ReSTOR® +2.5 D IOL

Transcription

ReSTOR® +2.5 D IOL
CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
June 1, 2015 VOL. 40, NO. 9
SURGERY
DRUG THERAPY
Multifocal IOL
ReSTOR +2.5
D
IOL
EVOLUTION
OphthalmologyTimes.com
FOLLOW US ONLINE:
NEW! AcrySof
Drug Therapy
®
IQ
®
TRIAMCINOLONE
FOR UVEITIS
Introducing
a new direction in distance vision.
SHOWS PROMISE
Trifocal designs appear to target better intermediate
vision than bifocal diffractive MFIOLs in studies
IN VIEW
Now with
Slit lamp
photograph of the
trifocal diffractive
multifocal IOL
(FineVision
MicroF, PhysIOL).
The trifocal IOL
distributes 45%
of incoming light
to distance, 20%
to intermediate,
and 35% to near.
CHICAGO :: PATIENTS with noninfectious uveitis who were treated with a
single suprachoroidal injection of triamcinolone acetonide in a 6-month
phase I/II clinical trial exhibited im*
provements in best-corrected visual
acuity, said investigator Debra A. Goldstein, MD, Northwestern University Feinberg School of Medicine. The injection
was generally safe and well tolerated.
ACTIVEFOCUS™
optical design for
active-lifestyle patients.
(Image courtesy
of Rudy M.M.A.
Nuijts, MD, PhD)
( See story on page 6 : Injection )
Drug Therapy
GENERICS MAY
BOOST ADHERENCE
Now you can take distance vision one step further.
IN GLAUCOMA
The new AcrySof ® IQ ReSTOR® +2.5 D IOL is designed to deliver sharp distance vision for your
ANN ARBOR, MI :: GLAUCOMA medmore
active-lifestyle
patients. Its new ACTIVEFOCUS™GHVLJQLVDQDSRGL]HGGLUDFWLYHRSWLFZLWKIHZHU
ication adherence
continues
to be a
major challenge for
someapatients,
steps,
centralwith
refractive zone for distance and increased negative asphericity.**1RZ\RXFDQRHUDQ
several studies having
reported
compliexcellent balance of vision for your more active patients.
By Cheryl Guttman Krader;
ogy, Maastricht University Medical Center, Maasance rates of only 50% or lower, said
Reviewed by Rudy M.M.A. Nuijts, MD, PhD,
tricht, The Netherlands.
Joshua D. Stein, MD, MS, University of
and Soraya M.R. Jonker, MD
Dr. Nuijts provided an overview of existing litMichigan School of Medicine. Though
*Active lifestyle patients participate in activities that require intermediate and distance vision
erature
on trifocal MFIOLs (not commercially availpatients
may
struggle
with
their
regisuch as golf, tennis, house cleaning and driving.
able in the United States), including a randomized,
MA AS T RICH T, T HE NE T HERL ANDS ::
mens for
various
reasons,
**Compared
to models
SN6AD1,
SN6AD3medication
and MN6AD1
IF THE ULTIMATE GOAL of implanting a controlled trial his group conducted comparing tricost remains a major factor. Quantifyfocal
bifocal diffractive MFIOLs.
multifocal IOL (MFIOL) is to achieve spectacle indeing the impact of cost on adherence
AcrySof
IQand
ReSTOR
CATARACT SURGERY
PRESBYOPIA-CORRECTING IOL
“Overall, the evidence suggests a trifocal MFIOL
pendence after cataract surgery, then choosing a lens
can be difficult, however. For instance,
with a trifocal diffractive optic may be more advan- provides slightly better intermediate vision than a
patients may be too embarrassed to
©admit
2015 Novartis
4/15 RES15029JAD
tageous than one with a bifocal diffractive design. bifocal MFIOL while maintaining good near and
to financial
burdens imposed
Such is a conclusion based on data from studies distance vision,” Dr. Nuijts said. “Nevertheless, the
by drug regimens, either when filling
investigating visual outcomes and optical perfor- incidence of optical phenomena, which is also conout research surveys or participating
mance with trifocal diffractive MFIOLs, said Rudy sidered a limitation of bifocal diffractive MFIOLs, apin focus groups.
®
( See story on page 8 : Adherence )
M.M.A. Nuijts, MD, PhD, professor of ophthalmol-
®
Advancing
pears similar with the bifocal and trifocal designs.”
( Continues on page 14 : Trifocal )
IMPORTANT PRODUCT INFORMATION FOR THE
ACRYSOF® IQ RESTOR® FAMILY OF IOLs
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.
INDICATIONS: The AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in
adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.
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. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye
at the close of surgery.
Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant
enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or
looking at small objects.
Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should
provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR®
IOLs.
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.
© 2015 Novartis 4/15 RES15029JAD-PI
CUTTING-EDGE ADVANCEMENTS
CLINICAL DIAGNOSIS
OphthalmologyTimes.com
FOLLOW US ONLINE:
Drug Therapy
TRIAMCINOLONE
FOR UVEITIS
SHOWS PROMISE
SURGERY
June 1, 2015 VOL. 40, NO. 9
DRUG THERAPY
Multifocal IOL
EVOLUTION
Trifocal designs appear to target better intermediate
vision than bifocal diffractive MFIOLs in studies
IN VIEW
Slit lamp
photograph of the
trifocal diffractive
multifocal IOL
(FineVision
MicroF, PhysIOL).
The trifocal IOL
distributes 45%
of incoming light
to distance, 20%
to intermediate,
and 35% to near.
CHICAGO :: PATIENTS with noninfectious uveitis who were treated with a
single suprachoroidal injection of triamcinolone acetonide in a 6-month
phase I/II clinical trial exhibited improvements in best-corrected visual
acuity, said investigator Debra A. Goldstein, MD, Northwestern University Feinberg School of Medicine. The injection
was generally safe and well tolerated.
(Image courtesy
of Rudy M.M.A.
Nuijts, MD, PhD)
( See story on page 6 : Injection )
Drug Therapy
GENERICS MAY
BOOST ADHERENCE
IN GLAUCOMA
ANN ARBOR, MI :: GLAUCOMA medication adherence continues to be a
major challenge for some patients, with
several studies having reported compliance rates of only 50% or lower, said
Joshua D. Stein, MD, MS, University of
Michigan School of Medicine. Though
patients may struggle with their regimens for various reasons, medication
cost remains a major factor. Quantifying the impact of cost on adherence
can be difficult, however. For instance,
patients may be too embarrassed to
admit to financial burdens imposed
by drug regimens, either when filling
out research surveys or participating
in focus groups.
( See story on page 8 : Adherence )
By Cheryl Guttman Krader;
Reviewed by Rudy M.M.A. Nuijts, MD, PhD,
and Soraya M.R. Jonker, MD
MA AS T RICH T, T HE NE T HERL ANDS ::
IF THE ULTIMATE GOAL of implanting a
multifocal IOL (MFIOL) is to achieve spectacle independence after cataract surgery, then choosing a lens
with a trifocal diffractive optic may be more advantageous than one with a bifocal diffractive design.
Such is a conclusion based on data from studies
investigating visual outcomes and optical performance with trifocal diffractive MFIOLs, said Rudy
M.M.A. Nuijts, MD, PhD, professor of ophthalmol-
ogy, Maastricht University Medical Center, Maastricht, The Netherlands.
Dr. Nuijts provided an overview of existing literature on trifocal MFIOLs (not commercially available in the United States), including a randomized,
controlled trial his group conducted comparing trifocal and bifocal diffractive MFIOLs.
“Overall, the evidence suggests a trifocal MFIOL
provides slightly better intermediate vision than a
bifocal MFIOL while maintaining good near and
distance vision,” Dr. Nuijts said. “Nevertheless, the
incidence of optical phenomena, which is also considered a limitation of bifocal diffractive MFIOLs, appears similar with the bifocal and trifocal designs.”
( Continues on page 14 : Trifocal )
Recognize both.
Recommend AcrySof IQ Toric IOL.
®
CONFIDENCE
For important safety information, please see adjacent page.
© 2013 Novartis 2/13 TOR13020JAD
Recommend the AcrySof ® IQ Toric IOL
for your astigmatic cataract patients.
JUNE 1, 2015 :: Ophthalmology Times
contents
3
22
6
10
Drug Therapy
Special Report
Practice Management
6 TRIAMCINOLONE SHOWS
PROMISE FOR UVEITIS
10 ANTERIOR VERSUS
POSTERIOR CHAMBER IOL
29 THE ‘PERFECT’ CLINIC
Average improvement in BCVA
at week 26 was nearly 3 lines
Also In This Issue
Surgeons should be aware of variety
of techniques in aphakic eyes lacking
capsular support
4 EDITORIAL
A lesson from the sports world:
Sometimes good for all is better
than perfect for one
24 MARKETPLACE
What’s Trending
allow the lens to rotate.
See what the ophthalmic community is reading on
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www.AcrySofIQTORIC.com
CAUTION: Federal (USA) law restricts this
device to the sale by or on the order of a
physician.
INDICATIONS: The AcrySof® IQ Toric posterior chamber intraocular lenses are intended
for primary implantation in the capsular bag
of the eye for visual correction of aphakia and
pre-existing corneal astigmatism secondary
to removal of a cataractous lens in adult
patients with or without presbyopia, who
desire improved uncorrected distance vision,
reduction of residual refractive cylinder and
increased spectacle independence for distance vision.
WARNING/PRECAUTION: 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. Toric IOLs
should not be implanted if the posterior
capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy
is planned. Rotation can reduce astigmatic
correction; if necessary lens repositioning
should occur as early as possible prior to lens
encapsulation. All viscoelastics should be removed from both the anterior and posterior
sides of the lens; residual viscoelastics may
Optical theory suggests that high astigmatic
patients (i.e. > 2.5 D) may experience spatial
distortions. Possible toric IOL related factors
may include residual cylindrical error or axis
misalignments. Prior to surgery, physicians
should provide prospective patients with a
copy of the Patient Information Brochure
available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof® IQ Toric Cylinder
Power IOLs.
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.
© 2013 Novartis 2/13 TOR13020JAD
4
JUNE 1, 2015 :: Ophthalmology Times
editorial
JUNE 1, 2015 ◾ VOL. 40, NO. 9
CONTENT
Equal pay for equal work
Bargaining power does not equate to a level playing field
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
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“What is negotiation but the accumulation
of small lies leading to advantage?”
—Felix Dennis
“ELLEN PAO IS SWIFTLY emerging as the new face of feminism in the United
States,” declared a recent article in the business/finance literature.
That name may ring a bell to some readers
because of Pao’s recent lawsuit against her former employer. She sued for $160 million ($16
million in lost wages and $144 million in punitive damages) after not being promoted within
one of Silicon Valley’s biggest venture capital
firms, claiming that the decision was the result
of gender discrimination.
The lawsuit received a lot of attention in the
press because of the facts that sounded less like
something from the business school literature
and more like something in “Playboy” (or so I
imagine).
Numerous salacious details came out in the
testimony, including romantic trysts and employees wearing bathrobes showing up at their
colleagues’ hotel room doors. These are the
details inquiring minds want to know. The
jury ultimately weighed in by deciding that
the plaintiff had not been a victim of gender
discrimination.
TAKING TALKS
OFF THE TABLE
Pao is currently the interim chief executive officer of Reddit, an entertainment, social networking, and news website. What is attracting attention and some praise is Pao’s establishment of
a new policy that no longer allows new hires to
negotiate their salaries.
“We come up with an offer that we think is
fair . . . we aren’t going to reward people who
are better negotiators with more compensation,” Pao explained.
In an article about this change, “Pao defended her move based on studies that have
shown that when women negotiate, they don’t
fare as well as their male counterparts.”
According to a study by Linda Babcock, a
professor at Carnegie Mellon University, “when
women negotiate, both men and women are
less likely to want to work with them. Men, on
the other hand, are much more respected for
their negotiation skills. For women, it’s generally a lose-lose situation.”
W H AT’S FAIR IS FAIR
I agree that this approach has a lot of merit.
Why shouldn’t people earn a fair degree of
compensation, in a transparent manner, for
their work, and why should a company that has
ten people doing the same job be paying them
ten different amounts?
In an ophthalmology practice or academic
department, should hiring a new associate resemble a visit to a car dealership, in which an
applicant willing to delay and engage in protracted discussions be rewarded financially relative to his or her equally well-trained and productive colleague?
How about a system that clearly states how
base and bonus compensation are determined
and let employees—through their actions and
measurable productivity—determine their compensation, irrespective of the number of X
chromosomes they may possess? Q
Chief Medical Editor Peter J. McDonnell, MD
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Reference
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2014 :: Ophthalmology Times
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Chief Medical Editor
Peter J. McDonnell, MD
Wilmer Eye Institute
Johns Hopkins University
Baltimore, MD
Anne L. Coleman, MD
Joan Miller, MD
Jules Stein Eye Institute, UCLA
Los Angeles, CA
Massachusetts Eye & Ear Infirmary
Harvard University
Boston, MA
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Harvard & Tufts Universities
Boston, MA
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Wilmer Eye Institute, Johns Hopkins University
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University of Toronto
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University of Colorado,Denver
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New York Eye & Ear Infirmary, Beth Israel Medical Case Western Reserve University
Center, Albert Einstein College of Medicine
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How to Contact Ophthalmology Times
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6
JUNE 1, 2015 :: Ophthalmology Times
drug therapy
Triamcinolone acetonide
for uveitis shows promise
Average improvement in best-corrected visual acuity at week 26 was nearly 3 lines
By Nancy Groves; Reviewed by Debra A. Goldstein, MD
also had complete resolution of macular edema,
atients with noninfectious uveitis which persisted for the 6 months of the study.
who were treated with a single
suprachoroidal injection of triamNOV E L A SPE C T S OF ST U DY
cinolone acetonide in a 6-month The novel aspects of this trial were the injection
phase I/II clinical trial exhibited site and the injector system, Dr. Goldstein said.
improvements in best-corrected
Animal data on suprachoroidal injections sugvisual acuity (BCVA), said in- gest a better effect can be achieved with a lower
vestigator Debra A. Goldstein, MD.
dose of triamcinolone than is typically used for
The injection was generally safe and well intravitreal injection, which potentially could
tolerated, said Dr. Goldstein, professor of oph- reduce the risk of side effects. Also, because the
thalmology and director, Uveitis Service, North- drug does not enter the vitreous cavity, patients
western University Feinberg
are unlikely to experience
School of Medicine, Chicago.
the floaters commonly seen
Dr. Goldstein helped design the
after intravitreal steroid inResults of a 6-month
trial, in which eight patients
jection. The suprachoroidal
phase I/II clinical trial
at three U.S. centers received
injection also may last lonof suprachoroidal injection
an injection of a commercially
ger than intravitreal injecof triamcinolone for
available formulation of triamtions, which typically last
noninfectious uveitis
cinolone acetonide using a proonly 3 to 4 months.
showed the treatment was
prietary microinjector (ClearAnimal data also suggest
safe and well tolerated.
side Biomedical Inc.)
the drug can partition well
No serious adverse events
by suprachoroidal injection,
related to the drug or the inwith almost no drug seen in
jection were observed over the course of the the anterior segment, thereby reducing the risk
trial. No patients developed or had progres- of cataract and glaucoma, and concentrating
sion of cataract and none had an elevation in primarily in the outer retina and choroid, the
IOP. However, all eight patients experienced areas needed to improve visual acuity.
an adverse event of some sort, most commonly
With the microinjector system, the injection
pain or redness at the injection site.
is performed 4 mm posterior to the limbus with
Although the trial was not designed to evalu- a 30-gauge needle, which is customary for inate efficacy, the limited data showed good re- traocular injections. However, the needles are
sults. Four patients showed improvements of much shorter than usual, Dr. Goldstein said.
≥2 lines of BCVA as early as week 4.
Investigators had a choice of needles of 850,
“This persisted for all 26 weeks of the study, 900, 950, or 1,100 μm in length. For each eye,
suggesting that the injection does last a long the appropriate needle was selected by meatime,” Dr. Goldstein said. The average was suring scleral thickness at the injection site
close to 3 lines of improvement at week 26.
with ultrasound. The drug was injected beSeven of the eight patients had macular tween the sclera and the choroid.
edema and four also had vitreous haze. One
Enrollment has begun for a phase II study
of the study endpoints was a 20% reduction of the suprachoroidal injection, with a larger,
in macular edema, which is generally consid- multicenter phase III trial beginning shortly. ■
ered a valid endpoint.
By week 1, 40% of patients had met this target; 71% reached the endpoint by week 4, and
DEBRA A. GOLDSTEIN, MD
67% of eyes retained the reduction in macular
E: [email protected]
edema by the end of the study. Some patients
Dr. Goldstein is a consultant for Clearside Biomedical Inc.
CHICAGO ::
P
Procedure
4 mm posterior to limbus
Ultrasound assessment of scleral thickness
850, 900, 950, or 1,100 μm; 30-g needle
0.80 mm
(FIGURE 1) Transverse B-scan ultrasound
illustrating measurement of scleral thickness prior
to injection. (Images courtesy of Debra A. Goldstein, MD)
TAKE-HOME
caption_mug
(FIGURE 2) Ultrasound images taken immediately
after suprachoroidal injection of triamcinolone,
illustrating drug in the suprachoroidal space and
in the choroid.
Pre-injection
6 months’ follow-up
(FIGURE 3) Patient with chronic uveitis and cystoid
macular edema (CME). The CME resolved 4 weeks
after injection. Top photo illustrates the CME before
injection; bottom photo demonstrates persistence
of the steroid effect 6 months after the injection.
LET’S KEEP SOMETHING
STRAIGHT ABOUT AREDS2
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contains the exact ingredient dosages
recommended by the National Eye Institute†
based on the evidence from the AREDS2 study.1,2*
Get patient samples and education
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†
For patients with moderate to advanced age-related macular degeneration.
*This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.
PreserVision. Exactly.
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2014:1-5. 2. Chew EY, Clemens TE, SanGiovanni JP, et al. Lutein and zeaxanthin and omega-3 fatty
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PreserVision is a trademark of Bausch & Lomb Incorporated or its affiliates. AREDS2 is a
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SEE BETTER. LIVE BETTER.
8
JUNE 1, 2015 :: Ophthalmology Times
drug therapy
Adherence to drug regimens
may increase with generics
Switching therapies may help some patients with high co-payments, racial minority groups
By Lynda Charters; Reviewed by Joshua D. Stein, MD, MS
ANN ARBOR, MI ::
GLAUCOMA MEDICATION adherence continues to be a major challenge for some
patients, with several studies having reported
compliance rates of only 50% or lower, said
Joshua D. Stein, MD, MS.
Though patients may struggle with their
regimens for various reasons, medication cost
remains a major factor, said Dr. Stein, associate professor, Department of Ophthalmology
and Visual Sciences, University of Michigan,
and director, Center for Eye Policy and Innovation, W.K. Kellogg Eye Center, Ann Arbor, MI.
Quantifying the impact of
cost on adherence can be difficult, however, he explained.
For instance, patients may
be too embarrassed to admit
to financial burdens imposed
by drug regimens, either when
Dr. Stein
filling out research surveys or
participating in focus groups.
Prostaglandin analogues—among the most
frequently prescribed and most effective drugs
to treat open-angle glaucoma—require only
once-daily dosing and have minimal side effects. However, they are also among the most
expensive of the glaucoma drugs, said Dr. Stein,
adding that some patients pay more than $100
out of pocket each month.
LATANOPROST AS GENERIC
With the commercial availability of the first
generic prostaglandin analogue, i.e., latanoprost, in 2011 in the United States, some patients saw a considerable and potential reduction in financial burden.
In light of this, Dr. Stein and colleagues conducted a study to determine if the availability
of latanoprost for open-angle glaucoma had an
effect on patient adherence. Specifically, was
there an impact to patients’ drug regimens
after they switched from a brand-name drug
to a generic counterpart, compared with other
patients with glaucoma who continued taking
a brand-name prostaglandin analogue?
Investigators evaluated data from a large,
managed-care database of patients aged 40 or regression analysis that were associated with
more years who received a diagnosis of open- improved adherence. Results showed that paangle glaucoma and were followed in the plan tients remaining on a brand-name drug had a
from September 2009 to December 2012. All 28% reduced odd of improved adherence and
patients in the medical plan were also enrolled a 39% higher odd of worsening of adherence.
Factors associated with improved adherence
in the pharmacy plan.
include use of generic latanoPatients had at least one
prost in the post-introductory
record of a prescription for a
period, higher insurance co-paybrand-name prostaglandin anAdherence to
ments in the pre-generic period,
alogue before 2009. The study
glaucoma medication
lower insurance co-payments
thus avoided patients who were
is a major challenge
in the post-generic period, and
newly treated during the first
for some patients due
black race.
18 months of the study period.
to a variety of factors,
Variables associated with
All patients were taking a
including financial
reduced rates of adherence inbrand-name prostaglandin anaburden. Making a
clude use of brand-name drugs
logue before the generic version
switch in treatment
throughout the study period,
of latanoprost became available.
from branded to
higher monthly insurance coPatients were excluded if they
generic drugs may
payments in the post-introduchad undergone a surgery or laser
make a difference
tory period, black race, and a lack
treatment for glaucoma.
for patients in certain
of visits to eye-care providers.
Investigators defined imcases.
Dr. Stein and co-investigators
proved adherence to medicasuggest ophthalmologists contion as an increase of 25% or
sider switching treatments for
more in the proportion of days
covered by a drug and worsening adherence patients who are not adhering to their glaucoma-medication regimens to a generic prodas a decrease of 25% or more, he explained.
A total of 8,427 patients met the study in- uct, if possible.
“This may be particularly helpful for paclusion criteria, with more than 2,000 patients
taking each of the three brand-name medica- tients with high medication co-payments and
tions—branded latanoprost (Xalatan, Pfizer for patients from racial minority groups,” he
Pharmaceuticals); bimatoprost (Lumigan, Aller- said. “Such persons may discontinue use of
gan); and travoprost (Travatan Z, Alcon Phar- their medical glaucoma treatment altogether
maceuticals)—before the introduction of ge- if they simply cannot afford the medications
they are prescribed.” ■
neric latanoprost to the market.
There was little change in the rates of medication adherence among patients who continued
Join the discussion on whether adherence
taking a brand-name product after the generic
can be increased with generics at
became available, Dr. Stein noted.
Facebook.com/OphthalmologyTimes
TAKE-HOME
S U B S E T, O T H E R FAC T OR S
“However, for a subset of patients who were
switched to generic latanoprost, adherence to
their initially prescribed, brand-name drug
was lower than average, yet subsequently increased substantially after the switch to the
generic product,” Dr. Stein said.
Of special interest were factors identified by
JOSHUA D. STEIN, MD, MS
E: [email protected]
Dr. Stein did not indicate any proprietary interest in the subject matter.
W H E R E A L L O F O P H T H A L M O LO GY M E E T S
LAS VEGAS
Posters
Products
Papers
Technology
Techniques
Trends
WHAT WILL YOU DISCOVER?
PROGRAM HIGHLIGHTS
Laureate Awardee
Bruce E. Spivey, MD
Jackson Memorial Lecture
Anne L. Coleman, MD, PhD
Dr. Allan Jensen & Claire Jensen
Lecture in Professionalism and Ethics
Carl Elliott, MD, PhD
Michael F. Marmor, MD Lecture in
Ophthalmology and the Arts
Edmund Morris, presidential historian
AAO 2015
November 14–17
Subspecialty Day
November 13–14
AAOE Program
November 14–17
REGISTRATION OPENS
June 24
Academy and AAOE Members
July 8
Nonmembers
Learn what you can discover
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The American Academy of Ophthalmology is accredited by
the Accreditation Council for Continuing Medical Education
to provide continuing medical education for physicians.
www.aao.org/2015
#aao2015
10
TECHNOLOGICAL ADVANCES IN
Special Report )
ADVANCES CONTINUE TO PROGRESS FOR PERFORMANCE OF INTRAOCULAR LENS IMPLANTS
IOLs
Avoid AC IOLs when . . .
Richard S. Hoffman, MD, recommended
avoiding anterior chamber (AC) IOLs if a
patient has glaucoma, a shallow anterior
chamber, insufficient iris tissue, or corneal
endothelial dystrophy.
(Images courtesy of Richard S. Hoffman, MD)
Contraindications
to Iris Fixation
Large iris defects
Iridoschisis
Iris atrophy
Aniridia
Active youth
> Suture tearing
> Suture slippage
NO CAPSULE SUPPORT:
ANTERIOR VERSUS
POSTERIOR CHAMBER IOL
Surgeons should be aware of variety of techniques
for aphakic eyes that lack capsular support
By Vanessa Caceres; Reviewed by Richard S. Hoffman, MD
A
EUGENE, OR ::
take-home
When considering
IOL implantation
options when there
is a lack of capsular
support, cataract
surgeons should use
the approach with
which they are most
comfortable. They
should also continue
to learn about new
available techniques.
broad familiarity of techniques
to implant an IOL in the absence of capsular support can
be a valuable addition to the
surgeon’s virtual toolkit, said
Richard S. Hoffman, MD.
Available options for managing cases where there is a lack of
capsule support include an anterior chamber (AC) IOL, a scleralfixated posterior chamber (PC) IOL, an iris-fixated PC IOL, and
intrascleral haptic capture, he noted.
“To date, no studies have shown that any one technique is superior to the others,” said Dr. Hoffman, clinical associate profes-
sor of ophthalmology, Casey Eye Institute, Oregon Health and Science University, Eugene.
Dr. Hoffman cited several studies that supported open-loop AC IOLs and that found this
approach posed no greater threat than PC IOLs
in the realm of visual outcomes in secondary
IOL implantation.1-3
However, some complications with AC IOLs
include pain, bullous keratopathy, angle-closure glaucoma, and chronic uveitis. A properly
sized, modern Kelman-style open loop AC IOL
may help avoid some of these complications
and is easily inserted, has a polished finish,
and flexible haptics, Dr. Hoffman said.
Dr. Hoffman recommended avoiding AC IOLs
if a patient has glaucoma, a shallow anterior
chamber, insufficient iris tissue, or corneal
endothelial dystrophy.
If implanting a scleral-fixated IOL, Dr. Hoffman advised operating temporally to reduce
astigmatism and using 9-0 Prolene or CV8
Gore-Tex. He did not recommend the use of
10-0 Prolene.
He said he also tries to avoid passing sutures
at 9 o’clock and 3 o’clock. Two-point fixation
is simpler, but four-point fixation allows for
greater stability and less lens tilt. Four-point
fixation can be associated with an increase in
bleeding due to twice as many suture passes
through the sclera, Dr. Hoffman said.
If using transscleral fixation, users should
bury, cover, or rotate scleral knots to prevent
conjunctival erosion and the risk for subsequent
endophthalmitis, Dr. Hoffman said.
Continues on page 12 : Capsule support
Down, Boy.
Help Tame Postoperative Ocular Inflammation
and Pain With LOTEMAX® GEL
Indication
LOTEMAX® GEL (loteprednol etabonate ophthalmic gel) 0.5% is indicated for the treatment of
post-operative inflammation and pain following ocular surgery.
Important Safety Information about LOTEMAX® GEL
2 ® GEL is contraindicated in most 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 diseases of ocular structures.
2 )&#&%,*&&)+ &*+)& *$0)*,#+ %#,&$. +$+&+&'+ %)-+* %- *,#
, +0% #*&- * &%+ *')&,+ *,*&)0*&)#&%)*&,#$&% +&)
2 *&&)+ &*+)& *$0)*,#+ %'&*+) &)*,'*,#)+)+&)$+ &%
2 *&*+)& *+)+)+*,))0$0#0# %% %)*+ % %&#&)$+ &%%
occurrence of perforations in those with diseases causing corneal and scleral thinning. The initial prescription
and renewal of the medication order should be made by a physician only after examination of the patient with
the aid of magnification, and where appropriate, fluorescein staining.
2 )&#&%,*&&)+ &*+)& *$0*,'')**+&*+)*'&%*%+,* %)*+1)&*&%)0&,#)
infection. In acute purulent conditions, steroids may mask infection or enhance existing infection.
2 *&&)+ &*+)& $ + &% %++)+$%+&'+ %+*. + *+&)0&)'** $'#/)(, )*)+
,+ &%*&&,#)*+)& *$0')&#&%+&,)*%/)++*-) +0&$%0- )# %+ &%*&
the eye (including herpes simplex).
2 ,%# %+ &%*&+&)%)')+ ,#)#0')&%+&-#&'& % %+##0
. +#&%+)$#&#*+)& ''# + &%,%,* %-* &%$,*+&%* )
in any persistent corneal ulceration where a steroid has been used or is in use.
2 + %+**&,#%&+.)&%++#%**.%,* %® GEL.
2 $&*+&$$&%&,#)-)*),)+ &%*)'&)+.)%+) &)
chamber inflammation (5%), eye pain (2%) and foreign body sensation (2%).
Please see brief summary of Prescribing Information on adjacent page.
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2015 Bausch & Lomb Incorporated. All rights reserved. Printed in USA. US/LGX/15/0041
12
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
CAPSULE SUPPORT
( Continued from page 10 )
Some ways to avoid suture erosion with
scleral-fixated IOLs include burying the knot
in the scleral groove, rotating the knots, leav-
IOLs
ing the suture ends long, attempting multiple
zig-zag scleral passes, covering the knot under
the scleral flap, performing intrascleral haptic
capture, or using a scleral pocket.
Another approach that surgeons could use
is sutured iris fixation of PC IOLs. Some contraindications for this approach include large
iris defects, iridoschisis, iris atrophy, aniridia,
USE IN SPECIFIC POPULATIONS
Pregnancy
Teratogenic Effects: Pregnancy Category C.
Loteprednol etabonate has been shown to be embryotoxic (delayed
ossification) and teratogenic (increased incidence of meningocele, abnormal
left common carotid artery, and limb flexures) when administered orally
to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the
maximum daily clinical dose), a dose which caused no maternal toxicity.
The no-observed-effect-level (NOEL) for these effects was 0.5 mg/kg/day
(6 times the maximum daily clinical dose). Oral treatment of rats during
Brief Summary: Based on full prescribing information.
organogenesis resulted in teratogenicity (absent innominate artery at ≥5 mg/
kg/day doses, and cleft palate and umbilical hernia at ≥50 mg/kg/day) and
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb at
embryotoxicity (increased post-implantation losses at 100 mg/kg/day and
1-800-323-0000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
decreased fetal body weight and skeletal ossification with ≥50 mg/kg/day).
Treatment of rats with 0.5 mg/kg/day (6 times the maximum clinical dose)
INDICATIONS AND USAGE
during organogenesis did not result in any reproductive toxicity. Loteprednol
LOTEMAX is a corticosteroid indicated for the treatment of post-operative
etabonate was maternally toxic (significantly reduced body weight gain during
inflammation and pain following ocular surgery.
treatment) when administered to pregnant rats during organogenesis at doses
DOSAGE AND ADMINISTRATION
of ≥5 mg/kg/day.
Invert closed bottle and shake once to fill tip before instilling drops.
Oral exposure of female rats to 50 mg/kg/day of loteprednol etabonate from
Apply one to two drops of LOTEMAX into the conjunctival sac of the affected
the start of the fetal period through the end of lactation, a maternally toxic
eye four times daily beginning the day after surgery and continuing
treatment regimen (significantly decreased body weight gain), gave rise to
throughout the first 2 weeks of the post-operative period.
decreased growth and survival, and retarded development in the offspring
CONTRAINDICATIONS
during lactation; the NOEL for these effects was 5 mg/kg/day. Loteprednol
etabonate had no effect on the duration of gestation or parturition when
LOTEMAX, as with other ophthalmic corticosteroids, is contraindicated in
most viral diseases of the cornea and conjunctiva including epithelial herpes administered orally to pregnant rats at doses up to 50 mg/kg/day during the
fetal period.
simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in
mycobacterial infection of the eye and fungal diseases of ocular structures.
There are no adequate and well controlled studies in pregnant women.
LOTEMAX should be used during pregnancy only if the potential benefit
WARNINGS AND PRECAUTIONS
justifies the potential risk to the fetus.
Intraocular Pressure (IOP) Increase
Prolonged use of corticosteroids may result in glaucoma with damage to the Nursing Mothers
It is not known whether topical ophthalmic administration of corticosteroids
optic nerve, defects in visual acuity and fields of vision. Steroids should be
used with caution in the presence of glaucoma. If this product is used for 10 could result in sufficient systemic absorption to produce detectable quantities
in human milk. Systemic steroids appear in human milk and could suppress
days or longer, intraocular pressure should be monitored.
growth, interfere with endogenous corticosteroid production, or cause other
Cataracts
untoward effects. Caution should be exercised when LOTEMAX is administered
Use of corticosteroids may result in posterior subcapsular cataract formation.
to a nursing woman.
Delayed Healing
Pediatric Use
The use of steroids after cataract surgery may delay healing and increase the
Safety and effectiveness in pediatric patients have not been established.
incidence of bleb formation. In those diseases causing thinning of the cornea
Geriatric Use
or sclera, perforations have been known to occur with the use of topical
No overall differences in safety and effectiveness have been observed
steroids. The initial prescription and renewal of the medication order should
between elderly and younger patients.
be made by a physician only after examination of the patient with the aid
of magnification such as slit lamp biomicroscopy and, where appropriate,
NONCLINICAL TOXICOLOGY
fluorescein staining.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Bacterial Infections
Long-term animal studies have not been conducted to evaluate the
Prolonged use of corticosteroids may suppress the host response and
carcinogenic potential of loteprednol etabonate. Loteprednol etabonate was
thus increase the hazard of secondary ocular infections. In acute purulent
not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in
conditions of the eye, steroids may mask infection or enhance existing
a chromosome aberration test in human lymphocytes, or in vivo in the single
infection.
dose mouse micronucleus assay. Treatment of male and female rats with up to
50 mg/kg/day and 25 mg/kg/day of loteprednol etabonate, respectively, (600
Viral Infections
Employment of a corticosteroid medication in the treatment of patients with and 300 times the maximum clinical dose, respectively) prior to and during
a history of herpes simplex requires great caution. Use of ocular steroids may mating did not impair fertility in either gender.
prolong the course and may exacerbate the severity of many viral infections PATIENT COUNSELING INFORMATION
of the eye (including herpes simplex).
Administration
Fungal Infections
Invert closed bottle and shake once to fill tip before instilling drops.
Fungal infections of the cornea are particularly prone to develop coincidentally Risk of Contamination
with long-term local steroid application. Fungus invasion must be considered Patients should be advised not to allow the dropper tip to touch any surface,
in any persistent corneal ulceration where a steroid has been used or is in
as this may contaminate the gel.
use. Fungal cultures should be taken when appropriate.
Contact Lens Wear
Contact Lens Wear
Patients should be advised not to wear contact lenses when using LOTEMAX.
Patients should not wear contact lenses during their course of therapy with
Risk of Secondary Infection
LOTEMAX.
If pain develops, redness, itching or inflammation becomes aggravated, the
ADVERSE REACTIONS
patient should be advised to consult a physician.
Adverse reactions associated with ophthalmic steroids include elevated
FOR MORE DETAILED INFORMATION, PLEASE READ THE PRESCRIBING
intraocular pressure, which may be associated with infrequent optic nerve
INFORMATION.
damage, visual acuity and field defects, posterior subcapsular cataract
Bausch & Lomb Incorporated
formation, delayed wound healing and secondary ocular infection from
pathogens including herpes simplex, and perforation of the globe where there Tampa, Florida 33637 USA
US Patent No. 5,800,807
is thinning of the cornea or sclera.
©Bausch & Lomb Incorporated
The most common adverse drug reactions reported were anterior chamber
®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
inflammation (5%), eye pain (2%), and foreign body sensation (2%).
9303400
and a younger person who is particularly active, as too much activity could lead to suture
tearing or suture slippage, Dr. Hoffman said.
Intrascleral haptic capture is another possible approach for lack of capsule support. Some
complications intraoperatively include hyphema,
haptic breakage, and a deformed haptic. Early
complications include corneal edema, epithelial defects, and iritis, and late complications
can include optic capture, IOL decentration,
haptic extrusion, and possible re-treatment.
Intrascleral haptic capture does have a learning curve, Dr. Hoffman explained. However,
surgeons who have become familiar with the
technique believe that it is easier to perform
intrascleral haptic capture than suturing IOLs
to the sclera.
SURGEON’S A DV ICE
As surgeons decide which approach is best for
them, Dr. Hoffman had some advice.
“When approaching cases with no capsular support, surgeons should perform the procedure they are most comfortable with,” Dr.
Hoffman said.
“However, surgeons should become familiar with the various available techniques as
there may be instances where one procedure
is better than another for a particular patient,”
he added.
He also cited a study that reviewed the literature from 1980 to 2002 regarding IOL implantation in the absence of capsular support.
The study supported the use of open-loop AC,
scleral-sutured PC IOLs, and iris-sutured PC
IOLS.
That study did not find sufficient evidence to
suggest the superiority of one technique over
another, Dr. Hoffman concluded.4 ■
References
1. Lyle AW, Jin JC. Secondary IOL implantation: AC
versus PC IOL. Ophthalmic Surg. 1993;24:375-381.
2. Donaldson KE, Gorscak JL, Budenz DL. AC and
sutured PC IOLs in eyes with poor capsular support.
J Cataract Refractive Surg. 2005;903-909.
3. Kwong YY, Yuen HK, Lam RF, et al. Comparison of
outcome of primary scleral-fixated versus primary ac
IOL implantation in complicated cataract surgeries.
Ophthalmology. 2007;114:80-85.
4. Wagoner MD, Cox TA, Ariyasu RG, et al. IOL
implantation in the absence of capsular support: A
report by the AAO. Ophthalmology. 2003;110:840-859.
RICHARD S. HOFFMAN, MD
E: [email protected]
This article was adapted from Dr. Hoffman’s presentation during the 2014 meeting
of the American Academy of Ophthalmology. Dr. Hoffman did not indicate any
proprietary interest in the subject matter.
13
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Warm viscoelastic eases IOL unfolding
Technique reduces flipping during rotation; works with other hydrophobic acrylic implants
By Cheryl Guttman Krader; Reviewed by Mitchell A. Jackson, MD
L AK E VIL L A, IL ::
USE OF WARM VISCOELASTIC is
UNFOLDING THE IOL
a safe and effective technique for facilitating
implantation of a certain hydrophobic acrylic
IOL (enVista model MX60, Bausch + Lomb),
said Mitchell A. Jackson, MD.
The warm viscoelastic enabled IOL delivery and hastened its unfolding. Inadvertent
flipping of the IOL during
rotation was reduced. The
warm viscoelastic was very
easy to remove at the end of
the procedure, said Dr. Jackson, founder and chief execuVIDEO The warming technique
tive officer, Jacksoneye, Lake
accelerates
unfolding of the hydrophobic acrylic
Dr. Jackson
Villa, IL.
IOL. Go to http://bit.ly/1eg8qPn
He conducted a retrospective review of his
(Video courtesy of Mitchell A. Jackson, MD)
experience with this approach in a series
of 175 eyes of 99 patients who underwent
phacoemulsification and implantation of the has advantages for increasing resistance to
single-piece, prehydrated hydrophobic acrylic damage from surgical instruments and mainlens in a femtosecond laser-assisted cataract taining long-term clarity,” he said.
However, the unique hydrophosurgery procedure.
bic acrylic of the lens is relatively
Mean surgical time (including
stiff, which causes it to open very
the femtosecond laser portion of
slowly and makes it susceptible
the procedure) was 12 minutes,
to being inadvertently flipped if
and his safety review identified
A warm viscoelastic
rotation is attempted before unno intraoperative complications, technique aids in the
folding is complete, he explained.
problems with IOP spikes after intraoperative delivery
“Warming increases flexibilsurgery, or evidence of increased and unfolding of a
ity
of hydrophobic acrylics, and I
endothelial damage.
hydrophobic acrylic IOL
Based on his positive experi- during cataract surgery. found that using warm viscoelastic in the IOL cartridge and to fill
ence, Dr. Jackson said he is now
using warm viscoelastic when implanting the capsular bag greatly facilitates intraocular
delivery of the [lens] and hastens its unfoldany hydrophobic acrylic IOL.
This particular IOL “has been associated ing,” Dr. Jackson said. “With the switch to
with excellent results, and its novel material warm viscoelastic, [this IOL] has gone from
being the slowest to
the fast unfolding
implant that I use.”
Other surgeons
have reported on the
benefits of using a
warming technique
to accelerate unfolding of this IOL or
other hydrophobic
acrylic implants, Dr.
Jackson noted.
— Mitchell A. Jackson, MD
In addition, different approaches
take-home
‘With the switch to warm
viscoelastic, [this IOL] has gone
from being the slowest to the
fast unfolding implant that I use.’
An ultrasonic gel warmer is used for the warming
technique. There are three temperature settings,
but the lid of the device is always kept open
to vent and prevent inadvertent overheating.
Average temperatures range from 95° to 104°F
(35° to 40°C). (Photo courtesy of Mitchell A. Jackson, MD)
have been described to raise the temperature of the material.
A PPLY I NG H E AT
Dr. Jackson’s technique involves placing the
viscoelastic syringes in their sterile packaging
into an ultrasonic gel warmer. The device he
uses has three temperature settings, and he
turns it to the highest level, which can raise
the temperature up to 104° F.
In order to prevent overheating of the viscoelastic, however, he keeps the lid of the device
open. The viscoelastic is kept in the warmer
until it is needed for the IOL implantation.
By the time the viscoelastic is placed in the
eye, the temperature typically is just above
normal body temperature range, Dr. Jackson
explained. ■
MITCHELL A. JACKSON, MD
E: [email protected]
This article was adapted from Dr. Jackson’s presentation during the 2015 meeting
of the American Society of Cataract and Refractive Surgery. Dr. Jackson is a consultant
to Bausch + Lomb.
14
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
TRIFOCAL
IOLs
FineVision MicroF trifocal
( Continued from page 1 )
take-home
ReSTOR SN6AD1 +3D bifocal
ADD per @ IOL plane
+3.00 D
Distance: 45%
Intermediate: 20%
Near: 35%
Energy distribution
(3 mm)
Distance: 59%
Near: 25.5%
–0.11 μm
Asphericity
–0.10 μm
(FIGURE 1) Characteristics of the FineVision trifocal and ReSTOR IQ +3.00 D bifocal multifocal IOL.
(Figures courtesy of Rudy M.M.A. Nuijts, MD, PhD)
(FIGURE 2) The AT LISA tri 839MP distributes 50% of
light for far, 20% for intermediate, and 30% for near.
At the IOL plane it provides a near add of +3.33 D and
an intermediate add of +1.66 D. (Image courtesy of Carl Zeiss
Trifocal optic
over 4.34 mm
Meditec)
Bifocal from
4.34 to 6.0 mm
Defocus addition (D)
–0.20
0.00
Visual acuity (LogMAR)
The study conducted by Dr. Nuijts and colleagues is in press in the Journal of Cataract
and Refractive Surgery and is
scheduled for publication in
August 2015.1 It enrolled 28
patients randomly assigned
to bilateral implantation with
a trifocal diffractive MFIOL
(FineVision MicroF, PhysIOL)
Dr. Nuijts
or a bifocal diffractive MFIOL
(AcrySof ReSTOR IQ +3, model SN6AD1; Alcon
Laboratories).
The trifocal IOL distributes 45% of incoming light to distance, 20% to intermediate, and
35% to near (versus 59% to distance and 25.5%
to near with the bifocal MFIOL) and features
two superimposed bifocal patterns—one with
a +1.75 D add and one with a +3.5 D add.
The trifocal and bifocal MFIOLs evaluated in
the study have similar negative asphericity of
–0.11 and –0.10 μm, respectively (Figure 1).
No significant differences were found between the two groups of eyes in mean age or
preoperative distance best-corrected visual acuity (BCVA). The refractive outcome at 6 months
was also similar in the bifocal and trifocal
groups (mean SE 0.11 and 0.03 D, respectively).
In binocular defocus curve testing, the trifocal group performed 0.16 logMAR better for
defocus level –1 D (p
< 0.01, equivalent of
100 cm reading distance) and both groups
achieved 0.2 logMAR or
Multifocal IOLs with
better in the range from a trifocal diffractive
0 to –3 D. There was no optic design are
significant difference available outside of
between the two IOL the United States. They
groups in mean mon- provide good visual
ocular uncorrected or acuity for distance,
distance corrected vi- intermediate, and
sual acuity at far, inter- near and appear to
mediate, or near.
provide slightly better
However, the rate of intermediate vision
complete spectacle in- than bifocal diffractive
dependence was higher multifocal IOLs.
in patients with the
trifocal MFIOL implanted than in the bifocal
MFIOL group (80% versus 50%).
Results from contrast sensitivity testing under
photopic and mesopic conditions showed the
only significant difference between groups was
at 6 cycles per degree under mesopic conditions. Data from the National Eye Institute Refractive Error Quality of Life Instrument-42
Parameter
+1.75
+3.50
0.20
0.40
0.60
0.80
1.00
1.20
3
2
1
0
FineVision Toric
–1
–2
–3
–4
POD FineVision
(FIGURE 3) Defocus curve of FineVision POD versus FineVision Toric. (Figure courtesy of Rudy M.M.A. Nuijts, MD, PhD))
found no differences between the two implant
groups in the quality of vision or perceived
glare and halos.
DATA FROM OTHER STUDIES
Dr. Nuijts also reviewed data from three other
published studies investigating the same trifocal MFIOL in larger groups of eyes (n = 40 to
198),2-4 a cohort study including 60 eyes implanted with another aspheric trifocal MFIOL
(AT LISA tri 839MP, Carl Zeiss Meditec), 5 and
a randomized trial comparing the latter IOL
with a bifocal diffractive MFIOL from the
same manufacturer (AT LISA 801, Carl Zeiss
Meditec).6
The AT LISA tri 839MP distributes 50% of
light for far, 20% for intermediate, and 30%
for near. At the IOL plane it provides a near
add of +3.33 D and an intermediate add of
+1.66 D (Figure 2).
Dr. Nuijts reported that distance BCVA outcomes were similar for the two trifocal/one
bifocal MFIOLs across all studies. Distancecorrected intermediate visual acuity for the
trifocal MFIOLs ranged from 0.06 to 0.17 logMAR and was significantly better with the
trifocal MFIOL than the bifocal MFIOL in the
direct comparison study (0.06 versus 0.30).
Dr. Nuijts also discussed in vitro research
comparing the two trifocal MFIOLs, including
Special Report )
TECHNOLOGICAL ADVANCES IN
a laboratory bench-based study
evaluating through-focus modulation transfer function curves.7
Quality of vision was simulated
using different sized apertures (2,
3, 3.75, and 4.50 mm) and changing
diopters of defocus representing
distance (0.0 D = 4 m), intermediate (–1.5 D = 67 cm), and near
vision (–3/–3.5 D = 33/29 cm).
Results showed the FineVision
MicroF trifocal IOL would provide
better vision at distance in eyes
with larger pupils (3.75 mm) compared with the AT LISA tri 839MP.
However, the AT LISA tri 839MP
had better results at intermediate
and near focal points and was less
dependent on pupil size.
A clinical trial comparing the
FineVision MicroF and AT LISA
tri 839MP IOLs in 30 patients who
underwent bilateral implantation
with the same lens found both
trifocal MFIOLS were associated
with excellent distance, intermediate, and near visual outcomes
at 3 months. 8
Statistically significant differences favoring the FineVision IOL
were seen in analyses of distancecorrected intermediate and near
visual acuity.
“Regrettably, because pupil diameter was not measured, it was
not possible to assess the influence
of pupil size on the in vivo results
of this study,” Dr. Nuijts said.
T O R I C , N O N -T O R I C
MODELS
A toric version of the FineVision
trifocal MFIOL is also available
in cylinder powers ranging from
1 to 6 D in 0.75-D steps, he noted.
A small unpublished study,
which has been presented by Roberto Bellucci, MD, compared visual outcomes after bilateral implantation with the non-toric and
toric versions of the FineVision
trifocal MFIOL. It found no differences in uncorrected or distancecorrected visual acuity at near,
intermediate, or distance.
In the defocus curve, mean visual acuity was 0.2 logMAR or
better from 1 to –3 D of defocus
for both IOL types (Figure 3 on
Page 14). ■
IOLs
References
1. Jonker SM, Bauer NJ, Makhotkina
NY, Berendschot TT, van den
Biggelaar FJ, Nuijts RM. Comparison
of FineVision Micro F trifocal IOL
with ReSTOR IQ +3.0 D bifocal IOL:
Results of a prospective randomized
clinical trial. J Cataract Refract Surg.
In press.
2. Alió JL, Montalbán R, Peña-García
P, Soria FA, Vega-Estrada A. Visual
outcomes of a trifocal aspheric
diffractive intraocular lens with
microincision cataract surgery. J
Refract Surg. 2013;29:756-761.
3. Cochener B, Vryghem J, Rozot P, et
al. Visual and refractive outcomes
after implantation of a fully diffractive
trifocal lens. Clin Ophthalmol.
2012;6:1421-1427.
4. Cochener B, Vryghem J, Rozot P, et
al. Clinical outcomes with a trifocal
intraocular lens: a multicenter study.
J Refract Surg. 2014;30:762-768.
5. Mojzis P, Peña-García P, Liehneova
I, Ziak P, Alió JL. Outcomes of a new
diffractive trifocal intraocular lens. J
Cataract Refract Surg. 2014;40:6069.
6. Mojzis P, Kukuckova L, Majerova K,
Liehneova K, Piñero DP. Comparative
analysis of the visual performance
after cataract surgery with
implantation of a bifocal or trifocal
diffractive IOL. J Refract Surg.
2014;30:666-672.
7. Ruiz-Alcocer J, Madrid-Costa D,
García-Lázaro S, Ferrer-Blasco T,
Montés-Micó R. Optical performance
of two new trifocal intraocular lenses:
through-focus modulation transfer
function and influence of pupil
size. Clin Experiment Ophthalmol.
2014;42:271-276.
8. Marques EF, Ferreira TB. Comparison
of visual outcomes of 2 diffractive
trifocal intraocular lenses. J Cataract
Refract Surg. 2015;41:354-363.
RUDY M.M.A. NUIJTS, MD, PHD
E: [email protected]
This article was adapted from Dr. Nuijts’ presentation at the
2015 meeting of the American Society of Cataract and Refractive Surgery. His collaborators included Soraya M.R. Jonker,
MD; Noël J.C. Bauer, MD, PhD, and Roberto Bellucci, MD.
Dr. Nuijts receives grant support from PhysIOL and Alcon
Laboratories and is also a consultant and speaker for Alcon
Laboratories.
SORAYA M.R. JONKER, MD
E: [email protected]
Dr. Jonker did not indicate any financial interest in the subject
matter.
Invaluable
15
JUNE 1, 2015 :: Ophthalmology Times
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
16
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Preloaded IOL delivery system results
in time savings per case, surgeon
Single-use approach also beneficial for reduced risk of infection and sterilization errors
By Nancy Groves; Reviewed by Guillermo Rocha, MD, FRCSC
The observers concluded that an average of
1.2 more cases per day could be performed at
total case time and surgeon lens time for a the Canadian site, which was a public hospinew preloaded IOL delivery system (Tecnis tal, according to Dr. Rocha.
To put this difference in perspective, Dr.
iTec, Abbott Medical Optics) were confirmed
Rocha explained that if he performed catain a recent multisite time and motion study.
ract surgery at this hospital once a
The study compared a manuweek, that would equate to 4 more
ally loaded delivery system with
cases a month or about 48 extra
the preloaded device, which was
cases a year without stretching the
designed to improve efficiency in
hospital’s resources or hiring adthe operating room.
Use of a new
ditional staff.
Third-party observers collected
preloaded IOL delivery
“It may not sound like much,
intraoperative time and motion data
system for routine
but when we’re dealing with waitfor all surgical staff before and after
cataract surgeries in
ing lists (for surgery), any little bit
adoption of the system at three cena multicenter study
that we can do is definitely signifiters: a single-operating room set-up
resulted in time savings
cant,” Dr. Rocha said.
in Manitoba, Canada, where about
per case and per
He also noted that performing
10 or 11 cataract procedures were
surgeon that could
the additional cases would result
performed per day; a two-operating
reduce costs per case
in little if any additional cost to the
room set-up in France, capable of
or increased profit.
hospital system, since the operathandling about 18 cases per day;
ing room staff would already be on
and a two-room site in Iowa where
duty and paid for their time, and
about 25 procedures could be perone additional case per day would
formed per day.
A minimum of 20 cataract surgeries with not put undue pressure on the team.
manually loaded IOLs were performed, followed
by training for the physicians and surgical staff
IMPROV ED EFFICIENCIE S
on use of the system, then an additional series The data analysis from the three sites showed
of surgeries using the preloaded device. About that capital and labor cost efficiencies resulting
154 surgeries were performed in all.
from additional throughput reduced the mean
Guillermo Rocha, MD, FRCSC, GRMC Vision cost per case by an estimated 2.4% in France
Centre, Brandon, Manitoba, Canada, performed and 4.2% in Canada. The revenue implications
all the surgeries at the Manitoba site; Jason J. of additional throughput in the United States
Jones, MD, was the surgeon at the U.S. site, were estimated to increase profit by 5.3%. Time
and Serge Zaluski, MD, performed the proce- savings due to improved throughput were a
dures in France.
gain of 4% in the United States, 5.7% in France,
and 9.9% in Canada.
TOTAL CASE TIME,
Dr. Rocha described the preloaded system
as standard and almost “foolproof”—one that
SURGEON LENS TIME
The reduction in total case time was 12% in could be completed in three steps: injection
Canada (p < 0.001), 9.4% in the United States of viscoelastic and cap removal, pushing the
(p < 0.001), and 6.2% in France (p < 0.05). plunger to the dwell position, and depressing
The reductions in surgeon lens time were 43.7% the plunger to insert the lens.
No time is wasted because the lens is loaded
in Canada, 31.9% in France, and 17.4% in the
United States (all sites, p < 0.001). The mean while the ophthalmologist is completing the
difference was 0.8 minutes per case in Can- surgery, he explained.
A second benefit, which also helps improve
ada and 0.4 minutes at the sites in the United
efficiency, is that the device is a single-use
States and France.
BR ANDON, MANI TOBA, CANADA ::
SIGNIFICANT REDUCTIONS in
take-home
The design of the no-touch, single-use
preloaded IOL delivery system (Tecnis iTec,
Abbott Medical Optics) for use during
routine cataract surgery streamlines time
associated with IOL delivery, preparation, and
management, while also assuring sterility.
(Photo courtesy of Abbott Medical Optics)
system. The nurses do not have to remove the
cartridge, clean the inserter, and send it to another department for sterilization, as with a
reusable device. This also reduces the risk of
infection or sterilization errors.
In addition, surgeons do not have to touch
the lens, which could cause damage or contamination. Since the lens is encased in a disposable cartridge and inserter, there is minimal contact with the exterior as well.
“It’s a cleaner way of delivering the lens without it being exposed to any potential contaminants,” said Dr. Rocha, adding that the amount
of contact with the lens was not an aspect of
the study but rather his personal observation.
“For me, the most important thing was having a consistent and predictable way of delivering the lens, not wasting time preparing
the lens and loading it but having it ready,”
Dr. Rocha said. “Just as soon as I’m done, the
nurse passes it to me and I inject it. That really has made my operating room days more
efficient.” ■
GUILLERMO ROCHA, MD, FRCSC
E: [email protected]
Dr. Rocha serves on the advisory board for Abbott Medical Optics (AMO) and is also
a consultant and has received speaker honoraria. However, he did not receive any
funding from AMO for this project, which was required as part of his relationship with
the hospital where the study took place.
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Paul Austin Chander Distinguished
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Axonal Transport and Cytoid Bodies:
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18
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Modified posterior chamber phakic IOL
facilitates surgery, improves outcomes
Implantable collamer lens yields predictability, safety, stability from follow-up to 1 year
By Cheryl Guttman Krader; Reviewed by Erik L. Mertens, MD
AN T WERP, BELGIUM ::
DESIGN MODIFICATIONS have
made refractive surgery with a certain posterior chamber phakic IOL easier and safer than
before and enabled its use in a broader patient
population, according to Erik L. Mertens, MD.
Previously, the implantable collamer lens
(Visian ICL V4C CentraFLOW, STAAR Surgical) was considered by Dr. Mertens only for
eyes that were not good candidates for LASIK
because they had a thin cornea, dry eye, forme
fruste keratoconus, high myopia, or hyperopia, he said.
“Now, almost every patient seeking correction of myopia and myopic astigmatism is suitable for the [lens],” said Dr. Mertens, medical
director, Eye Center Medipolis, Antwerp, Belgium. “In 2005, the [lens] accounted for only
14% of my refractive surgeries, whereas in
2014, almost 97% of patients seeking refractive surgery were implanted with the [device].”
The lens features a 360-μm hole in the center of the optic (Aquaport) that enables more
natural aqueous flow between the device and
the crystalline lens while also eliminating the
need for iridotomies in recipients of this phakic IOL.
There are also two similarly sized holes outside the optic—one on either side—that facilitate intraoperative removal of viscoelastic and
allow aqueous to flow over a wider surface
area of the crystalline lens.
“The addition of the penetrating holes elimi-
nates the need for an extra procedure preop- at postoperative follow-up visits conducted at
eratively and the potential complications that 1, 3, 6 and 12 months, SE was plano in 96% to
99% of eyes. Mean SE was 0.02 D
can occur with iridotomy/iridecat 1 month and was stable at 0.01
tomy,” Dr. Mertens said. “By creD at all subsequent follow-up visits.
ating more natural aqueous flow,
Uncorrected visual acuity (UCVA)
they also reduce the risk of lens
and best-corrected visual acuity
opacification.
The implantable
(BCVA) at 1 year were better than
“During follow-up that ranges
collamer lens features
preoperative BCVA. UCVA was 20/20
up to 3 years in a series of 569
several design
or better in 97.3% of eyes and 98.6%
eyes with the [device] implanted,
enhancements that
had BCVA of 20/20 or better.
I have seen no cases of lens opacimake the procedure
Safety was excellent as well.
fication,” he added.
more patient- and
No eyes lost BCVA and about 40%
Other design modifications insurgeon-friendly.
gained 1 or more lines. There were
clude extension of the axis alignno cases with pupillary block or
ment markings on the toric version, which makes accurate orientation easier increased IOP.
Data from optical coherence tomography
and enables postoperative assessment of the
measurements of vault at the center of the
phakic IOL’s position, he noted.
In addition, the lens is stored in balanced ICL showed that the clearance distance desalt solution rather than saline, so that it is creased during the first year and then stabilized. Mean vault at 1 year was about 410 μm,
fully hydrated.
but the vault was <100 μm in 23 eyes.
As the device design provides a more natural
R EFR ACTI V E OU TCOMES
Results from follow-up to 1 year for 306 eyes flow of aqueous, the lens can tolerate a much
with the lens implanted for myopia or myopic lower vault, Dr. Mertens said. ■
astigmatism show it provides predictable, safe,
effective, and stable refractive correction. The
patients, all operated on by Dr. Mertens, had
a mean age of about 32 years, mean sphere of
ERIK L. MERTENS, MD
about –6 D (range –0.75 to –14.75 D), and mean
E: [email protected]
cylinder of about –1 D (range 0 to –4.25 D).
This article was adapted from Dr. Mertens’ presentation at the 2014 meeting of the
Achieved spherical equivalent (SE) almost
American Academy of Ophthalmology. Dr. Mertens is a consultant to Bausch + Lomb,
perfectly matched the attempted correction, and
Ophtec, PhysIOL, STAAR Surgical, and TechnolasPV.
take-home
AAO issues statement regarding study linking Ebola and uveitis
THE AMERICAN Academy of Ophthalmology (AAO) has issued a statement following a report in the New England Journal of
Medicine about an Ebola patient with uveitis.
“The medical community has appreciated
that the Ebola virus can remain viable in some
body fluids for an extended period of time after
the initial onset of the disease,” said Russell
N. Van Gelder, MD, PhD, president of the AAO
and a uveitis specialist. “This remarkable case
now demonstrates that the virus can remain
viable in ocular fluids long after the patient has
recovered from the systemic infection.
“If the Ebola epidemic continues, ophthal-
mologists throughout the world will be seeing
patients with post-Ebola uveitis, will need to
recognize and treat this condition, and will
need to take appropriate increased precautions
in performing surgical procedures on these
patients,” Dr. Van Gelder explained.
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JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Approaches to toric IOL alignment
reflected in clinical trends, practice
Surgical technique also plays a role in the stability and performance of lenses
By John A. Vukich, MD, Special to Ophthalmology Times
UCVA 6 Months Post-Implantation
48%
50%
40%
31%
30%
20%
10%
6%
5%
5%
5%
Other
Intraoperative
aberrometry
Digital image
registration
Preoperative ink marking
+ intraoperative ink
marking with axial tools
Preoperative ink
markingw ithout
the aid of axial tools
Anatomical landmarks/
no marking
0%
First Operative Eyes (%)
Method for Alignment of Toric IOLs
100
97%
89.1%
80
Tecnis Toric ZCT150
IOL (n = 101)
Control (n = 93)
87.1%
74.2%
71.3%
54.8%
60
43.6%
40
23.7%
12.9%
20
3%
0%
20/50
to 20/80
20/100
or worse
0
20/20
or better
20/25
or better
20/32
or better
20/40
or better
0%
Cumulative UCDVA
(FIGURE 1) In the 2014 Clinical Trends Survey, American Society of Cataract
and Refractive Surgery members and meeting attendees identified a range of
strategies for marking the axis in toric IOL cases.
(FIGURE 2) Six months post-implantation, 97% of eyes with a toric IOL (Tecnis Toric,
Abbott Medical Optics) had uncorrected distance acuity of 20/40 or better.
(Figures courtesy of John A. Vukich, MD)
effectiveness of incisional correction, especially if patients are interested in spectacle
matism in patients with cataracts with ≥1.25 independence at near.
Good candidates for a toric IOL include paD of astigmatism, implanting a toric IOL is the
tients who desire good uncorrected distance
most common approach.
vision and are comfortable with
Consider that toric IOLs were imwearing spectacles for near. Topogplanted in 19% of cataract surgery
raphy is essential to determining
procedures,1 according to the 2014
that astigmatism is regular and
American Society of Cataract and
stable and there is no significant
Refractive Surgery Clinical Trends
Though it is generally
corneal disease affecting the ocuSurvey—to which more than 1,500 agreed that accurate
lar surface or shape.
surgeons responded.
identification of the
It is important to ensure that
In addition, with several new magnitude and axis
the best astigmatic correction of
toric IOLs in the marketplace, this of astigmatism is
an irregular cornea—i.e., one with
category has been growing rap- essential in order to
pellucid marginal degeneration,
idly and has much room for ex- choose the right toric
keratoconus, or forme fruste kerapansion—given that about 37% power and correctly
toconus—is not substituted for the
of the population has >1 D of position it, there is no
true axis of astigmatism.
astigmatism.
strong consensus about
Among good candidates, there
In this surgeon’s hands, toric which measurement is
is potential for error in selecting
lenses are more predictable and best to base magnitude
the axis or magnitude of astigmamore consistent at achieving the and axis decisions.
tism and in correctly aligning the
desired results than incisional Results from a recent
IOL in the eye. For every degree
correction at 1 D or greater of clinical survey support
the lens is rotated off-axis, there
astigmatism. At lower levels (1 this trend.
is a 3.3% loss of effectiveness of
to 1.5 D), it is a reasonable decision to sacrifice some of the predictability the toric IOL power.2
of a toric IOL for the convenience and costFor best results, the IOL should be within
MADISON, WI ::
WHEN IT COMES TO addressing astig-
take-home
5˚ of the intended axis, especially when implanting higher-power toric lenses. Despite
this, survey respondents indicated that an
average 7.2˚ of rotational error would be acceptable, with about one-third of respondents
being comfortable with rotational error of 10˚
or more.1
DETER MINE M AGNIT UDE , A X IS
Accurate identification of the magnitude and axis
of astigmatism is essential in order to choose
the right toric power and correctly position it.
However, there is no strong consensus about
which measurement is the best one on which
to base magnitude and axis decisions.
In the survey, IOLMaster Ks were most commonly used to determine magnitude, followed
by topography and manual Ks. Topography is
most heavily relied upon for axis determination, with IOLMaster and Lenstar following.
Other methods—including autokeratometry
and intraoperative aberrometry—are also used.
Though these are all good methods, ideally,
one should have at least two different measures
from two different devices. Because each device measures slightly differently, the Ks are
unlikely to be identical, but close agreement
should be sought and significant differences
21
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
among measurements should be reconciled to
avoid power calculation or axis errors.
In selecting the best lens power, it is perfectly acceptable to flip the axis, even though
nearly one-half of surgeons say they never do
this.1 The conventional wisdom not to flip the
axis is based on incisional techniques, when an
axis shift could not be reasonably controlled
and might result in a large and poorly tolerated error in the opposite axis.
However, with an optical lens solution that
does not involve relaxing the cornea, surgeons
have more control. If the choice were between
leaving 0.50 D of residual error at the original
axis or 0.10 D at the opposite axis, it would
be preferable to flip the axis. The amount of
residual error is so small that it will be easily tolerated.
MARKING THE AXIS
Survey results demonstrate there is also considerable variation in how surgeons mark and
align toric IOLs.1
Thirty-seven percent say they rely on anatomical landmarks without marking the cornea or only mark the major axes preoperatively
without using any additional axial marking
tools during surgery (Figure 1 on Page 20).
For accurate placement, the latter is required,
at a minimum.
Ideally, the principal meridians should be
marked preoperatively with the patient in a
seated position, and the axis marked intraoperatively with the aid of an axial tool. A fine,
durable mark that does not wear off or subtend more than a few degrees should be made.
The initial meridian marks can be used as
a point of reference intraoperatively, with the
patient lying down, to accurately mark the
axis of astigmatism even if some cyclorotation
has occurred. A Mendez ring or other axial
ink marker (one that leaves a fine, durable
mark) will be more accurate than surgeons’
estimation of the axis in relation to the principal meridians.
Other marking techniques have been developed and shown to be quite accurate. For
example, Robert Osher, MD, has described a
thermal device that leaves a fine mark. Others have used a Nd:YAG laser to pit the epithelium at the limbus or a sterile needle to
create a linear superficial abrasion that can
be stained with fluorescein or another dye to
highlight the mark.
Advanced devices—such as intraoperative
aberrometry or surgical guidance systems that
incorporate digital registration—are not necessary for implantation of toric IOLs, but they do
add greater precision for surgeons who want
to maximize outcomes.
IOLs
TECHNOLOGICAL ADVANCES IN
bility. In clinical studies, the mean change in
axis between baseline and 6 months was just
2.74°, indicating good lens stability within the
capsular bag.3
Ninety-three percent of eyes with this lens
implanted had a change in axis of ≤5° between
two consecutive visits about 3 months apart,
Continues on page 27 : Alignment
ALIGNING THE LENS
For implantation of the IOL, it is important to
choose a rotationally stable toric lens. Unless
a very high-powered toric lens is needed, this
surgeon’s personal preference is a certain toric
IOL (Tecnis Toric, Abbott Medical Optics). The
platform offers predictable, high-quality performance in general, including excellent sta-
Instrumentation
Double-X Speculums
patent
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gton,
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hu, M
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This speculum combines arms that open in a
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for the reduction of external pressure on the
globe. This significantly aids in docking the
laser to the eye.
K1-5696 (17mm blades)
K1-5697 (13mm blades)
Incision Spatulas
, NY
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kvill
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pointed
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blunted
K3-2440
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Two versions of this 0.3mm wide incision opening
spatula are available. One has a pointed tip
(K3-2440) for surgeons who occasionally find
incisions challenging to find and open, while
the other (K3-2442) has a blunt tip for entering
these incisions.
This double ended instrument features the
blunted 0.3mm incision spatula on one end and
a 2mm wide blunt, keratome-shape spatula for
opening the main incision on the other.
Nucleus Splitters
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The ultra thin tips on these splitters are designed
to fit into the laser created grooves in the nucleus
to safely fragment down to the posterior plate. One
instrument can be used in conjunction with the phaco
tip or two through opposing incisions in a bimanual
technique.
K3-2448 for use in the right hand
K3-2449 for use in the left hand
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22
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Low-add IOLs provide personalized
best range for near, intermediate
Patients achieved comparable distance vision relative to monofocal IOL at 6 months
By Cheryl Guttman Krader; Reviewed by Daniel H. Chang, MD
BAK ERSF IEL D, CA ::
NEW LOW-ADD VERSIONS of the
1-piece multifocal IOL (Tecnis Multifocal, Abbott Medical Optics) afford cataract surgeons
an opportunity to customize selection of the
presbyopia-correcting IOL according to a patient’s vision needs. In addition, they appear
to have the potential to minimize halos, which
are intrinsic to multifocal optics, said Daniel
H. Chang, MD.
Dr. Chang presented results from the FDA
study investigating the +2.75 D and +3.25 D
add versions of the hydrophobic acrylic, aspheric diffractive
multifocal IOL (models ZKB00
and ZLB00, respectively).
The theoretical reading distances for the +2.75 D, +3.25
D, and original +4.0 D add
Dr. Chang
models (ZMB00) are 50, 42,
and 33 cm (20, 17, and 13 inches), respectively.
The low-add IOLs are based on the same spherical aberration-correcting design and chromatic
aberration-minimizing material as the +4.0
D add model.
A full diffractive surface provides quality vision and pupil independence with equal light
distribution between distance and near, explained Dr. Chang, who was an investigator
in the FDA study and is in private practice,
Empire Eye and Laser Center, Bakersfield, CA.
LEFT A slit lamp photograph shows the ZKBOO lens
model. RIGHT A pupil image (Atlas topographer)
shows the ZLBOO lens model. (Photos courtesy of Daniel
H. Chang, MD)
However, the low-add multifocal IOL groups
benefited with a >3-line improvement in near
visual acuity, increased spectacle dependence,
and a higher level of satisfaction with their
uncorrected vision.
All three versions of the multifocal IOL “are
great options as each can provide comfortable
uncorrected vision at distance, intermediate,
and near in more than 80% of patients,” Dr.
Chang said. “However, with the two new lowadd versions, I can now provide patients with
a personalized best range for near and intermediate vision.”
He added that relative to the original +4.0 D
add Tecnis multifocal IOL, the lowA BOU T T H E ST U DY
add versions seem to be associated
The FDA study was a prospective,
with fewer night-vision complaints
multicenter, bilateral, open-label,
and halos in particular.
evaluator-masked, modified paralThe FDA study did not directly
lel group clinical trial. It enrolled
Low-add multifocal
compare the low-add IOLs with
445 patients who received either IOL models improved
the +4.0 D version.
the +2.75 D add multifocal IOL, near vision and
However, the frequency of vithe +3.25 add multifocal IOL, or increased spectacle
sual symptoms seem to decrease
the 1-piece aspheric monofocal ver- independence while
as the add power decreases, and
sion (Tecnis IOL, ZCB00).
providing comparable
that is particularly true for halos,
Results from testing performed distance vision to the
according to Dr. Chang.
at 6 months after the second eye monofocal control.
“Therefore, the availability of
surgery showed patients in the lowadd multifocal IOL groups achieved compara- the low-add versions of the . . . multifocal
ble distance vision relative to the controls that IOL allow me to have some control over these
night-vision symptoms,” he said.
received the monofocal IOL.
take-home
ST U DY DE SIGN, T E ST I NG
Patients enrolled in the FDA study chose the
lens type to have implanted based on consideration of their needs for near and intermediate vision and assessment of their preferred
reading distance.
At 6 months, over 99% of patients enrolled
in the study were available for evaluation. In
binocular testing, mean logMAR distance uncorrected visual acuity was similar in the control, +2.75 D add, and +3.25 D add IOL groups
(–0.01, 0.01, and 0.02), and there was also no
significant difference between groups in mean
logMAR best-corrected visual acuity at distance (–0.09, –0.07, and –0.06).
However, compared with the control group,
patients with the +2.75 D and +3.25 D add
IOLs implanted had significantly better uncorrected near visual acuity (tested at 40 cm) (0.14
and 0.10 versus 0.44) and distance-corrected
near visual acuity (0.17 and 0.11 versus 0.49).
Analyses of directed reports of optical/visual symptoms showed none of the patients
in the control group was completely spectacleindependent, whereas 61.3% of patients with
the +2.75 D add IOL implanted and 75.0% of
those with the +3.25 D add IOL implanted
said they never wear glasses.
Almost one-third of control patients said
they either wore no glasses for near or wore
23
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
SURGICAL BENEFITS
VIDEO Keith Walter, MD, discusses his
surgical experience with the low-add multifocal IOL
models. Go to https://youtu.be/TR8oAhBkRvA
them less than half the time, and those levels
of spectacle independence were achieved by
nearly 90% of patients in both of the multifocal IOL groups. Overall satisfaction with vision without glasses was expressed by 85.6%
of controls, 97.2% of the +2.75 D add patients,
and 93.3% of +3.25 D add patients.
In response to direct questioning, moderate
to severe difficulty with halos was reported by
TECHNOLOGICAL ADVANCES IN
16% of control patients, 31% of patients with
the +2.75 D add IOL, and 43% of those with
the +3.25 D version. There was less of a difference between the control and +2.75 D and
+3.25 D add multifocal IOL groups in rates of
moderate to severe difficulty with glare/flare
(19% versus 23% and 31%).
When specifically asked about difficulty
with night vision, fewer patients had moderate to severe difficulty with night vision in
the +2.75 D add multifocal group than in the
+3.25 D add multifocal and even the control
group (9% versus 16% and 14%, respectively).
“Within 1 to 2 weeks after surgery, patients
with the low-add . . . multifocal IOLs had little problems with halos and night vision,” Dr.
Chang said. “This rapid neuroadaptation phase
seems to occur especially with the +2.75 D add
version. For that reason, more-demanding patients may particularly benefit from that lens.”
The new low-add versions also offer an opportunity for customizing implant decisions
using a different add power of the multifocal
IOL in the second eye, if indicated by patient
preference after the first eye surgery.
IOLs
“Almost all patients are very happy with
their vision after the first surgery and go on
to receive the same IOL in the fellow eye,” he
said. “Occasionally, however, someone desires
a slightly different profile of near and intermediate vision.”
This type of variation in near focal points
can occur unintentionally when implanting
the same add multifocal IOL in both eyes as
the result of a slight difference in refractive
outcomes, Dr. Chang noted.
“We know that patients typically do fine
in that situation, and sometimes we even did
that intentionally,” he said. “Now with the
different versions of [this] multifocal IOL we
can approach this type of customization while
still targeting a plano refraction in both eyes
for the best distance vision.” ■
DANIEL H. CHANG, MD
E: [email protected]
This article was adapted from Dr. Chang’s presentation at the 2015 meeting of the
American Society of Cataract and Refractive Surgery. Dr. Chang is a paid consultant for
Abbott Medical Optics.
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24
JUNE 1, 2015 :: Ophthalmology Times
Special Advertising Section
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JUNE 1, 2015 :: Ophthalmology Times
Special Advertising Section
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JUNE 1, 2015 :: Ophthalmology Times
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27
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Enhanced injector for hydrophobic
acrylic IOL yields greater control
Updated device has longer plunger with polished, softened plunger tip to reduce resistance
By Nancy Groves; Reviewed by Anil M. Shivaram, MD
softened plunger tip to reduce resistance between it and the lens.
Though the previous version of the injeca lens injector system (BLIS Injector System,
Bausch + Lomb)—designed for use with a tor system was left-biased to increase comglistening-free hydrophobic acrylic IOL (en- pression on the haptic, the plunger tip has
Vista, Bausch + Lomb)—add up to huge im- been repositioned and centered to instead reprovements compared with the original sys- duce pressure in the optic-haptic junction. A
slight downward angulation has been added
tem, said Anil M. Shivaram, MD.
to make sure the trailing haptic
“The previous iteration of the
stays within the folded portions
delivery system was not as optiof the optic but without creating
mized as it could be in terms of
stress on that junction.
the delivery of the lens,” said Dr.
The external finish was also
Shivaram, an ophthalmologist in
Modifications to
changed to provide more tactile
Claremont, CA, who has performed a reusable injector
feedback, a feature many surgeons
more than 80 procedures with the system have reduced
appreciate, Dr. Shivaram said.
recently released updated injec- resistance between the
With any lens injector system,
tor. “I think [the manufacturer] plunger tip and the IOL,
surgeons can potentially lose conwas getting feedback from myself creating a smoother
trol of the lens. This can happen,
and a number of other surgeons delivery of the lens into
for example, when there is too little
that they wanted to maximize the the eye.
viscoelastic in the cartridge, causutility of the delivery system with
the idea that eventually there will be an array ing air pockets and forcing the lens to express
faster than expected into the eye. The updated
of lenses that can be used with it.”
device ensures controllable, repeatable deliveries with little to worry about, he noted.
NEW FEATUR ES
“It allows for minimizing that uncontrolled
One change is a longer plunger. With the additional 2 mm of length, it is easier for the delivery,” Dr. Shivaram said. “You get a nice,
surgeon to “dunk” and manipulate the lens smooth delivery of the lens without placing
when it is in the capsular bag, according to a lot of tension on the optic-haptic junction.”
The injector can be used through incisions
Dr. Shivaram.
The modified injector also has a polished, as small as 2.2 mm, he noted.
CL AREMON T, CA ::
A SERIES OF SMALL modifications to
take-home
ALIGNMENT
( Continued from page 21 )
meeting ANSI criteria for toric lens stability.3
This translates into excellent visual acuity results (Figure 2 on Page 20).
Surgical technique plays a role in the stability
and performance of toric IOLs as well. I prefer
to use a cohesive viscoelastic. It is important
not to over-pressurize the eye. The lens can be
injected counterclockwise of its final position
and then dialed into correct alignment with
the axis marks. Once aligned, I push the IOL
gently against the posterior capsule.
Finally, all of the ophthalmic viscosurgical device must be carefully removed from
behind the lens.
With this approach of careful preoperative measurement and marking, intraoperative marking and alignment, and good surgical technique, surgeons can achieve success
with toric IOLs to the benefit of their practices
and their patients with astigmatism. ■
The enhanced injector system now includes a
softened and tumble-polished plunger tip that
is 2-mm longer than the previous design, which
helps facilitate easier placement in the capsular
bag. (Photo courtesy of Bausch + Lomb)
Watch the ease of delivery with the injector
system. Go to http://bit.ly/1FzQBF8
(Video courtesy of Anil M. Shivaram, MD)
Based on his experience with the new system, the changes have optimized delivery of
the lens, Dr. Shivaram said.
Although currently only used with one IOL
model, the recent improvements in the injector system and any future modifications could
eventually extend its utility to an entire family of lenses, he added. ■
ANIL M. SHIVARAM, MD
E: [email protected]
Dr. Shivaram is a consultant for Bausch + Lomb.
References
1. ASCRS Clinical Trends Survey 2014. Survey
overview available online at: http://eyeworld.org/
supplements/2014_ASCRS_clinical_survey.pdf
2. Ma JJ, Tseng SS. Effects of steep meridian incision on
corneal astigmatism in phacoemulsification cataract
surgery. J Cataract Refract Surg. 2012;38:666-671.
3. TECNIS Toric 1-Piece IOL [package insert]. Santa
Ana, CA: Abbott Medical Optics Inc.
JOHN A. VUKICH, MD
E: [email protected]
Dr. Vukich is surgical director, Davis Duehr Dean Center for Refractive
Surgery, Madison, WI. He is a consultant to Abbott Medical Optics.
28
JUNE 1, 2015 :: Ophthalmology Times
Special Report )
TECHNOLOGICAL ADVANCES IN
IOLs
Fluid-filled accommodative IOL shows
stable visual function over 18 months
Lens design exhibits ‘true accommodation’ in pilot study; moves into multicenter study
By Lynda Charters; Reviewed by Louis D. “Skip” Nichamin, MD
AVON, CO ::
A NOVEL FLUID-BASED accommodative IOL (FluidVision, PowerVision Inc.) is
in an ongoing multicenter study after having
demonstrated the lens design goal of “true accommodation” in a pilot study,
with stable results out to 18
months, said Louis D. “Skip”
Nichamin, MD.
True accommodation is defined as the ability to see at
near and distance seamlessly
Dr. Nichamin
and to maintain the natural
mechanism of accommodation, according to
Dr. Nichamin, in private practice in Avon, CO.
About the lens design
> Optic diameter: 6.0 mm
> Overall diameter: 10 mm
> Haptics height: 3.0 mm
> Refractive index = 1.48
> The optic is suspended between
the haptics
The lens body of the fluid-based accommodative technology is made from hydrophobic acrylic. The lens and
hollow optics are filled with index-matched silicone fluid. Movement of fluid from the haptics to the optic
produces large increases in optical power. (Figures courtesy of Louis D. “Skip” Nichamin, MD)
near and intermediate visual acuity, according to Dr. Nichamin, who is a medical advisor
PI LOT ST U DY
to PowerVision.
The pilot study enrolled 20 patients with the lens
“No clinically relevant complications were
implanted at one site in Pretoria, South Africa. associated with the implantation of the IOL,”
Two surgeons performed all of the monocu- he said. “Implantation of this accommodative
lar implants. Patients were followed at 1 day, IOL is comparable to a standard IOL implan1 and 2 weeks, and 1, 3, 6, 12, and 18 months tation procedure.
postoperatively to evaluate the accommoda“The objective accommodation met the Intion and accommodative amplitude.
ternational Organization for Standardization
The study evaluated refining the implant guidelines to be labeled an accommodative IOL
technique, selecting and refining the accom- and subjectively, the patients who are best-cormodation measurement techniques, and dem- rected for distance see far, intermediate, and
onstrating the safety of the lens.
near and can read without supAt 6 months postoperatively,
plemental correction,” Dr. Nichaall patients had excellent distance
min said.
best-corrected visual acuity (averThe excellent distance refracage, 20/19) and very good intertion demonstrates the high optiFluid-based
mediate and near visual acuities
cal quality of the lens, according
of 20/26 and 20/33, respectively. accommodating IOL
to Dr. Nichamin.
Visual acuity remained stable out technology achieved
to 18 months in the study patients, “true accommodation”
ABOUT THE
in a pilot study. A
Dr. Nichamin noted.
TECHNOLOGY
The average accommodation by multicenter study of the As background, the body of the
the “push-down method” was 3+ lens is ongoing.
lens is made from a proprietary
take-home
D, as was its defocus range. Both of
these measurements remained stable throughout the follow-up period. Patients also showed
an average of 2.5 to 3 D of accommodation
when induced by pilocarpine.
Measurement of visual acuity in a small
subset of patients who underwent binocular
implantation showed an average of one additional line increase in best distance-corrected
hydrophobic acrylic. The lens and
hollow haptics are filled with a proprietary
index-matched silicone fluid.
The act of accommodation forces fluid from
the haptics into the optic, which increases the
optic thickness and optical power. During disaccommodation, the fluid flows back into the
haptics and the optical power decreases.
The lens is 10 mm in overall diameter with
an optic that is 6 mm in diameter. The haptics are 3 mm high and the refractive index is
1.48. In this IOL, the optic is suspended between the haptics.
The lens is an investigational device and is
not available for sale or use in the United States.
M U LT IC E N T E R ST U DY
The multicenter study—being performed at
seven centers in South Africa and Germany—
began in January and April 2014, respectively,
with a goal of completing 115 implantations.
In South Africa, phacoemulsification was
performed with manual curvilinear capsulorhexes (CCCs).
In Germany, the procedures are being performed with both manual CCCs and femtosecond laser. Sixty-eight of the 115 implants
were completed with 4-mm insertion, and the
remainder will be performed with a 3.5-mm
insertion system. ■
Join the discussion on fluid-based
accommodative IOL technology at
Facebook.com/OphthalmologyTimes
LOUIS D. “SKIP” NICHAMIN, MD
E: [email protected]
Dr. Nichamin is a medical advisor to PowerVision Inc. and has no financial interest in
any surgical instrument mentioned in this report.
29
practice management
JUNE 1, 2015 :: Ophthalmology Times
Running a ‘perfect' clinic
A lesson from the sports world: Sometimes good for all is better than perfect for one
Putting It In View By Dianna E. Graves, COMT, BS Ed
can be considered a “sportsaholic”—
cally throughout the week, and began to
no matter what season of the year,
have an understanding of what Greenberg
I will be fixated on a sport and the
might have meant as it related to my world.
We have recently changed lead techniteams/politics involved. Baseball
cians/lead locations in six of our clinics,
owns my heart. While most folks
and while it has gone relatively smooth
bravely trudge through one Fanin the past month, I am betasy Baseball team, I
ginning to see the “shine”
proudly manager three!
wear off.
Every morning on my
When you make a large
way to work, I am glued to
As staff members
clinic
change, there will be a
the radio—making sure to
develop in new roles,
grace
period
where tolerance
get the latest updates on the
managers should
of
all
the
staff
will be high.
games played last night and
coach and counsel
Misjudgments,
miscalculathe pundit’s philosophies of
them so that they
tions,
overreactions
to situathe teams in question.
are thinking and
tions,
and
napoleonistic
beOne show I listen to is the
making decisions
havior
is
often
overlooked
or
“Mike & Mike” Show, with
in a global manner,
diminished,
and
all
sins
are
Mike Greenberg and Mike
not an individual
quickly forgiven. This can
Golic. They have good banmanner.
also be called the “honeyter, comedic discussions,
moon period.”
and excellent analysis of
sports. Greenberg plays the
absolute antithesis of a “rough-and-tumble
THE BR ANCHING-OUT PHASE
athlete,” and Golic is the ex-football player
Then we begin to see the branching-out
who “has done all that.”
phase. This is where staff members—feelOne day, they were having a passionate
ing comfortable with their new roles—begin
discussion of a recent game, and Greenberg
flexing their wings.
called out in angst the following statement:
An example of this occurred as I was
“Don’t let perfect be the enemy of good”
trying to make a staffing change on the
(originally credited to Voltaire).
fly—literally, I was at the airport running
I arrived at work, shut off the radio, and
between gates to connect with my next
entered my own “sports arena” of clinic life.
flight—because we had a last-minute sick
I thought back on this statement periodicall in the clinic.
I
TAKE-HOME
Shawn, my new “right-hand” lead, informed me of this spur-of-the-moment sick
call. Using this as a teaching moment for
Shawn, we began reviewing the situation
and what it meant throughout the system:
> We needed to look at four other clinics and
the dynamics of those clinics, and also the
clinic that was now short . . . as well as the
lead running that clinic.
> We looked at the dynamics/demeanor of
the physicians at the short clinic.
I decreed that one of the technicians,
Sara, needed to leave Shawn’s clinic and go
to the clinic that was now short. Shawn was
to inform Sara, and the case was closed. Or
so I thought.
Fifteen minutes later, Shawn called to tell
me that instead of sending Sara, she had
sent Peggy.
I was angry for a number of reasons, but
tried to temper this so I could try and help
Shawn understand the many errors of her
ways. She felt she had made an educated decision. While it was educated—it was also ill
timed, slightly ulterior, and poorly executed.
Peggy is a sweet-tempered and patient
technician, but she is newer and still slow
with her skills. Going into that fast-paced,
crazy clinic was not what I had envisioned.
Basically, it was a very poor move and it set
Sara up for a pretty scary morning.
Continues on page 30 : Clinic
OT columnist Grande joins Wells Fargo ‘Premier Advisor’ program
OAK HURS T, N J ::
WELLS FARGO Advisors Financial Network has designated John S. Grande, CFP, registered principal, as a member of the firm’s
Premier Advisors Program.
The distinction reflects Grande’s achievement of professional success by meeting or exceeding Wells Fargo Advisors Financial Network’s high standards as measured by one
or more of the milestones for revenue generation, educational attainment, and clientservice best practices, said Wells Fargo in a
prepared statement.
Grande is a long-time contributor to Ophthalmology Times’ “Money Matters” column,
along with father, John J. Grande, CFP, and
mother, Traudy F. Grande, CFP. In addition,
Grande has been published in numerous medi-
cal journals and has lectured at Johns Hopkins
University School of Medicine, Baltimore, as
well as other medical associations.
He has been a financial advisor with Wells
Fargo Advisors Financial Network for 3 years
and has 20 years’ experience in the brokerage
industry. Grande holds a bachelor’s degree in
business and economics from Lehigh University, Bethlehem, PA. ■
30
JUNE 1, 2015 :: Ophthalmology Times
practice management
CLINIC
( Continued from page 29 )
WHAT WENT WRONG?
While you might feel it is good to have the
lead thinking ahead, what she really did
was:
> Look at how her clinic was being slightly
stretched, and decided to keep the strong
technician (Sara) that I was sending away
and instead sent the “weaker” technician
(Peggy)—thereby, her clinic remained strong
and “excellent.”
> Involve two other clinics (making a complicated four-way switch versus just a simple
two-way switch). Now there were technicians
all over the road in the early-morning, rushhour traffic.
> Put a new person, who was being sent to
“save the day” in the potential line of fire.
> Override me, and then informed me of it
after the fact. There was no changing it after
it was done.
Throughout the day, a discussion commenced of where Shawn had gone astray,
my perception of why she did this, and the
errors of her thinking.
I absolutely need and want her to be
thinking and making decisions, but in a
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7, 11-12, 19
Every time you call a clinic, Angie, a
global manner not an individual manner,
general technician, answers the phone inthereby ensuring her clinic world was runstead of the lead technician. When you ask
ning perfectly.
where the lead is, you are told that he or
Instead of everyone having a chance to
she is in a room seeing a patient. When
run “good” on this crazy morning, she jetyou ask the lead why the general technitisoned two clinics so they ran minimally
“fair” and then ensured her clinic ran
perfectly. Sometimes
good for all is better
than perfect for one.
The leads/managers will begin to do
things quietly below
the radar to ensure
their clinics run
smoothly, and that
— Dianna E. Graves, COMT, BS Ed
they remain basking
in the glow of success, even if it is at
cian is always answering the phone or the
the downfall of someone else. This cannot
physician’s bell, the reply will be: “We were
be allowed to occur
behind, and I am faster than them, so I
had them ride the desk.”
THE BIG PICTUR E
Instead of correcting, mentoring, and adManagers/leads need to be thinking convising Angie to improve her speed, the lead
stantly of the whole picture and not just the
“hides” her at the desk and pushes her to
small, individual frames of snapshots.
the side. All is well, but Angie is failing.
I am not saying these are heinous, preLastly, there are going to be times when
meditated acts to tank other leads—beall hell is going to break loose. It happens!
cause they aren’t. It is human nature to
Help the leads understand it is just a ripsurvive, and to them, they are simply surple in the water, and help them learn how to
viving. You may see another example in
get out of the nightmare day they are havthis instance:
ing. Teach them how to raise the white flag
and how to re-assess what has occurred.
Being oblivious to it, or trying to hide it,
is like putting a pink dress and high heels
on a grizzly. While you may be able to dress
Advertiser
Page
it up, you still have an angry bear running
Doheny Eye Institute
17
around in the clinic.
www.doheny.org
When I return from the weekend, Shawn
and
I will need to go have breakfast and disKatena Products Inc.
21
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cuss why she received my wrath. We will
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discuss that while “good” would have been
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the best outcome for all involved, she had
basked in the glow of “excellent” at the sake
Marco
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of her fellow technicians.
I am sure there will need to be a Bloody
Ocular Therapeutix
CV3
Mary
involved as the first course—at least
P: 781/357-4062
for me! ■
‘Managers need to be thinking
constantly of the whole picture
and not just the small, individual
frames of snapshots.’
This index is provided as an additional service.
The publisher does not assume any liability for errors
or omissions.
OPHTHALMOLOGY TIMES (Print ISSN 0193-032X, Digital ISSN 2150-7333) is published semimonthly except for one issue in Jan, May, Aug and Dec (20 issues yearly) by UBM Medica,
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Permission Dept. fax 440-756-5255 or email: [email protected].
DIANNA E. GRAVES, COMT, BS ED
E: [email protected]
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.
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TECNIS® 1-Piece IOLs1-10
Indications and Important Safety Information — TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery System
Rx ONLY
ATTENTION: Reference the Directions for Use for a complete listing of indications and important safety information.
INDICATIONS: Abbott TECNIS® 1-Piece IOLs are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction.
These devices are intended to be placed in the capsular bag. WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the
Directions for Use that could increase complications or impact patient outcomes. Do not attempt to disassemble, modify or alter the device or any of its components. Do not use methylcellulose
viscoelastics with the device. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for
lens implantation. Discard if the lens has been fully advanced for more than 1 minute. The lens should not be placed in the ciliary sulcus. PRECAUTIONS: Do not reuse, resterilize, reprocess, or
autoclave the device. Do not store in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). The recommended temperature for implanting the lens is at least 17°C. Low operating
room temperatures combined with high IOL diopter powers may require slower delivery. The use of viscoelastics is required when using the device. The use of balance salt solution alone is not
recommended. Do not use if the device has been dropped or if any part was inadvertently struck while outside the shipping case. ADVERSE EVENTS: The most frequently reported adverse event that
occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%.
References
1. TECNIS® 1-Piece Intraocular Lenses [package insert]. Santa Ana, Calif.: Abbott Medical Optics Inc. 2. Terwee T, van der Mooren M, Piers P. Optical performance of TECNIS IOLs compared with IOLs that partly
compensate for the mean SA of the human cornea. Presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; April 4-9, 2008; Chicago, Ill. 3. Data on file 150. Abbott Medical Optics Inc.
4. Zhao H, Piers PA, Mainster MA. The additive effects of different optical design elements contributing to contrast loss in pseudophakic eyes implanted with different aspheric IOLs. Presented at: 27th Congress of the
European Society of Cataract and Refractive Surgeons; September 4-8, 2008; Barcelona, Spain. 5. Zhao H, Mainster MA. The effect of chromatic dispersion on pseudophakic optical performance. Br J Ophthalmol.
2007;91(9):1225-1229. 6. Mainster MA. Violet and blue-light blocking intraocular lenses: photoprotection versus photoreception. Br J Ophthalmol. 2006;90:784-792. 7. Nixon DR. New technologies for premium
outcomes: next generation phaco and TECNIS® 1-Piece IOL. Presented at: 25th Congress of the European Society of Cataract and Refractive Surgeons; September 8-12, 2007; Stockholm, Sweden. 8. Sacu S,
Menapace R, Buehl W, Rainer G, Findl O. Effect of intraocular lens optic edge design and material on fibrotic capsule opacification and capsulorhexis contraction. J Cataract Refract Surg. 2004;30:1875-1882. 9. Boyce
JF, Bhermi GS, Spalton DJ, El-Osta AR. Mathematical modeling of the forces between an intraocular lens and the capsule. J Cataract Refract Surg. 2002;28(10):1853-1859. 10. Peng Q, Visessook N, Apple DJ, et al.
Surgical prevention of posterior capsule opacification. Part 3: Intraocular lens optic barrier effect as a second line of defense. J Cataract Refract Surg. 2000;26(2):198-213.
TECNIS and TECNIS iTec are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates.
©2015 Abbott Medical Optics Inc. | www.AbbottMedicalOptics.com | PP2015CT0445