PRIL"OSTON-!
7AVE,IGHT!'!LLEGRETTO7AVE4-%YE1!DDEN
DUMPROCEDUREMANUAL!#!47AVEFRONT'UIDED
TREATMENTS
!LCON5SERMANUALS7AVE,IGHT4OPOLYZER©
10
with cross-linking for keratoconus, which is not approved in
the United States. These same researchers will use topographyguided laser vision correction in the majority of their patients
for years and years because they get better outcomes with it.
More 20/20s, more 20/15s.”
Dr. Slade says that he probably would use a wavefront
treatment for a very young patient with an aberration in
the lens (a patient population for whom topography-guided
LASIK is not yet approved in the United States). Otherwise,
he would consider topography-guided LASIK exclusively,
foregoing contemporary techniques, in most patients.
“Patients would do better because it’s treating the actual
problem instead of treating the symptoms,” Dr. Slade says. “It
could easily become the major way we treat patients—like 95%
of the patients could have this done this way. And the key is
it’s treating the cornea, not treating the cornea for problems
that may lie elsewhere within the eye.”
According to Dr. Durrie, “This system allows the surgeon
more choices to treat the patients the very best. And there’s
nothing we like better than—when a patient decides to
trust us to do their elective eye surgery to get their very
best vision for a lifetime—to have all the tools possible
available at the time of the surgery.” ////
TECHNICAL SPECIFICATIONS14
WaveLight® Allegretto Wave® Eye-Q Laser
Technical Data and References
HTTPWWWALCONSURGICALCOMTECHNICALDATAASPX
6!2)/AND7AVE,IGHT®!NALYZER))
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http://eyewiretoday.com/view.asp?20131114alcon_wavelight_allegretto_wave_eye-q_
excimer_laser_approved_by_fda_for_topographyguided_lasik_treatments.
/H%INEACHAIN24OPOGRAPHYGUIDEDABLATION
Eurotimes
Surg Lasers Imaging
$URRIE$7ARING'%MERGINGTRENDSFORPROCEDURE
SELECTIONINCONTEMPORARYREFRACTIVESURGERY
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pdf2/P020050S012b.pdf
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http://bmctoday.net/crstoday/2012/10/article.
asp?f=topography-guided-laser-surgery
!LCON7AVE,IGHT®!LLEGRETTO7AVE®%YE1,ASER
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IMPORTANT PRODUCT INFORMATION ABOUT THE WAVELIGHT® EXCIMER LASER SYSTEMS
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See pages 11-12 of this supplement for Important Product Information about WaveLight® Excimer Laser Systems. Published as a promotional supplement to Ophthalmology Times®
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CTR does not prevent IOL dislocation

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