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Vision quest

By Lynda Charters

Reviewed by Eric D. Donnenfeld, MD, Peter S.

Hersh, MD, and Marguerite McDonald, MD

The most important advance in refractive

surgery in 2010 that is being touted by sur-

geons is femtosecond technology for laser

cataract surgery and the creation of LASIK flaps,

which by all accounts will raise the bar for visu-

al outcomes. Surgical advances also have been

observed in the treatment of keratoconus and

other corneal disorders and presbyopia.

And an avalanche of new dry eye, anti- allergy,

anti-inflammatory, and anti-viral medications

entered the marketplace. Three surgeons who

are specialists in refractive surgery, cornea, and

cataract weighed in on the year’s developments

as they apply to refractive outcomes.

By far the biggest step forward in technology

this past year has been the development and

emergence of femtosecond cataract surgery. Eric

D. Donnenfeld, MD, described this as “an exciting

and rather unexpected innovation” that, he be-

lieves, is a “transformative mo-

ment in cataract surgery and

ophthalmology in general that

likely will change the way pro-

cedures are performed.

“This is indeed a major story

for the next decade because

cataract surgery is now moving in a different

direction for the first time since the introduc-

tion of phacoemulsification,” he said.

Refractive review

Femtosecond at forefront in 2010Laser technology expected to raise the bar for visual outcomes, increase level of comfort

Dr. Donnenfeld

December 15, 2010VOL. 35, NO. 24

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Vision quest

By Cheryl Guttman Krader

Reviewed by Douglas D. Koch, MD

Chicago—Developments in techniques and technology are enabling the

quest for the perfect cataract operation. However, as surgeons move

toward this goal over the next decade, they will face a number of so-

cial, socioeconomic, and financial issues.

In his delivery of the Kelman Lecture at the annual meeting of

the American Academy of Ophthalmology, Douglas D. Koch, MD, bor-

rowed from the words of Charles Kelman, MD, in encouraging his

colleagues along a path of success.

“Dr. Kelman wrote: ‘It becomes a matter of selecting the possible

impossible dream . . . evaluating your own aspirations, not setting

Physician shares view on factors influencing the mission for perfect cataract surgery

Kelman Lecture

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Ophthalmology Times Mission Statement

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community, and reporting those issues and their potential outcomes to our readers.

Editorial Advisory Board

Chief Medical Editor

Peter J. McDonnell, MDWilmer Eye InstituteJohns Hopkins University Baltimore, MD

Associate Medical Editors

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Allen C. Ho, MDWills Eye Institute, Thomas Jefferson University, Philadelphia, PA

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Randall Olson, MDUniversity of Utah, Salt Lake City, UT

Robert Osher, MDUniversity of Cincinnati, Cincinnati, OH

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email: [email protected].

Anterior Segment/Cataract

Cornea/External Disease

Ashley Behrens, MDWilmer Eye Institute, Johns Hopkins UniversityBaltimore, MD

Rubens Belfort Jr., MDFederal University of São PauloSão Paulo, Brazil

Elizabeth A. Davis, MDUniversity of Minnesota, Minneapolis, MN

Uday Devgan, MD

Jules Stein Eye Institute/UCLA

Los Angeles, CA

I. Howard Fine, MDOregon Health & Science UniversityPortland, OR

Howard V. Gimbel, MDGimbel Eye Centre, Calgary, Canada

Richard S. Hoffman, MDOregon Health & Science University, Portland, OR

Jack T. Holladay, MD, MSEE, FACSBaylor College of Medicine, Houston, TX

Manus Kraff, MDNorthwestern University, Chicago, IL

Samuel Masket, MDJules Stein Eye Institute/UCLA, Los Angeles, CA

Bartly J. Mondino, MDJules Stein Eye Institute/UCLA, Los Angeles, CA

Mark Packer, MDOregon Health & Science University, Portland, OR

Walter J. Stark, MDWilmer Eye Institute, Johns Hopkins UniversityBaltimore, MD

Glaucoma

Robert D. Fechtner, MDUniversity of Medicine & Dentistry of New JerseyNewark, NJ

Neeru Gupta, MDUniversity of Toronto, Toronto, Canada

Jeffrey M. Liebmann, MDManhattan Eye, Ear & Throat HospitalNew York, NY

Richard K. Parrish II, MDBascom Palmer Eye Institute, University of MiamiMiami, FL

Harry A. Quigley, MDWilmer Eye Institute, Johns Hopkins UniversityBaltimore, MD

Robert Ritch, MDNew York Eye & Ear Infirmary, New York, NY

Joel Schuman, MDUniversity of Pittsburgh Medical Center Pittsburgh, PA

Kuldev Singh, MDStanford University, Stanford, CA

George L. Spaeth, MDWills Eye Institute, Thomas Jefferson UniversityPhiladelphia, PA

Robert N. Weinreb, MDHamilton Glaucoma CenterUniversity of California, San Diego

Neuro-Ophthalmology

Andrew G. Lee, MDMethodist Hospital, Texas Medical CenterHouston, TX

Oculoplastics/

Reconstructive Surgery

Richard L. Anderson, MDCenter for Facial Appearances, Salt Lake City, UT

Robert Goldberg, MDJules Stein Eye Institute/UCLA, Los Angeles, CA

John T. LiVecchi, MDSt. Luke’s Cataract & Laser InstituteTarpon Springs, FL

Shannath L. Merbs, MDWilmer Eye Institute, Johns Hopkins UniversityBaltimore, MD

Pediatric Ophthalmology

Norman B. Medow, MDManhattan Eye, Ear & Throat HospitalNew York, NY

Jennifer Simpson, MDUniversity of California, Irvine Irvine, CA

H. Jay Wisnicki, MDNew York Eye & Ear Infirmary, Beth Israel Medical Center/Albert Einstein College of MedicineNew York, NY

Refractive Surgery

Eric D. Donnenfeld, MDNew York University Medical CenterNew York, NY

Daniel S. Durrie, MDKansas City, KS

Kenneth A. Greenberg, MDDanbury Hospital, Danbury, CT/ New York University, New York, NY

Peter S. Hersh, MDUniversity of Medicine & Dentistry of New JerseyNewark, NJ

Ioannis G. Pallikaris, MDUniversity of Crete, Crete, Greece

Theo Seiler, MDUniversity Hospital of Zurich, Zurich, Switzerland

Jonathan H. Talamo, MDHarvard University, Boston, MA

George Theodossiadis, MDAthens, Greece

Kazuo Tsubota, MDKeio University School of Medicine, Tokyo, Japan

George O. Waring III, MDAtlanta, GA

Retina/Vitreous

Mark S. Blumenkranz, MDStanford University, Stanford, CA

Neil M. Bressler, MDWilmer Eye Institute, Johns Hopkins UniversityBaltimore, MD

Stanley Chang, MDColumbia University, New York, NY

David Chow, MDUniversity of Toronto, Toronto, Canada

Sharon Fekrat, MDDuke University, Durham, NC

Stuart Fine, MDUniversity of Pennsylvania, Philadelphia, PA

Julia Haller, MDWills Eye Institute, Thomas Jefferson UniversityPhiladelphia, PA

Hilel Lewis, MDColumbia University, New York, NY

Carmen A. Puliafito, MDKeck School of Medicine, USC, Los Angeles, CA

Carl D. Regillo, MDWills Eye Institute, Thomas Jefferson UniversityPhiladelphia, PA

Lawrence J. Singerman, MDCase Western Reserve University, Cleveland, OH

Lawrence Yannuzzi, MDManhattan Eye, Ear & Throat HospitalNew York, NY

Uveitis

Emmett T. Cunningham Jr., MD, PhDStanford University, Stanford, CA

Chief Medical Editors-

Emeritus

Jack M. Dodick, MDNew York University School of MedicineNew York, NY (1976-1996)

David R. Guyer, MD

New York, NY (1996-2004)

Official publication sponsor of

3

editorial advisory boardeditorial advisory boardDECEMBER 15, 2010 / www.ophthalmologytimes.com

http://www.rheinmedical.com

Editorial

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Contributing Editors

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Cheryl Guttman Krader, Ron Rajecki, Jennifer A. Webb

Column Editors

Anterior Segment Techniques Ernest W. Kornmehl, MD

Cataract Corner Richard S. Hoffman, MD and

Mark Packer, MD

coding.doc L. Neal Freeman, MD, MBA

Dispensing Solutions Arthur De Gennaro

Grand Rounds Robert Ritch, MD

Money Matters John J. Grande, Traudy F. Grande, and John S. Grande, CFPs®

Neuro-Ophthalmology Andrew G. Lee, MD

Ophthalmic Heritage Norman B. Medow, MD

Panretinal View Allen C. Ho, MD

Plastics Pearls Richard Anderson, MD

Tech Talk H. Jay Wisnicki, MD

Uveitis Update Emmett T. Cunningham Jr., MD, PhD, MPH

What’s New at the AAO John Gallagher

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DECEMBER 15, 2010 ◾ VOL. 35, NO. 24

editorialeditorial4

“Here Bygynneth the Book of the Tales of

Canterbury

When the soft sweet showers of April reach the

roots of all things, refreshing the parched earth, nour-

ishing every sapling and every seedling, then human-

kind rises up in joy and expectation. The west wind

blows away the stench of the city and the crops flour-

ish in the fields beyond the walls. After the waste of

winter, it is delightful to hear birdsong once more in

the streets. The trees themselves are bathed in song. It

is a time of renewal, of general restoration.”Chaucer G, Ackroyd P (retold by). The Canterbury Tales, A retelling.

NY: Viking Penguin; 2009.

Written in the 14th century, “The Can-

terbury Tales” is considered one of the

greatest poems in all of English litera-

ture. It tells the story of a group of strangers who

travel together on a pilgrimage, entertaining each

other with colorful tales.

My favorite part is the beginning, quoted above,

that beautifully describes the return of Spring.

Now that the weather in my part of the coun-

try has been dipping near freezing, anticipating

the change of seasons so beautifully described by

Chaucer gives us something great to look forward

to. It is this lack of beauty in spring’s arrival that

makes so many in relatively uniform climes (e.g.,

southern California and Florida) feel that they are

really missing out on life.

The other aspect of beautiful poetry, of course,

is that it makes us realize that most of what

we read is not beautiful or inspiring. Most of

the medical literature we plow through is fairly

dense, written in scientific style, with lots of pas-

sive voice (“it is well known that . . . .”). In short,

we read a lot of literature that can be described

as quite dry or (less charitably) painfully boring.

It was not always thus. For example, Jonas

Friedenwald, MD—a famous Baltimore ophthal-

mologist—published a paper in 1932 that de-

scribed a fisherman getting a chemical burn of

the eye from fish bile while cleaning his catch.

The article begins: “The road of science is a

tortuous one, that twists and turns and not in-

frequently crosses some of the most ancient foot-

paths. We were, therefore, much interested to

discover, when we had completed the studies

that are the subject of the paper, that our ideas

had been anticipated by an ancient observer

some two thousand years ago . . . .”1

Arnall Patz, MD, who passed away earlier this

year, had described this as “an example of the el-

oquent style and sharp wit that would appear in

many of [Dr. Friedenwald’s] future publications.”2

When was the last time you read a scientific

paper that struck you as eloquent, or that con-

tained anything resembling the soaring rhetoric

that we today tend to associate with politicians

and perhaps lawyers, but not physicians?

In 1900, an article in the American Journal of

Ophthalmology described a “brilliant” eye surgeon,

George Critchett, who used poetry as a sedative

while removing cataracts: “It was an interesting

and refreshing sight to see the talented and ever-jo-

vial Mr. Critchett recite Shakespeare or some other

poetry while performing an operation; he almost

invariably succeeded in diverting the patient’s at-

tention from the surgical work as if casting a

charm over him by the beautiful recitations.”3

The question in the mind of today’s ophthal-

mologists, upon learning of Critchett’s technique,

is “Is there a modifier for intraoperative poetry?”

Perhaps we should try to encourage more in-

teresting writing in our ophthalmic publications.

Akin to that found in “The Canterbury Tales.”

But not as interesting as “The Miller’s Tale.”OT

References 1. Verhoef FH, Friedenwald JS. Injury to cornea and

conjunctiva due to fish bile. Am J Ophthalmol. 1932;5:857.

2. Patz A. Jonas Friedenwald, man of science. Inv Ophthalmol

Vis Sci. 1980;19:1139.

3. Pollak S. Personal recollections of early cataract

extractions. Am J Ophthalmol. 1900;17:36.

Waxing poetic

Tales of Canterbury and eye surgery

By Peter J. McDonnell, MD

director of the Wilmer Eye Institute,

Johns Hopkins University School of

Medicine, Baltimore, and chief medical

editor of Ophthalmology Times.

He can be reached at 727 Maumenee Building

600 N. Wolfe St. Baltimore, MD 21287-9278

Phone: 443/287-1511 Fax: 443/287-1514

E-mail: [email protected]

http://www.gene.com

By Jennifer A. Webb

Dublin, CA—The newest version of a biometer

that some call the industry’s gold standard

makes it possible to measure axial length

through dense cataracts

quickly and easily prior to

cataract surgery without

having to resort to immer-

sion ultrasound.

The device (IOLMaster

500, Carl Zeiss Meditec),

which received FDA market-

ing clearance last month (Nov. 8), also allows

technicians to calculate keratometry and axial

length simultaneously to help physicians select

the optimal IOL following cataract removal.

“This newer version is light years better than

the initial versions of the [device],” said Alice

Epitropoulos, MD, assistant clinical professor

at The Ohio State University and a cataract

specialist in Columbus, OH, who has used the

biometer since June.

When the original device was launched in

2000, it was the first automatic biometry sys-

tem available that did not make contact with the

patient’s eye. Today, there are more than 11,000

units in use worldwide, said a Carl Zeiss Med-

itec spokeswoman.

“There’s no question that the IOLMaster is

the gold standard,” Dr. Epitropoulos said.

Advanced capabilitiesThis newest version, developed over the past

11 years, is able to complete all measurements

in as little as 80 seconds, according to a sin-

gle-practice study conducted by Oliver Findl,

MD, of Vienna, Austria.

In addition, a composite signal filtering tech-

nology excludes poor readings and increases

the percentage of cataract patients that can

be measured.

“By using sophisticated signal-to-noise

analysis, the software is able to exclude bad

readings [automatically] and create a com-

posite best measurement for each eye,” said

Dr. Epitropoulos, who noted her practice was

the first in the United States to use the in-

strument. “This composite technology that’s

incorporated in the [device] has significantly

increased the fraction of cataracts measur-

able. Instead of measuring an average of all

the measurements, the [biometer] uses digi-

tal processing technology to calculate an ac-

curate composite reading. Statistical noise is

detected and filtered.”

Should a cataract appear too dense to be

measured with the device, patient data are

integrated easily with a separate ultrasound

system (A-Scan Synergy) that uniquely trans-

fers data to and from the biometer.

Additional software (Option Sonolink) can

be purchased to allow these two devices to

communicate, said Mely Medel, senior market

development manager of Carl Zeiss Meditec’s

cataract and refractive diagnostics group.

The seamless integration means patient data

do not have to be re-entered, saving time and

reducing opportunities for errors, Dr. Epitro-

poulos said.

Once the ultrasound measurement is com-

plete, A-scan data are imported by the device

for IOL power calculation.

“That’s a significant advantage,” Dr. Epitro-

poulos said. “In the past, optical biometry was

known for not being able to get through those

dense cataracts, then you have to break your

flow and schedule for ultrasound, which is

inconvenient for patients.”

The data are calculated using a range of for-

mulas, including the fourth-generation Haigis

formula. The system also is designed to trans-

fer easily to the Holladay Consultant Program,

Dr. Epitropoulos said.

“I often use the Holladay II formula, es-

pecially with shorter eyes,” Dr. Epitropou-

los said, noting that typically, the formula

requires manual input of several variables.

“It is considered by many to be the most ac-

curate of the theoretic formulas available.

It works well across a wide range of axial

lengths and is easy to optimize.

“The [device] facilitates direct data export

so you can use the Holladay II formula,” she

added.

Technologic featuresA simple green, yellow, and red “traffic light”

system lets technicians know when patients’

eyes are aligned properly, increasing techni-

cians’ confidence that accurate readings are

being taken and ultimately shortening the “seat

time” for patients. Technicians accustomed to

using the biometer will require very little train-

ing on the new version, and they find it easier

and more efficient than the original version,

she added.

Most importantly, the technology has made

her IOL selections more accurate, and that

pleases patient and physician alike, Dr. Epitro-

poulos said.

Although the original model still is very

accurate and functional, she said the new ver-

sion offers “definite advantages” to achieving

reliable measurements and increasing effi-

ciency. In a recent study, she found a higher

success rate in measuring axial length in

dense cataracts with the new biometer when

compared with another system (Lenstar LS

900, Haag-Streit), which became available

for clinical use last fall.

“Today, selecting the right IOL to meet in-

dividual patient expectations is more crucial

that ever,” she said. “Patients judge the qual-

ity of surgery by their refractive outcome, and

anything that improves this is a win-win. It is

comforting to know that the [new device] in-

ternally validates these measurements through

its composite technology.”OT

Device receives FDA clearance

Biometer yields quicker measurements

Dr. Epitropoulos

A new biometer (IOLMaster 500, Carl Zeiss

Meditec) to calculate eye measurements

for lens selection related to cataract surgery

has been cleared by the FDA. The device

is twice as fast as previous platforms,

according to the manufacturer.

(Photo courtesy of Carl Zeiss Meditec)

DECEMBER 15, 2010 / Ophthalmology Times6

ophthalmic newsophthalmic news

DECEMBER 15, 2010 / www.ophthalmologytimes.com 7

generalgeneral

The Association for Research in Vision

and Ophthalmology (ARVO) works

closely with the National Alliance for

Eye and Vision Research (NAEVR) to help

ensure that adequate funding is available for

both basic and translational research for the

National Eye Institute (NEI). Translational

research currently is a priority for NEI’s

parent organization, the National Institutes

of Health (NIH). In this column, we outline

recent activities focused on the avenues for

turning research into treatment.

2010 NEI/FDA endpoints symposiumCan measures of structural change correlate

to visual function, then serve as endpoints

in clinical studies to support the approval of

new drug and device diagnostics and thera-

pies for glaucoma?

Finding the answers was the focus of the

2010 NEI/FDA glaucoma clinical trial de-

sign and endpoints symposium, managed by

ARVO, this past September. This meeting,

which was a follow-up to an NEI/FDA glau-

coma symposium held in 2008, brought to-

gether the vision and eye research community

with FDA drug and device approval divisions

to review the latest research that could result

in additional endpoints. Such endpoints could

make glaucoma trials more logistically feasible

by reducing study length, cost, and number of

participants enrolled. The end result will be

that new therapies get to patients sooner.

These symposia demonstrate NEI’s leader-

ship in translational research, as recognized

by NIH Director Francis Collins, MD, PhD,

during NEI’s 40th anniversary celebration

this year.

“The NEI has been central to advances in

translational research,” Dr. Collins said. “Its

vision has allowed us to see farther and better

and has enabled the NIH to attain its vision.

Most importantly, the best is yet to come.”

TMAT Working GroupDr. Collins has identified translational re-

search as one of his top five NIH priorities.

The Translational Medicine and Therapeu-

tics (TMAT) Working Group will lead the

charge to develop a comprehensive transla-

tional research strategy.

The TMAT Working Group held 2 days of

discussions in September with stakeholders

about how the NIH currently coordinates its

numerous initiatives regarding clinical and

translational research—internally and with

other Department of Health and Human

Services (HHS) agencies, such as the FDA;

other government agencies; the private bio-

medical research sector; and the patient and

advocacy community.

Cures Acceleration NetworkRepresentatives from various sectors partici-

pated in a series of panels to address the chal-

lenges NIH faces, with much of the conver-

sation focused on how the NIH would imple-

ment the Cures Acceleration Network (CAN).

Authorized as a new NIH program by

Congress in health-care reform legislation

passed earlier this year, CAN was created to

assist NIH in the rapid translation of basic

research into treatments. Although authoriz-

ing it at $500 million, Congress did not ap-

propriate funding, which is now proposed

at an initial $50 million in draft House and

Senate Fiscal Year 2011 NIH funding bills.

Panelists commented that the exact role

for CAN in accelerating the development of

new therapies (especially drugs) needs to be

determined, and emphasized that translation

not only applies to drug therapies, but to de-

vices as well as gene therapy approaches.

NAEVR speaksNAEVR Executive Director James Jorkasky

provided public comments about NEI’s col-

laborations across the NIH and HHS and with

other government agencies, private funding

organizations, and internationally to “expand

its research dollars smartly and effectively to

develop a rich repertoire of patient solutions.”

ARVO is working closely with NAEVR to

monitor the TMAT Working Group’s devel-

opment of translational research strategy

recommendations not only to determine po-

tential new funding opportunities for vision

researchers, but to ensure continued robust

funding for basic research.OT

Adequate funding

Activities turn research into treatmentAssociations work to ensure support is available for basic and translational research

Take-Home Message

The Association for Research in Vision and

Ophthalmology works closely with the National

Alliance for Eye and Vision Research to help

ensure that adequate funding is available for

both basic and translational research for the

National Eye Institute (NEI). Translational research

currently is a priority for NEI’s parent organization,

the National Institutes of Health. This column

outlines recent activities focused on the avenues

for turning research into treatment.

‘ARVO is working closely with NAEVR to monitor the

TMAT Working Group’s development of translational

research strategy recommendations . . . to determine

potential new funding opportunities.’

Joanne Olson

ARVO View

By Joanne Olson

author infoJoanne Olson is director

of communications, marketing

and sales, for the Association

for Research in Vision and

Ophthalmology. Readers may

contact her at 240/221-2923

or [email protected].

SPECIAL SECTION REFRACTIVE Page 1 CATARACT Page 8

2010

Year in Rev

iew

By Cheryl Guttman Krader

Reviewed by Randall J. Olson, MD,

Robert H. Osher, MD, and Mark Packer, MD

Hindsight being 20/20, 2010 has been

another great year in cataract surgery.

Although there may not have been any

revolutionary product introductions, the year

offered numerous innovations in areas that have

advanced the field and are increasing the ability

of surgeons to deliver better clinical outcomes.

In interviews with Ophthalmology Times, Ran-

dall J. Olson, MD, The John A. Moran Presidential

Professor and chairman, Department of Ophthal-

mology and Visual Sciences, University of Utah,

Salt Lake City; Robert H. Osher, MD, professor

of ophthalmology, University of Cincinnati, OH,

and medical director emeritus, Cincinnati Eye

Institute; and Mark Packer, MD, clinical associ-

ate professor of ophthalmology, Oregon Health &

Science University, Portland, spoke about what’s

new and what’s coming in cataract surgery.

Femtosecond laser surgeryThe approval of a proprietary femtosecond laser

system designed specifically for cataract sur-

gery (LenSx) was the biggest news story in

2009. Originally cleared for use in creating the

anterior capsulotomy, as of mid-November, the

LenSx laser had gained two additional FDA ap-

provals for creating corneal incisions and per-

forming phacofragmentation, and it had been

acquired by Alcon Laboratories.

During 2010, a second cataract surgery fem-

tosecond laser system received FDA clearance

for anterior capsulotomy (LensAR), a third man-

ufacturer’s system is undergoing FDA review

(OptiMedica), and in Europe, Technolas Perfect

Vision has developed a cataract surgery mod-

ule for its femtosecond laser that is being used

in refractive surgery and other applications.

Drs. Olson, Osher, and Packer all are enthu-

siastic about the benefits of femtosecond laser

cataract surgery and note that it should have

a positive impact on greater use of premium

IOLs. However, with cost as a potential barrier,

it remains to be seen how fast and how widely

the technology is adopted into clinical practice.

“The femtosecond laser can guarantee perfect

cataract and astigmatic incisions and a perfect

capsulorhexis, which is going to be increas-

ingly important for achieving good outcomes

with some of the newer IOLs, and it can also

be used to break up rock-hard cataracts into

small, easily aspirated pieces,” Dr. Olson said.

“With these capabilities, it will make cataract

and refractive lens exchange

surgery routinely straight-

forward and safe.

“The biggest question

about femtosecond lasers

is not whether the technol-

ogy offers value but how to

pay for it,” he added.

Dr. Packer also weighed in with comments.

“Considering the thin profit margins for

From devices to drugs

Innovations expand cataract realmAdvances enable surgeons to deliver better clinical outcomes for their patients

Take-Home Message

Hindsight being 20/20, 2010 has been another

great year in cataract surgery. Although there

may not have been any revolutionary product

introductions in 2010, the year offered numerous

innovations in a variety of areas that have

advanced the field and are increasing the ability

of surgeons to deliver better clinical outcomes.

Dr. Olson

See Innovations on page 11

Q-D

Now

Available

The Power of One

The FIRST and ONLY QD ophthalmic NSAID for use in cataract surgery1

INDICATIONS AND USAGE

BROMDAY is a nonsteroidal anti-infl ammatory drug (NSAID) indicated for

the treatment of postoperative infl ammation and reduction of ocular pain in

patients who have undergone cataract extraction.

DOSAGE AND ADMINISTRATION

Instill one drop into the aff ected eye(s) once daily beginning 1 day prior

to surgery, continued on the day of surgery and through the fi rst 14 days

post-surgery.

WARNINGS AND PRECAUTIONS

r�4VMñ�UF�BMMFSHJD�SFBDUJPOT� r�4MPX�PS�EFMBZFE�IFBMJOH

r�1PUFOUJBM�GPS�DSPTT�TFOTJUJWJUZ� r�*ODSFBTF�CMFFEJOH�PG�PDVMBS�UJTTVFT

r�$PSOFBM�Fí�FDUT�JODMVEJOH�LFSBUJUJT� r�$POUBDU�MFOT�XFBS

ADVERSE REACTIONS

The most commonly reported adverse reactions in 2-7% of patients were

abnormal sensation in eye, conjunctival hyperemia and eye irritation

(including burning/stinging).

Rx Only. Please see full prescribing information on adjacent page.

www.istavision.com#30.%":�BOE�4FJ[F�UIF�2�%BZ�BSF�USBEFNBSLT�PG�*45"�1IBSNBDFVUJDBMT �*OD��¥��*45"�1IBSNBDFVUJDBMT �*OD��"MM�SJHIUT�SFTFSWFE��#2%��

Reference1. #30.%":�<QBDLBHF�JOTFSU>��*SWJOF �$"��*45"�1IBSNBDFVUJDBMT �*OD��

http://www.istavision.com

http://www.istavision.com

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the

information needed to use Bromday (bromfenac

ophthalmic solution) 0.09% safely and effectively.

See full prescribing information for Bromday.

Bromday (bromfenac ophthalmic solution) 0.09%

Initial U.S. Approval: 1997

--------------INDICATIONS AND USAGE--------------

Bromday is a nonsteroidal anti-in�ammatory drug

(NSAID) indicated for the treatment of postoperative

in�ammation and reduction of ocular pain in

patients who have undergone cataract extraction (1).

-----------DOSAGE AND ADMINISTRATION-----------

Instill one drop into the affected eye(s) once daily

beginning 1 day prior to surgery, continued on the

day of surgery and through the flrst 14 days post-

surgery (2.1).

---------DOSAGE FORMS AND STRENGTHS---------

Topical ophthalmic solution: bromfenac 0.09% (3)

-----------WARNINGS AND PRECAUTIONS-----------

L�(E<QD5��<<5B793�'513D9?>C��

L�(<?G�?B��5<1I54��51<9>7��

L�%?D5>D91<�6?B�3B?CC�C5>C9D9F9DI��

L��>3B51C5�2<5549>7�?6�?3E<1B�D9CCE5C��

L��?B>51<�56653DC�9>3<E49>7�;5B1D9D9C��

L��?>D13D�!5>C�,51B��

------------------ADVERSE REACTIONS------------------

The most commonly reported adverse reactions in

2-7% of patients were abnormal sensation in eye,

conjunctival hyperemia and eye irritation (including

2EB>9>7CD9>79>7��

To report SUSPECTED ADVERSE REACTIONS,

contact ISTA Pharmaceuticals, Inc. at

1-877-788-2020, or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION

Revised: 9/2010

FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE


is indicated for the treatment of postoperative

in�ammation and reduction of ocular pain in

patients who have undergone cataract surgery.

2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

For the treatment of postoperative in�ammation in

patients who have undergone cataract extraction,

one drop of Bromday ophthalmic solution should be

applied to the affected eye(s) once daily beginning

1 day prior to cataract surgery, continued on the

day of surgery, and through the flrst 14 days of the

postoperative period.

2.2 Use with Other Topical Ophthalmic Medications

Bromday ophthalmic solution may be administered

in conjunction with other topical ophthalmic

=54931D9?>C�CE38�1C�1<@81�17?>9CDC��25D1�2<?3;5BC��

carbonic anhydrase inhibitors, cycloplegics, and

mydriatics. Drops should be administered at least

��=9>ED5C�1@1BD

3. DOSAGE FORMS AND STRENGTHS

Topical ophthalmic solution: bromfenac 0.09%.

4. CONTRAINDICATIONS

None.

5. WARNINGS AND PRECAUTIONS

5.1 Sulflte Allergic Reactions

�?>D19>C�C?49E=�CE<QD5��1�CE<QD5�D81D�=1I�31EC5�

allergic-type reactions including anaphylactic

symptoms and life-threatening or less severe

asthmatic episodes in certain susceptible people.

The overall prevalence of sulflte sensitivity in the

75>5B1<�@?@E<1D9?>�9C�E>;>?G>�1>4�@B?212<I�

low. Sulflte sensitivity is seen more frequently in

asthmatic than in non-asthmatic people.

5.2 Slow or Delayed Healing

All topical nonsteroidal anti-in�ammatory drugs

(NSAIDs) may slow or delay healing. Topical

3?BD93?CD5B?94C�1B5�1<C?�;>?G>�D?�C<?G�?B�45<1I�

851<9>7��?>3?=9D1>D�EC5�?6�D?@931<�#(��C�1>4�

topical steroids may increase the potential for

healing problems.

5.3 Potential for Cross-Sensitivity

There is the potential for cross-sensitivity to

acetylsalicylic acid, phenylacetic acid derivatives,

and other NSAIDs. Therefore, caution should be

used when treating individuals who have previously

exhibited sensitivities to these drugs.

5.4 Increased Bleeding Time

,9D8�C?=5�#(��C��D85B5�5H9CDC�D85�@?D5>D91<�6?B�

increased bleeding time due to interference with

platelet aggregation. There have been reports that

ocularly applied NSAIDs may cause increased

bleeding of ocular tissues (including hyphemas) in

conjunction with ocular surgery.

It is recommended that Bromday ophthalmic

C?<ED9?>�25�EC54�G9D8�31ED9?>�9>�@1D95>DC�G9D8�;>?G>�

bleeding tendencies or who are receiving other

medications which may prolong bleeding time.

5.5 Keratitis and Corneal Reactions

*C5�?6�D?@931<�#(��C�=1I�B5CE<D�9>�;5B1D9D9C�

In some susceptible patients, continued use of

D?@931<�#(��C�=1I�B5CE<D�9>�5@9D85<91<�2B51;4?G>��

corneal thinning, corneal erosion, corneal

ulceration or corneal perforation. These events

=1I�25�C978D�D8B51D5>9>7�%1D95>DC�G9D8�5F945>35�?6�

3?B>51<�5@9D85<91<�2B51;4?G>�C8?E<4�9==5491D5<I�

discontinue use of topical NSAIDs and should be

closely monitored for corneal health.

%?CD�=1B;5D9>7�5H@5B95>35�G9D8�D?@931<�#(��C�

suggests that patients with complicated ocular

surgeries, corneal denervation, corneal epithelial

defects, diabetes mellitus, ocular surface diseases

(e.g., dry eye syndrome), rheumatoid arthritis, or

repeat ocular surgeries within a short period of time

=1I�25�1D�9>3B51C54�B9C;�6?B�3?B>51<�14F5BC5�5F5>DC�

which may become sight threatening. Topical NSAIDs

should be used with caution in these patients.

%?CD�=1B;5D9>7�5H@5B95>35�G9D8�D?@931<�#(��C�

also suggests that use more than 24 hours prior to

surgery or use beyond 14 days post surgery may

9>3B51C5�@1D95>D�B9C;�6?B�D85�?33EBB5>35�1>4�C5F5B9DI�

of corneal adverse events.

5.6 Contact Lens Wear

Bromday should not be administered while wearing

contact lenses

6. ADVERSE REACTIONS

6.1 Clinical Trial Experience

The most commonly reported adverse experiences

reported following use of bromfenac after cataract

surgery include: abnormal sensation in eye,

conjunctival hyperemia, eye irritation (including

burning/stinging), eye pain, eye pruritus, eye

redness, headache, and iritis. These events were

reported in 2-7% of patients.

6.2 Post-Marketing Experience

The following events have been identifled during

@?CD�=1B;5D9>7�EC5�?6�2B?=65>13�?@8D81<=93�

solution 0.09% in clinical practice. Because

they are reported voluntarily from a population

?6�E>;>?G>�C9J5��5CD9=1D5C�?6�6B5AE5>3I�31>>?D�

be made. The events, which have been chosen

for inclusion due to either their seriousness,

frequency of reporting, possible causal connection

to topical bromfenac ophthalmic solution 0.09%

or a combination of these factors, include corneal

erosion, corneal perforation, corneal thinning,

1>4�5@9D85<91<�2B51;4?G>�/C55�,1B>9>7C�1>4�

%B531ED9?>C��0

8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Teratogenic Effects: Pregnancy Category C.

'5@B?4E3D9?>�CDE495C�@5B6?B=54�9>�B1DC�1D�?B1<�

4?C5C�E@�D?��=7;741I��D9=5C�D85�

B53?==5>454�8E=1>�?@8D81<=93�4?C5�/'�$�0��

1>4�9>�B1229DC�1D�?B1<�4?C5C�E@�D?��=7;7

41I��D9=5C�'�$��B5F51<54�>?�5F945>35�

?6�D5B1D?75>939DI�4E5�D?�2B?=65>13��?G5F5B��

=7;741I�9>�B1DC�31EC54�5=2BI?�65D1<�<5D81<9DI��

increased neonatal mortality, and reduced postnatal

7B?GD8�%B57>1>D�B1229DC�DB51D54�G9D8��=7;741I�

caused increased post-implantation loss.

There are no adequate and well-controlled

studies in pregnant women. Because animal

reproduction studies are not always predictive of

human response, this drug should be used during

pregnancy only if the potential beneflt justifles the

@?D5>D91<�B9C;�D?�D85�65DEC

Nonteratogenic Effects:

�531EC5�?6�D85�;>?G>�56653DC�?6�@B?CD17<1>49>�

biosynthesis-inhibiting drugs on the fetal

cardiovascular system (closure of ductus arteriosus),

the use of Bromday ophthalmic solution during late

pregnancy should be avoided.

8.3 Nursing Mothers

�1ED9?>�C8?E<4�25�5H5B39C54�G85>��B?=41I�9C�

administered to a nursing woman.

8.4 Pediatric Use

Safety and efflcacy in pediatric patients below the

age of 18 have not been established.

8.5 Geriatric Use

There is no evidence that the efflcacy or safety

@B?Q<5C�6?B��B?=41I�49665B�9>�@1D95>DC��I51BC�?6�

age and older compared to younger adult patients.

11. DESCRIPTION


is a sterile, topical, nonsteroidal anti in�ammatory

4BE7��#(��6?B�?@8D81<=93�EC5��138�=!�?6�

�B?=41I�3?>D19>C��=7�2B?=65>13�C?49E=�

(equivalent to 0.9 mg bromfenac free acid).

Bromfenac sodium is designated chemically as

C?49E=� �1=9>?��2B?=?25>J?I<��@85>I<135D1D5�

sesquihydrate, with an empirical formula of

��

�11

�B##1$3 B��O�

2$��)85�CDBE3DEB1<�6?B=E<1�6?B�

bromfenac sodium is:

Bromfenac sodium is a yellow to orange crystalline

powder. The molecular weight of bromfenac sodium

is 383.17. Bromday ophthalmic solution is supplied

1C�1�CD5B9<5�1AE5?EC��C?<ED9?>��G9D8�1�@��?6�

8.3. The osmolality of Bromday ophthalmic solution

9C�1@@B?H9=1D5<I��=$C=?<;7

Each mL of Bromday ophthalmic solution contains:

Active:�2B?=65>13�C?49E=�8I4B1D5��

Preservative:��25>J1<;?>9E=�38<?B945��=7=!�

Inactives: boric acid, disodium edetate (0.2 mg/

=!��@?<IC?B21D5��=7=!��@?F94?>5��

=7=!��C?49E=�2?B1D5��C?49E=�CE<QD5�1>8I4B?EC�

� �=7=!��C?49E=�8I4B?H945�D?�14:ECD�@��1>4�

G1D5B�6?B�9>:53D9?>��*(%

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bromfenac is a nonsteroidal anti-in�ammatory drug

(NSAID) that has anti-in�ammatory activity. The

mechanism of its action is thought to be due to its

129<9DI�D?�2<?3;�@B?CD17<1>49>�CI>D85C9C�2I�9>8929D9>7�

cyclooxygenase 1 and 2.

%B?CD17<1>49>C�81F5�255>�C8?G>�9>�=1>I�1>9=1<�

=?45<C�D?�25�=5491D?BC�?6�35BD19>�;9>4C�?6�

intraocular in�ammation. In studies performed in

animal eyes, prostaglandins have been shown to

produce disruption of the blood-aqueous humor

barrier, vasodilation, increased vascular permeability,

<5E;?3ID?C9C��1>4�9>3B51C54�9>DB1?3E<1B�@B5CCEB5

12.3 Pharmacokinetics

The plasma concentration of bromfenac following

ocular administration of 0.09% Bromday (bromfenac

?@8D81<=93�C?<ED9?>��9>�8E=1>C�9C�E>;>?G>��1C54�

on the maximum proposed dose of one drop to

D85�5I5��=7��1>4�% �9>6?B=1D9?>�6B?=�?D85B�

routes of administration, the systemic concentration

of bromfenac is estimated to be below the limit

?6�AE1>D9Q31D9?>��>7=!��1D�CD514I�CD1D5�9>�

humans.

13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and Impairment

of Fertility

!?>7�D5B=�31B39>?75>939DI�CDE495C�9>�B1DC�1>4�=935�

79F5>�?B1<�4?C5C�?6�2B?=65>13�E@�D?��=7;741I�

(900 times the recommended human ophthalmic

4?C5�/'�$�0�?6��=37;7�9>��;7�@5BC?>�?>�

1�=7;721C9C��1CCE=9>7��12C?B254��1>4�

��=7;741I��D9=5C�'�$��B5C@53D9F5<I�

revealed no signiflcant increases in tumor incidence.

Bromfenac did not show mutagenic potential

in various mutagenicity studies, including the

reverse mutation, chromosomal aberration, and

micronucleus tests.

Bromfenac did not impair fertility when administered

orally to male and female rats at doses up to 0.9

=7;741I�1>4��=7;741I��B5C@53D9F5<I��

1>4��D9=5C�'�$��B5C@53D9F5<I�

14. CLINICAL STUDIES

14.1 Ocular in�ammation and pain following

cataract surgery

�<9>931<�56Q313I�G1C�5F1<E1D54�9>�D8B55�B1>4?=9J54��

4?E2<5�=1C;54��@<1352?�3?>DB?<<54�DB91<C�9>�G8938�

subjects requiring cataract surgery were assigned

D?��B?=41I�?B�@<1352?��%1D95>DC�G5B5�4?C54�G9D8�

one drop per eye starting the day before surgery

and continuing for 14 days. The primary endpoint

G1C�3<51B9>7�?6�?3E<1B�9>R1==1D9?>�2I�41I��>�

additional efflcacy endpoint was the number of

patients who were pain free on day 1 after cataract

surgery.

In 2 of the 3 studies, Bromday ophthalmic solution

had statistically signiflcant higher incidence of

3?=@<5D5<I�3<51B9>7�9>R1==1D9?>��FC� ��

29%) and also had a statistically signiflcant higher

incidence of subjects that were pain free at day 1

@?CD�31D1B13D�CEB75BI��FC��

16. HOW SUPPLIED/STORAGE AND HANDLING


9C�CE@@<954�9>�1�G89D5�!�%��@<1CD93�CAE55J5�2?DD<5�

G9D8�1��==�!�%��G89D5�4B?@@5B�D9@�1>4��==�

polypropylene gray cap as follows:

��=!�9>��=!�3?>D19>5B��#��

STORAGE (D?B5�1D��M�K� �M��M�K��M��

17. PATIENT COUNSELING INFORMATION

17.1 Slowed or Delayed Healing

%1D95>DC�C8?E<4�25�14F9C54�?6�D85�@?CC929<9DI�D81D�

slow or delayed healing may occur while using

NSAIDs.

17.2 Sterility of Dropper Tip

%1D95>DC�C8?E<4�25�14F9C54�D?�>?D�D?E38�4B?@@5B�

tip to any surface, as this may contaminate the

contents.

17.3 Concomitant Use of Contact Lenses

�?>D13D�<5>C5C�C8?E<4�>?D�25�G?B>�4EB9>7�D85�EC5�

of this product.

17.4 Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is

being used, the medicines should be administered

1D�<51CD��=9>ED5C�1@1BD

Rx Only

©ISTA Pharmaceuticals®, Inc."1>E613DEB54�6?B��()��%81B=135ED931<C��>3

�BF9>5��

�I��1EC38��!?=2��>3?B@?B1D54

)1=@1��!��

Under license from:(5>:E�%81B=135ED931<C��?��!D4

$C1;1��1@1>�� &��

P�1>4�N�=1B;C�?G>54�2I��()��%81B=135ED931<C��>3

�*!!�%'�(�'��#��#�$'"�)�$#��$#)�#)(�

��#��)�$#(��#��*(��

��$(��#��"�#�()'�)�$#

��'53?==5>454��?C9>7

�*C5�G9D8�$D85B�)?@931<�$@8D81<=93�

Medications

��$(��$'"(��#��()'�#�)�(

��$#)'��#��)�$#(

��,�'#�#�(��#��%'��*)�$#(

��(E<QD5��<<5B793�'513D9?>C

� �(<?G�?B��5<1I54��51<9>7

��%?D5>D91<�6?B��B?CC�(5>C9D9F9DI

��>3B51C54��<5549>7�)9=5

�� 5B1D9D9C�1>4��?B>51<�'513D9?>C

��?>D13D�!5>C�,51B

��+�'(��'��)�$#(

��<9>931<�)B91<��H@5B95>35

� �%?CD�"1B;5D9>7��H@5B95>35

��*(��#�(%��%$%*!�)�$#(

��%B57>1>3I

8.3 Nursing Mothers

��%5491DB93�*C5

��5B91DB93�*C5

��(�'�%)�$#

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SPECIAL SECTION

Year in Review

Dr. Osher

Dr. Packer

See Phaco on page 12

routine cataract surgery, it is probably only

the surgeons doing a high volume of premium

channel IOL procedures who can possibly in-

corporate the femtosecond

laser into their practices,”

Dr. Packer said. “For these

latter surgeons, femtosecond

laser surgery can provide a

competitive marketing ad-

vantage, although the irony is

that lower-volume surgeons

may benefit even more from the ability of the

laser to deliver superior outcomes.”

However, both Dr. Packer and Dr. Osher sug-

gested that market pressure may ultimately

drive wider adoption of the femtosecond laser

despite initial resistance among surgeons who

consider it unnecessary and too expensive.

“In the past, the introduction of phacoemul-

sification and the femtosecond laser for LASIK

flap creation met with the same type of reac-

tions in the ophthalmologist community,” Dr.

Packer said. “However, if femtosecond laser

cataract surgery takes flight, there will be com-

mercial pressure for its wider-spread adoption.”

Dr. Osher offered a similar perspective, sug-

gesting that the situation with the femtosec-

ond laser will evoke older surgeons’ memories

of the past when the introduction of superior

technology was met initially by skepticism and

resistance relating mostly to

financial issues.

“For sure the femtosecond

laser is expensive, but cost

was a major criticism raised

against ophthalmic viscosur-

gical devices (OVDs) and

phacoemulsification when

they were introduced for cataract surgery,” Dr.

Osher said. “However, technology that provides

superior results eventually becomes embraced

by the profession, even though that may be

due in part to fear over losing patients to the

competition.”

He predicted that widespread adoption of

the femtosecond laser will not occur any time

soon, but that it will ultimately become the new

standard of cataract surgery because of its ben-

efits for delivering precise refractive outcomes.

From adoption of the femtosecond laser, there

will be a springboard effect on greater use

of advanced-technology IOLs, Dr. Osher said.

As the femtosecond laser field begins to ma-

ture and surgeons consider which system to use,

they will be looking for distinguishing features.

“As the first platform to receive FDA approval,

LenSx is ahead of the curve right now, lead-

ing the competition with the most approvals,

and Alcon may develop bundling options to

make laser use more financially accessible,”

Dr. Packer said. “Meanwhile, LensAR is try-

ing to capitalize on potential advantages of its

imaging and guidance system and its ability

to phacofragment denser cataracts, an indica-

tion currently under FDA review.”

The LensAR femtosecond laser also is being

developed for use in a lentotomy procedure for

correcting presbyopia. A clinical trial investi-

gating that technique, which was pioneered

by Ron Krueger, MD, Cleveland, OH, was just

launched outside of the United States. Both Dr.

Packer and Dr. Olson believe treatment of pres-

byopia may be the most appealing potential

capability of the femtosecond laser.

Ultrasound platformsDr. Olson mentioned that findings from a survey

completed at the end of 2009 showed an over-

whelming acceptance of “horizontal” (i.e., tor-

sional or transversal) ultrasound among cataract

surgeons. Manufacturers of phacoemulsification

units featuring these modalities are continuing

to add innovations to enhance their platforms.

Torsional ultrasound using the OZil hand-

piece and Infiniti Vision System (Alcon Labo-

ratories) continues to be a leader in the mar-

ket, and its performance has been enhanced by

the introduction of OZil Intelligent Phaco (OZil

IP) , an innovative software solution to prevent

tip occlusion and maximize the shearing per-

formance of torsional ultrasound. To use OZil

IP, the surgeon sets a vacuum threshold that is

lower than the vacuum limit and parameters

for longitudinal ultrasound. When the software

senses the vacuum is reaching the threshold

value, a burst of longitudinal ultrasound is au-

tomatically introduced, clearing the tip.

Dr. Osher noted he has found OZil IP to be

very useful in his own practice and observed

it continues to gain momentum in the over-

all market.

“OZil IP improves chamber stability and

has enhanced the efficiency of torsional ul-

trasound, which was already a great step for-

ward in phacoemulsification,” he said.

Transversal ultrasound, which blends hor-

izontal and longitudinal tip motions, is per-

formed using the WhiteStar Signature (Abbott

Medical Optics [AMO]), and in 2010, the tech-

nology was upgraded with the introduction of

Ellips FX. Compared with the original Ellips

ultrasound, Ellips FX offers higher-frequency

cutting performance and a larger zone of tis-

sue removal, according to the manufacturer.

AMO also introduced a wireless foot switch

for the WhiteStar Signature platform this year.

Transversal ultrasound is newer technol-

ogy and has less of a market share than tor-

sional ultrasound, but it has several benefits,

Dr. Olson said.

“The potential for tip clogging is minimized

with Ellips FX because it incorporates longi-

tudinal motion, and in a study we conducted,

Ellips FX proved to be the best technology for

eliminating rock-hard cataracts,” he explained.

Dr. Packer noted that he enjoys similarly ex-

quisite safety, chamber stability, and efficiency

in consuming lens material whether using tor-

sional or transversal ultrasound. However, he

finds the increased flexibility afforded by the

WhiteStar Signature platform in terms of the

opportunity to use either a true Venturi or a true

peristaltic pump represents a slight advantage.

“Most surgeons today use a peristaltic pump

anyway, but I have gone to using the Venturi

system except in cases of small pupil or floppy

iris,” he explained.

“I use a chop setting to cut the nucleus and

the Venturi segmentation or aspiration setting

to pull the nuclear pieces in, and I have found

this very fast and efficient to the point where

its performance maybe even exceeds torsional

ultrasound with the Infiniti,” he said.

The Stellaris Vision Enhancement System

(Bausch + Lomb) also has a dual-pump sys-

tem with a Venturi pump and a peristaltic em-

ulation system. Used together with the inline

filter to reduce surge, the Stellaris is also very

efficient, although in Dr. Packer’s experience,

the WhiteStar Signature offers better cham-

ber stability.

“All three of these platforms are excellent

and can be used reliably to perform atraumatic

phaco and achieve clear corneas on postop

day 1, which for me is the bottom line,” Dr.

Packer said. “Which system is better is a mat-

ter of personal preference, but it’s nice to have

InnovationsContinued from page 8

Figure 1 A phaco software upgrade

(OZil Intelligent Phaco, Alcon Laboratories)

further enhances safety, efficiency, and

control for surgeons performing torsional

ultrasound with a proprietary handpiece

and phaco system (OZil and Infiniti Vision

System, Alcon). (Photo courtesy of Alcon Laboratories)

12 DECEMBER 15, 2010 / Ophthalmology Times

Year in Review

SPECIAL SECTION

a variety of good choices so surgeons can see

which best fits their style and level of devel-

opment in performing phaco.

“Although I’ve been doing phacoemulsifi-

cation for 15 years, I am still learning and my

technique is still evolving, and I try new mo-

dalities as they become available to see how

they match my comfort level and technique,”

Dr. Packer said.

A new digital, pressurized infusion system

(DigiFlow) is the latest enhancement to the

Stellaris Vision Enhancement System, and that

platform continues to be distinguished from

the competition by enabling microcoaxial sur-

gery to be performed safely through the small-

est incision. With its 1.8-mm MICS technique,

Bausch + Lomb has cracked the 2.0-mm inci-

sion threshold, noted Dr. Osher.

“The smaller incision size is not just a mar-

keting tactic, it is a trend that cannot be ar-

rested,” Dr. Osher said. “Realizing the poten-

tial of refractive cataract surgery means avoid-

ing surgically induced astigmatism, and so we

can expect to see incision size continue to de-

crease. However, a smaller-incision technique

will only be acceptable if it does not compro-

mise fluidics, chamber stability, IOL quality,

and incision integrity.”

IOLs

Dr. Packer rated the European release of the Acry-

Sof IQ ReSTOR Toric IOL (Alcon Laboratories)

as the biggest IOL news of the year considering

that the lack of a toric version of any multifo-

cal IOL in the United States has been a major

barrier to the greater use of this technology.

“More clinical data are needed on outcomes

with the new toric multifocal lens, but recog-

nizing that my LASIK enhancement rate for pa-

tients having limbal relaxing incisions (LRIs)

has been about 18% and mostly involves [pa-

tients with] multifocal IOLs, having a toric mul-

tifocal option is a big step forward,” he said.

He added that the growing use of toric IOLs

gives credence to the idea that surgeons are

more comfortable using a toric IOL than an in-

cisional technique to correct astigmatism. With

many surgeons limiting their use of multifo-

cal IOLs to patients with less than 1 D of pre-

existing corneal astigmatism, the toric model

will expand the pool of potential candidates,

said Dr. Packer.

Dr. Osher is also excited about the upcoming

availability of the AcrySof multifocal toric IOL

and noted U.S. surgeons can look forward in

the future to the introduction of new toric IOLs

from AMO, Bausch + Lomb, and Hoya. Alcon

will continue to expand the range for higher

corrections with its toric IOLs; in Europe, the

AcrySof Toric IOL is available in four additional

models that correct between 2.57 and 4.11 D

of cylinder at the corneal plane. Outside the

United States, surgeons have access to other

toric IOLs as well from Rayner, Zeiss, Oculen-

tis, and Dr. Schmidt/HumanOptics, including

multifocal/bifocal and sulcus piggyback ver-

sions, depending on the manufacturer.

Overall, uptake of premium IOLs has been

slow. Currently, this technology represents only

about 13% to 15% of the pseudophakic im-

plant market. The most recent introductions

offer attractive features, but it seems it will

take an “even better mousetrap” to jump start

greater growth in premium IOL implantations,

observed Dr. Olson.

AcrySof IQ ReSTOR (Alcon) occupies a sig-

nificant share of the multifocal IOL market in

the United States, and its intermediate vision

performance was enhanced with the introduc-

tion of the +3.0 D add version. As a newer

entry, the Tecnis multifocal IOL (AMO) has

been well received and offers an advantage of

providing good reading vision in low light con-

ditions, although glare is probably more of an

issue with the Tecnis multifocal lens than with

the AcrySof ReSTOR +3.0 D, said Dr. Olson.

He added that the Crystalens HD accommo-

dating IOL (Bausch + Lomb) gives some re-

fractive plus and got off to a good start when

it was first introduced. However, the number

of implantations has been slowed by some re-

ports about peripheral distortions.

In January, Bausch + Lomb announced the

launch of the first aberration-free accommodat-

ing IOL with aspheric optics (Crystalens AO)

to cataract surgeons worldwide. The lens has

prolate aspheric surfaces and is designed to

be free of spherical aberration. The IOL is de-

signed to improve retinal image quality with-

out compromising depth of field and, therefore,

it provides greater quality of distance and in-

termediate vision, according to the company.

The dual-accommodating IOL (Synchrony,

AMO) remains under FDA review. Looking at

accommodating IOLs that are in earlier stages

of development, Dr. Olson said the Fluid Vision

accommodating IOL (PowerVision) and Nu-

Lens accommodating IOL (NuLens) are very

exciting because of their high accommoda-

tive range, and development of the NuLens

has progressed into the first implantation in

seeing patients.

The Light Adjustable Lens (Calhoun Vision)

is currently in a phase III trial in the United

States. Dr. Olson noted that some well-known

European surgeons who reported their experi-

ence at the 2010 annual meeting of the European

Society of Cataract and Refractive Surgeons

(ESCRS) were enthusiastic about their results.

“Not only have they been able to adjust cyl-

inder and sphere, but also spherical aberra-

tion,” Dr. Olson said. “According to some, one

adjustment protocol that induces a little bit of

hyperasphericity seems to create a nearly ideal

presbyopia-correcting IOL that provides excel-

lent near and distance vision without the visual

symptoms associated with multifocal IOLs.”

Drs. Osher and Packer both mentioned the

availability of the Rayner sulcus piggyback

IOLs (Sulcoflex) as an advantage enjoyed by

surgeons outside of the United States. This im-

plant technology is available in three versions

for correcting residual sphere, cylinder, or pres-

byopia. Sulcus piggyback IOLs are also avail-

able in Europe from Dr. Schmidt/HumanOptics.

“The sulcus piggyback IOL is a great option to

offer to patients even years after their primary

surgery, who perhaps may have developed in-

creased astigmatism or become tired of their

dependence on glasses, because it involves a

technique that is more familiar to cataract sur-

geons than LASIK and uses a lens specifically

designed for sulcus placement,” Dr. Packer said.

He added that the lack of any sulcus-spe-

cific IOLs in the United States also is a problem

pertaining to the management of complicated

cases where capsular placement is not an op-

tion and surgeons are sometimes using lenses

that are totally inappropriate for sulcus fixation.

Other developments in the IOL marketplace

include continuation of the trend for more

power options both with extended ranges of

sphere and smaller steps for some lenses. In

2009, the Crystalens became available in 0.25

D steps, and in 2010, Lenstec introduced the

PhacoContinued from page 11

‘The smaller incision

size is not just a

marketing tactic,

it is a trend that

cannot be arrested.’

Robert H. Osher, MD


SPECIAL SECTION

Year in Review

Softec HD, which is available in 0.25-D

increments across the +18 to +25 D

power range.

The smaller power increments are

meeting the growing interest in achiev-

ing increasing precision in power se-

lection. This movement is being fueled

by the ability to achieve more predict-

able refractive outcomes, thanks now

to the availability of better biometry

and in the future with the implemen-

tation of femtosecond laser cataract

surgery, according to Dr. Osher.

“Eventually we will see even more

customization in IOLs and not just for

sphere and cylinder, but even incor-

porating higher-order optical aberra-

tions,” he predicted.

Intraoperative guidance toolsIntraoperative wavefront aberrometry

(ORange Intraoperative Wavefront Ab-

errometer, WaveTec Vision) was in-

troduced in 2009, and based on his

experience and reported results from

other surgeons, Dr. Packer has grow-

ing confidence in the value of this

technology for improving refractive

outcomes of cataract surgery. In a re-

cently published paper, he reported

use of intraoperative wavefront ab-

errometry reduced the enhancement

rate among patients undergoing LRIs

for astigmatic correction. He expects

to see evidence documenting its ad-

vantage for improving the accuracy of

toric IOL positioning, and he added he

is beginning to see a real advantage

using the device to guide IOL power

selection in postLASIK eyes.

“For aphakic IOL power selection,

intraoperative wavefront aberrometry

does not give a perfect result every

time, especially in patients who had

higher amounts of correction in their

refractive surgery procedure, and it

should not be relied on as the ultimate

answer,” Dr. Packer said. “However,

since I have been using the second

generation of the system, it seems to

provide valuable additional informa-

tion that I can integrate to improve the

chances of getting a good outcome.”

Dr. Packer’s approach is first to run

all the formulas on the American So-

ciety of Cataract and Refractive Sur-

gery (ASCRS) Web site for postLA-

SIK IOL power calculations. Then he

compares those results, which can

represent a fairly wide range, against

the value derived from intraoperative

wavefront measurement. Using a re-

cent patient as an example, he said

the preoperative power calculations

identified IOL powers between +18

and +22 D while the intraoperative

wavefront measurement determined

the power should be +17.5 D.

“I picked +18.0 D and the patient

[saw] 20/30+ right after surgery and

20/25 on the first day postop,” Dr. Packer

said. “I’ve achieved similar outcomes

in several other patients, and so my

level of confidence for using this tech-

nology in the aphakic power calcula-

tion for postLASIK eyes is growing.”

He mentioned that Dan Tran, MD,

has accumulated a reasonably large

series of patients with good results as

well, and while more data are needed,

it is beginning to look like intraopera-

tive wavefront aberrometry is reaching

a point where surgeons should per-

haps seriously consider it for improv-

ing refractive outcomes in patients un-

dergoing postLASIK cataract surgery.

However, Dr. Olson and Dr. Osher

are more skeptical about the value of

intraoperative aberrometry with this

platform. Dr. Olson questions how well

the intraoperative measurement cor-

relates with the postoperative result,

taking into account that the eye is not

in its natural and final state during

surgery. Speculum placement can in-

duce regular and irregular astigma-

tism, lens position can take up to 1

week to stabilize, and the intraocular

See Accuracy on page 14

measurement does not allow for

any change in refraction that

can occur from wound-related

effects, he observed.

Still, Dr. Olson remains open-

minded and optimistic and is

planning a study of his own to

investigate the potential of the

technology for improving refrac-

tive outcome accuracy.

Dr. Osher’s doubts relate to

the fact that the WaveTec system

is based on static, Talbot-Moire

‘The sulcus

piggyback IOL is

a great option . . .

to patients even

years after their

primary surgery.’

Mark Packer, MD

http://www.rumex.net


Year in Review

SPECIAL SECTION

inferometery. He is more enthusiastic about

a dynamic real-time intraoperative wavefront

scanning system (Holos, Clarity Medical Sys-

tems) that he thinks holds greater promise as a

solution for confirming emmetropia and toricity

because it allows continuous measurements.

As the pioneer who introduced intraopera-

tive astigmatic keratomy in the 1980s, Dr. Osher

has been a leading proponent of innovations for

correcting pre-existing astigmatism in patients

undergoing cataract surgery. With use of toric

IOLs instead of an incisional technique, cor-

rection of pre-existing cylinder has become a

science, not an art, but he emphasized achiev-

ing consistently precise outcomes with toric

IOLs will depend on additional innovations

for identifying the target axis beyond the use

of $1 marking pens.

“There is now some very exciting technology

available that we will see refined and perfected

in the next few years,” he said. “Whereas safety

and efficacy were the key words for discussing

cataract surgery outcomes in the past, accuracy

and precision will be the focus of the future.”

Other options for guiding orientation of toric

IOLs include software based on Dr. Osher’s method

of “iris fingerprinting,” which is now available

from Micron Imaging and Haag- Streit. This ap-

proach is based on the concept that unique

landmarks in iris tissue can be used as a guide

for accurately marking the eye intraoperatively.

The software creates overlaying reference lines

on a high-magnification iris image obtained at

the slit-lamp during the routine preop exam.

He mentioned excellent iris registration soft-

ware is also available from Carl Zeiss Meditec

(Zeiss Toric Solution) and SensoMotoric Instru-

ments (Integrated Visual Guidance). In addi-

tion, a virtual guidance template for assisting

toric IOL alignment will be available in the

future for the TrueWare 7.0 3-D Visualization

and Guidance Platform (TrueVision Systems).

Currently, the TrueWare system has guid-

ance templates for LRIs and capsulorhexis cre-

ation that are generated from preoperative im-

ages, and it was recently enhanced with the

introduction of a flat-panel monitor and faster

processor, said Dr. Packer, who has been in-

volved in the development of this technology.

The guidance templates for the TrueWare

platform appear as an overlay on the operative

display of the eye and move in concert with

the image of the eye as it moves.

“Unlike intraoperative wavefront aberrom-

etry, this system does not provide real-time

feedback on the outcome, but it is likely supe-

rior to ink markings for achieving predictable

results,” Dr. Packer said.

He added that he is using the 3-D system rou-

tinely in one operating room and is enjoying

both its ergonomic and educational advantages.

“Visitors love it because they can see ex-

actly what I am seeing and without the loss

of depth that occurs when looking through

an assistant’s microscope,” Dr. Packer said.

Dr. Osher also considers the TrueWare 3-D

system a tremendous asset as an educational

tool, noting he has been using it for the past 9

months when teaching at various conferences

around the country.

He added that while TrueVision currently is

a leader in 3-D technology, the field is expand-

ing. Sony introduced a 3-D system at the AAO

meeting and GET3-DDISPLAY has introduced

a 3-D monitor developed by a German-Hun-

garian company that displays a beautiful 3-D

image without any need for special glasses.

Cleared by the FDA in October 2009, opti-

cal low-coherence reflectometry (Lenstar LS,

Haag- Streit) has established itself in 2010 as

a formidable competitor to partial coherence

interferometry (IOLMaster, Carl Zeiss Meditec)

for optical biometry. The new instrument pro-

vides accurate axial length and keratometry

measurements and matches the IOLMaster

in terms of efficiency, cost-effectiveness, and

patient-friendliness, according to Dr. Packer.

“For surgeons who already have an IOL-

Master with the latest software, there seems

no reason to switch, but for those looking to

make a new purchase, Lenstar is another op-

tion that gives all of the same information plus

more,” he noted.

The “more” includes data on lens thickness,

and that may turn out to be an important asset

in the future because there is indication lens

thickness will be included in the power calcu-

lation formula for the dual-accommodating IOL

(Synchrony).

Dr. Osher also remarked that the Lenstar 900

is a tremendous addition for cataract surgeons

considering that it provides accurate and re-

liable axial length and keratometry readings

along with seven other measurements “in one

fell swoop.” He noted that in November, Carl

Zeiss Meditec received clearance to market its

IOLMaster 500, which offers faster speed, the

ability to measure keratometry and axial length

simultaneously, composite signal filters, and

user-interface advances.

Also in the area of diagnostics, the iTrace

(Tracey Technologies) is a very exciting platform

for cataract surgeons because of its ability to de-

termine the origin of astigmatism, said Dr. Osher.

“To the best of my knowledge, this is the first

device that separates lenticular and corneal astig-

matism, and that is an important function for

identifying true toric IOL candidates,” Dr. Osher

said. “There are some patients referred for a toric

IOL whose astigmatism turns out to be in their

crystalline lens and others whose corneal astig-

matism has never been recognized because it is

neutralized by astigmatism in the lens.”

Endophthalmitis prophylaxisIn the United States, topical treatment with

a fourth-generation fluoroquinolone con-

tinues to be the most common approach to

using an antibiotic for postcataract surgery

en doph thal mitis prophylaxis, and in 2010, a

new higher-concentration formulation of gati-

floxacin—gatifloxacin 0.5% (Zymaxid, Aller-

gan)—became commercially available with

an approved indication for the treatment of

bacterial conjunctivitis.

Dr. Olson pointed out that each drop of gati-

floxacin 0.5% should deliver a peak concentra-

tion at the target tissue that is about two-thirds

higher than that achieved using the 0.3% for-

mulation and an even greater increase in the

area under the concentration-time curve (AUC),

which has implications for the pharmacody-

namic activity of gatifloxacin and in theory

for improving clinical efficacy.

Dr. Packer said that in the fluoroquinolone

wars that mostly pitted moxifloxacin against

gatifloxacin, one point that clearly emerged was

that moxifloxacin 0.5% (Vigamox, Alcon) deliv-

ered a higher concentration of medication into

the anterior chamber than gatifloxacin 0.3%

(Zymar, Allergan).This difference had some

detrimental implications for gatifloxacin, but

AccuracyContinued from page 13

Figure 2 Gatifloxacin 0.5% (Zymaxid,

Allergan) is a higher concentration

of gatifloxacin. (Photo courtesy of Allergan)


SPECIAL SECTION

Year in Review

is eliminated now with the 0.5% formulation

of gatifloxacin, he noted.

However, as mentioned by Dr. Osher, Alcon

will be introducing a new formulation of moxi-

floxacin featuring a new vehicle that increases

intraocular penetration of the active ingredient.

Dr. Olson noted that while manufacturers

continue to “duke it out” over the superiority

of their respective products, both gatifloxacin

and moxifloxacin seem to have stood the test

of time as choices for off-label en doph thal mitis

prophylaxis. However, while in vitro evidence

suggests besifloxacin (Besivance, Bausch +

Lomb) has better and broader activity against

some potential en doph thal mitis pathogens, par-

ticularly methicillin-resistant Staphylococcus

epidermidis and methicillin-resistant Staphy-

lococcus aureus (MRSA), results from a few

recent studies raise concerns about the safety

and efficacy of the commercially available besi-

floxacin product for use in en doph thal mitis

prophylaxis. The issues are related to the pres-

ence of Durasite in the formulation.

Dr. Olson observed that the use of Durasite

is a benefit for providing sustained antimicro-

bial levels in the tear film. However, by helping

to retain the administered drop on the ocular

surface, Durasite may reduce the amount of an-

tibiotic that penetrates into the anterior cham-

ber [J Cataract Refract Surg. 2010;36:1499-1502].

At the same time, the prolonged retention of

Durasite in the tear film may be a safety con-

cern because there is increased potential for

the product to enter the eye if there is a leaking

incision, and Durasite is very toxic in the ante-

rior chamber [Am J Ophthalmol. 2010;150:498-

504], he explained.

A recent study conducted by Dr. Olson and

colleagues underscores the need to find a safe

and effective alternative to the currently avail-

able fluoroquinolones for use in en doph thal-

mitis prophylaxis. The study he referred to

submitted specimens from the non-operated

eye of patients undergoing cataract surgery

to microbiological evaluation and found 60%

were positive for MRSA in his area [Clin Oph-

thalmol. in press].

“These are community-acquired strains, not

from a population of health-care workers, and

the rate of positivity increased with increasing

patient age,” he said.

Although intracameral cefuroxime has be-

come a frequently used approach for en doph-

thal mitis prophylaxis among European cata-

ract surgeons based primarily on the results

of the randomized, controlled ESCRS study,

criticisms about the study design and lack of

a commercially available intracameral antibi-

otic formulation has limited adoption of this

technique in the United States, according to

Dr. Packer.

Dr. Osher has studied intracameral moxi-

floxacin and was very enthusiastic about it.

However, he noted that hurdles to its adoption

are regulatory in nature because intracameral

use of the topical ophthalmic solution is off-

label while the patient sample size needed for

a pivotal trial to establish efficacy in en doph-

thal mitis prophylaxis and achieve FDA approval

makes the research cost-prohibitive.

Both Dr. Packer and Dr. Olson pointed out

that despite evidence from various studies sup-

porting use of intracameral cefuroxime, from

a theoretical perspective, while its efficacy as

the sole anti-infective modality for en doph thal-

mitis prophylaxis is excellent, the effect is very

short-lived so that topical coverage can greatly

prolong the duration of antibacterial coverage.

“A single intracameral dose of cefuroxime

given at the end of surgery greatly diminishes

from the anterior chamber within a few hours

and is largely gone within 24 hours, whereas we

know from data reported by Dr. Olson that the

period of highest risk for postoperative en doph-

thal mitis extends to 9 days,” noted Dr. Packer

Anti-inflammatory agentsIn October, the FDA cleared bromfenac 0.09%

( Bromday, ISTA Pharmaceuticals) as a once-a-

day non ster oidal anti-inflammatory agent for

controlling inflammation and pain after cat-

aract surgery. Both Dr. Osher and Dr. Packer

considered this an important development be-

cause of its implications for improving medi-

cation compliance.

Dr. Packer was an investigator for the once-a-

day bromfenac 0.09% study and found the single

daily dose was effective in treating and alleviat-

ing postcataract surgery inflammation and pain.

“Part of the reason why less-frequent treat-

ment is adequate may be that contemporary

surgery is so atraumatic that there is less post-

operative inflammation,” Dr. Packer said. “Nev-

ertheless, the opportunity for a simpler postop-

erative medication regimen is a huge advance.”

However, Dr. Olson noted that for his patients

undergoing cataract surgery, he is still dosing

bromfenac 0.09% twice daily as well as using

Zymaxid 0.5% four times daily while he waits

for more data to prove patient outcomes are not

compromised by less-frequent dosing schedules.

Dr. Packer added that he is also using di flu-

pred nate 0.05% emulsion (Durezol, Alcon) just

once daily after cataract surgery. Although first

approved in 2008 for treating inflammation

and pain after cataract surgery, use of di flu-

pred nate has increased significantly this year.

The broader adoption reflects in part the prod-

uct’s acquisition by Alcon in 2010, which gave

it greater name recognition, but is warranted

considering that this potent cor ti co ster oid pro-

vides greater anti-inflammatory activity with a

simpler dosing schedule than previously avail-

able medications in this class, said Dr. Osher.

Surgical toolsIncision sealants that will guarantee incision

closure without the need for suturing or stromal

hydration represents another area of develop-

ment in cataract surgery, and two such prod-

ucts have CE approval, I-Zip (Ocular Therapeu-

tix) and OcuSeal (Beaver-Visitec International).

A recently published study from Dr. Olson

and colleagues investigating OcuSeal in ca-

daver eyes documented that it significantly

improved wound strength [J Cataract Refract

Surg. 2010;36:1775-1778]. Dr. Olson noted in-

cision sealants may take on an increasingly

important role in the future considering that

some investigational accommodating lenses,

including the Synchrony, NuLens, and FluidVi-

sion IOLs, will need to be implanted through

a relatively large incision (3.8 mm and above).

Dr. Osher mentioned that a new viscoan-

esthetic surgical device combining an OVD

with lidocaine (Visthesia, Carl Zeiss Meditec)

is getting positive reviews from European sur-

geons. However, in the United States the only

OVD news is the introduction by AMO of a

See Surgery on page 16

Figure 3 Bromfenac 0.09% (Bromday,

ISTA Pharmaceuticals) is the same

formulation of bromfenac as Xibrom,

marketed in the United States since 2005 for

twice-daily use in treating inflammation and

pain after cataract surgery, but the product

received a once-daily indication based on

evidence of its efficacy in two pivotal trials.

(Photo courtesy of ISTA Pharmaceuticals)


Year in Review

SPECIAL SECTION

SurgeryContinued from page 15

combined Healon/Healon 5 product (Healon

and Healon 5 Dual Pack).

He also highlighted a number of new devices

and techniques that are helping to make cataract

surgery easier and safer. Topping his list is a

new series of soft I/A tips from Bausch + Lomb.

“In the history of my entire career, I believe

Alcon’s introduction of capsule-friendly tips for

I/A has improved the safety of cataract sur-

gery as much as any other development, and

I strongly recommend all surgeons to be using

either a silicone or soft polymer tip for the pur-

pose of capsule protection,” Dr. Osher said.

He also mentioned a technique for IOL ex-

plantation developed by Arup Bhaumik, MD,

India, that was depicted in the grand prize

video in the 2010 ASCRS Film Festival. Dr.

Bhaumik uses a wire snare to surround the

optic, and as he withdraws it via a Monarch

cartridge (Alcon), the IOL refolds, essentially

being removed the same way it was put in.

Dr. Osher also highlighted an expanding

barrier glide that acts as a synthetic poste-

rior capsule. The device is the idea of Anita

Nevyas-Wallace, MD, Bala Cynwyd, PA, and

it is being developed by Varitronics Inc. The

glide can be introduced through a 2.75-mm

phaco incision and expanded in the eye to a

6.25-mm spatula.

Outside the United States, the field of pros-

thetic iris devices continues to evolve and im-

prove. New in this area are customized, fold-

able devices from Dr. Schmidt that are also

available in a selection of colors.

Dr. Osher also mentioned exciting research

is ongoing to reduce the problem of posterior

capsule opacification. Findings from studies

of a neodymium:YAG laser photolysis system

(ARC) designed to remove lens epithelial cells

and proteoglycan attachment molecules are

encouraging, he said.

Cataract surgeons can look forward to the

introduction of the AcrySert C preloaded injec-

tor that can deliver an IOL through a 2.2-mm

incision, and Dr. Osher also mentioned the pio-

neering efforts of Hoya Surgical in introducing a

preloaded IOL system (iSert). These options have

important benefits for protecting against IOL

contamination and iatrogenic damage, he said.

Other new instruments that cataract surgeons

might found particularly useful include a por-

table magnifier (Storz) that will help facilitate

tasks such as tip alignment or IOL loading, a

new double-loop capsule retractor (Microsurgical

Technology), a new manipulator for placing the

Malyugin modified ring (Microsurgical Technol-

ogy), and a series of interchangeable microforceps

and scissors (Crestpoint Management/Geuder).

EducationIn addition to 3-D visualization systems, other

innovations that are advancing education in-

clude surgical simulators, EYESI Surgical Simu-

lator (VR Magic), and Kitaro (developed by Jan-

suke Akura, MD, Japan), as well as the Luma

software series (Eyemaginations) for patient

education, said Dr. Osher.

However, while medical education is bene-

fiting from these developments in technology,

Dr. Osher said it is being hindered by what he

calls the “CME Gestapo.”

Rebelling against the unreasonableness of

some of the new guidelines, Dr. Osher is or-

ganizing a course entitled “Cataract Surgery:

Telling It Like It Is!” to be held in Sarasota, FL,

Jan. 20 to 23, 2011.

“How can ophthalmologists be effectively

educated about what’s new in cataract surgery

when we are prohibited from mentioning prod-

uct names? It’s time to kick back when the tail

starts wagging the dog,” he said.

Practice management considerationsThe disappearance of cataract surgery medi-

cation kits supplied by pharmaceutical com-

panies has had an impact on medication use.

Dr. Packer noted he and his partners follow

a “best available” approach. Aiming to mini-

mize patient costs, they provide free samples

or prescribe medications for which the manu-

facturer has provided discount coupons when

these options are available.

“Cataract surgery medications can be very

expensive for patients who are paying out of

pocket, and if the patient has already opted out

of a refractive lens product because of financial

reasons, they can be really upset by getting a

huge bill at the pharmacy. Minimizing costs is

an important part of our attempt to maximize

patient satisfaction,” Dr. Packer said.

He also noted that ophthalmologists contin-

ued to feel the effects of the economic crisis and

uncertainties about the impact of health-care

reform. Workplace issues exist already and will

escalate as the population need for ophthalmic

services grows and must be met by a physician

workforce that is not expected to increase in

size and will likely even be reduced consider-

ing that many new physicians entering prac-

tice are seeking a 9 to 5 employment situation.

More and more, ophthalmologists are de-

pending on the skills of optometrists and/or

a variety of physician extenders who can as-

sume responsibility for certain tasks and thereby

allow ophthalmologists to concentrate more on

the high-level decision making that requires

their unique expertise, observed Dr. Packer.

“We will need to develop strategies so that

we can continue to provide excellent outcomes

and achieve satisfied patients,” Dr. Packer said.

“In fact, while some may see the introduction

of the femtosecond laser as technology that will

erode the importance of our surgical skills, I

see it as a gained opportunity that will enable

me to spend more on what I alone am quali-

fied to do because of my unique knowledge

and training.”OT

fyiRandall J. Olson, MDE-mail: [email protected]

Dr. Olson is a consultant to and receives lecture fees

from Abbott Medical Optics and Allergan. He is a

consultant to BD Ophthalmic Systems and an equity

owner in Calhoun Vision.

Robert H. Osher, MDE-mail: [email protected]

Dr. Osher is a consultant to Abbott Medical Optics,

Alcon Laboratories, Bausch + Lomb Surgical, Beaver-

Visitec International, Carl Zeiss Meditec, Clarity Medical,

TrueVision, SensoMotoric Instruments, and Haag-

Streit. He does not accept royalties on products and

instruments he has designed.

Mark Packer, MDE-mail: [email protected]

Dr. Packer is a consultant to and/or holds *stock

options in the following companies: Abbott Medical

Optics Inc., Advanced Vision Science Inc., Bausch +

Lomb Surgical Inc., Carl Zeiss Surgical Inc., Celgene

Inc., Corinthian Ophthalmic Inc.*, GE Healthcare, Haag-

Streit USA, ISTA Pharmaceuticals, LensAR Inc.*, Rayner

Intraocular Lenses Ltd., Surgiview LLC*, Transcend

Medical Inc.*, TrueVision Systems Inc.*, and WaveTec

Vision Systems*.

‘[The femtosecond]

will make cataract and

refractive lens exchange

surgery routinely

straightforward.’

Randall J. Olson, MD

Perfect surgeryContinued from page 1

SPECIAL SECTION

Year in Review

them too low, but rather too high, just a little

too high,’ ” quoted Dr. Koch, Professor and The

Allen, Mosbacher, and Law Chair in Ophthal-

mology, Cullen Eye Institute,

Baylor College of Medicine,

Houston.

“As we embark on the road

to the next 10 years to do

great things for our patients

and our profession, let us aim

just a little too high,” he said.

Dr. Koch discussed the quest for the perfect

cataract operation by presenting an “incom-

plete” list of predictions for the next decade.

■ Femtosecond lasers will become fully integrated

into routine clinical practice and will open new doors

into what is achievable. However, the availability

of this technology is raising new questions and

is surrounded by many issues yet to be resolved.

“For example, with the femtosecond laser

surgeons can create a perfect capsulorhexis

every time, but we really don’t know what that

should be,” he said. “It is also to be determined

whether surgeons can afford the extra time,

cost, and [staff] needed initially to implement

the new technology, how it will influence the

role of technicians in surgery, and how will

surgeons be able to provide the femtosecond

laser procedures widely to their patients.”

■ As options for presbyopic correction continue

to proliferate, presbyopic correction will become the

norm in cataract and refractive procedures. Lentic-

ular approaches have advanced and continue

to be “tweaked” by manufacturers to provide

better quality and more effective vision for

patients. In addition, corneal approaches are

emerging with the development of laser vi-

sion correction and corneal inlay procedures.

■ Surgeons will be offering a sequential series of

multiple procedures to patients as they try to pre-

serve and maintain vision over an individual’s life-

time. Dr. Koch offered this proposal as a corol-

lary to the burgeoning of options for presbyopic

correction. He envisioned a situation where a

25-year-old might undergo LASIK for refrac-

tive correction, have PRK enhancement at 34

years of age, receive an intracorneal inlay at

age 46 to address presbyopia, eventually have

the inlay removed to undergo crystalline lens

extraction with implantation of an accommo-

dating IOL, and then perhaps have a wavefront

adjustment performed a decade later.

■ Achieving the goal of providing better vision

will require practitioners to become well-versed in

the optics and techniques of more approaches.

“Surgeons will need to be skilled to use new

IOLs and perform new procedures, including

those needed to handle associated complica-

tions and for removing IOLs as better alterna-

tives emerge,” he said. “We will need better

understanding of the optics and vision of the

eye and of the impact of our procedures on vi-

sion and measures of quality of vision as well

as skills and knowledge to address potential

problems of reduced contrast sensitivity and

to enhance corneal and IOL optics.”

■ Surgical outcomes will be improved by more ac-

curate methods for IOL calculation, although achiev-

ing perfection will remain a challenge for some. Al-

ready, more accurate measurements of axial

length and corneal power are available with

newer technology. However, there is a need for

better prediction of the effective lens position.

“A lot of progress has been made with new

IOL calculation formulas, such as from Thomas

Olsen, MD, and Jaime Aramberri, MD, and we

are working on engineering approaches for IOL

calculations,” he continued. “However, one re-

maining challenge is the ability to understand

the patient’s anatomy enough to predict whether

there will be a postoperative shift in lens position.”

Better solutions also are needed for calculat-

ing IOL power in eyes with a history of kera-

torefractive surgery as the number of such pa-

tients presenting for cataract surgery grows.

“So far in 2010 there were more than 61,000

visits to the American Society of Cataract and

Refractive Surgery Web site for postrefractive

surgery IOL calculations,” Dr. Koch said. “Using

the array of available formulas can generate a

dozen possible outcomes.

“With imperfection comes complexity,”

he said. “Ultimately, intraoperative measure-

ments will be more widely utilized, and this

approach is already being employed by some

for determining sphere and cylinder. In the fu-

ture, we can expect it will be applied to correct

higher-order aberrations and adjust achieved

accommodation.”

■ With the aim of delivering optical excellence

and patient satisfaction, cataract surgeons also will

need better ways to assess patients preoperatively

in terms of their anatomy, optics, and expectations.

For example, improved methods are needed for

determining individual tolerance for monovi-

sion, and as accommodating IOLs emerge, the

question arises whether there will be patient-

specific features in anatomy, corneal optics,

or retinal/neural factors affecting the perfor-

mance of this technology.

“Some retinas have potential for 20/10 vision

and others are 20/25 retinas, and the differ-

ence can determine who does well with cer-

tain technologies,” Dr. Koch said.

This is an area of research interest for Dr.

Koch, who together with Li Wang, MD, PhD,

performed corneal depth of focus measure-

ments and determined there is a wide range

among normal eyes and an even bigger spread

among eyes with a history of LASIK.

“Although we have yet to translate this infor-

mation into something with clinical applicabil-

ity, this is the type of direction where we need

to move in trying to identify which patients may

do better with which technologies,” he said.

■ Surgeons already are facing patients who are

incredibly well informed, but they can expect that

situation to become amplified in the future. Rec-

ognizing that the Internet is a leading source

for consumer information suggests a need for

developing better patient education tools that

will provide accurate information and combat

misinformation, he said.

■ Financial constraints will remain an ongoing con-

cern, requiring surgeons to develop strategies to be-

come more efficient practically and financially. This

need is particularly pressing considering a num-

ber of factors, including the projected increase

in cataract procedures performed annually, the

impending ophthalmologist workforce short-

age, and the position of cataract surgery as a

prime target for reducing the Medicare budget.

“We need to do a good job of demonstrat-

ing our value and the complexity of what we

do,” Dr. Koch said.

■ Ophthalmologists will need to work hard as their

patients’ advocates, but be prepared for major battles

on the regulatory front, relating to financial and reim-

bursement issues, and as their workload escalates.

“Things could get better, for example with

expansion of patient cost sharing,” he said.

“This strategy would increase patient involve-

ment and choice in medical decision making

while simultaneously improving the solvency

of Medicare and increasing our field’s desir-

ability for physicians and industry.”

Dr. Koch concluded by issuing his colleagues

a call to action.

“We need to enhance resident and practi-

tioner training to meet the new technical and

optical challenges, rethink ways of financing

medical care, and work to promote access to

new technology,” he concluded. “Ophthalmolo-

gists need to become involved in society and

in our societies to achieve these goals.”OT

fyiDouglas D. Koch, MDE-mail: [email protected]

Dr. Koch is a consultant to or is an equity owner

in several companies that manufacture or are

developing technology relevant to cataract surgery.

Dr. Koch


RefractiveContinued from page 1

Dr. Donnenfeld is using the iFS femtosecond

laser (Abbott Medical Optics [AMO]) to create

oval LASIK flaps.

“For the first time, we can customize our

flaps in a manner similar to customized ab-

lations,” he said. “We can make reverse side

cuts that give added stability, reduce the risk of

dry eye, and improve the refractive accuracy.”

Dr. Donnenfeld is a founding partner of Oph-

thalmic Consultants of Long Island and Con-

necticut, clinical professor of ophthalmology,

New York University Medi-

cal Center, New York, and a

trustee of Dartmouth Medi-

cal School.

Peter S. Hersh, MD, also

expressed enthusiasm for this

technology.

“We are seeing from data

presented at the American Academy of Ophthal-

mology [AAO] meeting that we have the ability

to make very controlled incisions and capsuloto-

mies,” he said. “The ability to ease the removal

of the nucleus is going to be a great advance in

cataract surgery. This technology will also, I be-

lieve, help in the development of new IOLs, po-

tentially IOLs to correct presbyopia, by control-

ling the size and the shape of the capsulotomy.”

Dr. Hersh is director, Cornea and Laser Eye In-

stitute—Hersh Vision Group, clinical professor of

ophthalmology, and chief, Cornea and Refractive

Surgery, University of Medi-

cine and Dentistry-New Jersey

Medical School, Newark, NJ.

Marguerite McDonald, MD,

also pointed to the continu-

ing buzz surrounding fem-

tosecond laser technology as

it is applied to LASIK.

“The talk about the femtosecond laser domi-

nated in 2010,” she said. “This technology pro-

vides both ‘reverse bevel’ edges, which have

been proven to increase flap adherence, as well

as reliably thinner and consistently planar flaps.

“In addition, several investigators around

the globe are using femtosecond technology for

the ‘FLEX’ (femtosecond lamellar extraction)

and ‘SMILE’ (small incision lenticule extrac-

tion) procedures, which involve the creation

of a refractively powered stromal lenticle that

is removed from under a classic LASIK flap

(FLEX) or through a small incision (SMILE).

The excimer laser is not used in these two pro-

cedures; all the cuts are made with the femto-

second laser,” said Dr. McDonald, clinical pro-

fessor of ophthalmology, New York University

Langone Medical Center, New York, and adjunct

clinical professor of ophthalmology, Tulane Uni-

versity Health Sciences Center, New Orleans.

Femtosecond cataract surgery is associated

with a number of advantages. First, the preci-

sion and, therefore, the safety of the surgery

will increase to a new level.

“The surgery is more precise because the inci-

sions are accurate,” Dr. Donnenfeld said. “The lim-

bal incisions are three-plane and are significantly

less likely to leak. The limbal relaxing incisions

have uniform depth and length and will convert

the incisions from the art they have achieved to

a science. For the first, time limbal relaxing in-

cisions will emerge as a technology that all oph-

thalmologists can create to reduce astigmatism.”

He also pointed out that currently only about

20% of ophthalmologists perform limbal relax-

ing incisions and 70% of patients have cylinder

of 0.5 D or more, which is visually significant.

“This technology creates an enormous op-

portunity for ophthalmologists to treat residual

astigmatism, which is the rate-limiting step for

most surgeons in improving visual outcomes

after cataract surgery,” he added.

A second advantage of femtosecond cat-

aract surgery is the ability to create better

capsulotomies.

“A large capsulotomy allows the lens to vault

forward and have more power, while a small cap-

sulotomy holds the lens back, resulting in a lens

with reduced power,” Dr. Donnenfeld said. Pa-

tients can have a shift in power of 0.5 to 1 D in re-

fraction as a result of the size of the capsulotomy.

“Creating uniform capsulotomies in all cases

previously was impossible. This is not so any-

more. With the femtosecond laser, the capsulot-

omy can be created and be accurate to within

0.1 mm. This will provide much more refractive

stability and accuracy,” Dr. Donnenfeld said.

From a safety standpoint, every aspect of the

surgery will be safer and become LASIK-like

in accuracy and safety. While cataract surgery

is extremely safe, Dr. Donnenfeld believes that

femtosecond cataract surgery will raise the

bar even higher.

“The incisions will be self-sealing, the inci-

dence of endophthalmitis will decrease, laser

capsulotomy decreases the incidence of tears

and vitreous loss, and with the femtosecond

laser, dramatically less energy is used in the

eye compared with phacoemulsification,” he

commented. As a result of less energy use in

the eye, there is less corneal decompensation,

glaucoma, zonular weakness, dropped nuclei,

and development of opacification.

Several femtosecond platforms (LenSx, LensAR,

Opti Medica) either received FDA clearance or

are undergoing review (see related story, Page 8).

Lenticular imaging“In 2010, the LensAR team has made signifi-

cant headway with regard to lenticular imag-

ing,” Dr. McDonald said.

“The LensAR 3D-CSI Automated Imaging

and Measurement Technology uses novel tech-

niques to provide high-resolution reconstruc-

tion of the anterior segment, from the corneal

surface to the posterior surface of the lens. It

is the only femtosecond cataract laser with

this depth of field, which is critical to prevent

rupture of the posterior capsule,” Dr. McDon-

ald explained.

“3D-CSI stands for ‘3-Dimensional Confo-

cal Structured Illumination.’ It has this name

because it reconstructs a three-dimensional

model of the eye using an imaging and measur-

ing system that is confocal with and uses the

same optical pathway and measuring system

as the treatment laser,” she said. “Structured

illumination is the multiple imaging of a fixed

structure to enhance resolution. It is also the

only laser being tested to soften a clear, hard-

ened lens for the amelioration of presbyopia.”

Dr. McDonald

Figure 1 Example of graphic user interface

of femtosecond laser. X-Y positioning of

capsulorhexis and corneal incisions (left);

OCT image used to position lens liquefaction,

capsulorhexis, and corneal incisions on the

Z-axis (right). (Figure courtesy of LenSx Lasers)

Take-Home Message

The most important advance in refractive

surgery in 2010 that is being touted by surgeons

is the femtosecond laser for cataract surgery

and creation of LASIK flaps, which by all

accounts will raise the bar for visual outcomes.

Surgical advances also have been observed in

the treatment of keratoconus and other corneal

disorders and presbyopia. And an avalanche of

new dry eye, anti-allergy, anti-inflammatory, and

anti-viral medications entered the marketplace.

Dr. Hersh


SPECIAL SECTION

Year in Review

See Advances on page 20

A second technologic advance that also will

improve outcomes is intraoperative aberrom-

etry (ORange, WaveTec), which provides real-

time refractive measurements during surgery.

“This year, the company developed the abil-

ity to do aphakic intraoperative refractions,

which allows us to predict the postoperative

results in the operating room. This allows pa-

tients with problematic refractions to obtain

good outcomes, such as those who had un-

dergone LASIK or PRK,” Dr. Donnenfeld said.

As a result of the improved accuracy, there

has been a decrease in the number of enhance-

ment surgeries following LASIK, from 40% to

less than 10%. Intraoperative aberrometry also

enables the placement of toric IOLs in the right

position, placement of limbal relaxing incisions

and adjustment, and treatment of patients with

extreme myopia or hyperopia, according to Dr.

Donnenfeld.

Surgeons also may soon have a promis-

ing device for their patients with glaucoma.

The FDA received an approval vote from the

panel on a new microinvasive glaucoma device

(iStent, Glaukos Corp.).

“The use of these devices

is well within the skill set of

all cataract surgeons and will

allow them to treat glaucoma

and dramatically decrease

the complications associated

with traditional glaucoma

surgeries,” Dr. Donnenfeld

said. The devices are not as-

sociated with development

of endophthalmitis because

they are ab interno.

The device seems to be

well tolerated and is expected

to be commercially available

within the next few months.

Glaukos Corp. will be the first

to receive approval.

Other exciting technol-

ogies include the KAMRA

corneal inlay introduced by

AcuFocus. This inlay has a

small pin hole for patients

with presbyopia.

“This is the first such treat-

ment for presbyopia that I

would consider for my own

eyes,” Dr. Donnenfeld said.

This inlay is in the FDA pipe-

line and results are thus far

encouraging.

Surgical advancesA variety of lamellar surger-

ies—Descemet’s stripping automated endothe-

lial keratoplasty (DSAEK), anterior lamellar kera-

toplasty for keratoconus, and femtosecond laser

for corneal procedures—have been receiving in-

creasing attention. Combination surgeries, i.e., of

femtosecond procedures and deep lamellar pro-

Figure 2 Intraoperative wavefront

aberrometry (ORange Intraoperative

Wavefront Aberrometer, WaveTec Vision)

demonstrates the ability to measure

refractive error accurately in aphakic eyes.

(Photo courtesy of WaveTec Vision)

‘[The emergence of femtosecond cataract

surgery] . . . is indeed a major story for

the next decade because cataract surgery

is now moving in a different direction for

the first time since the introduction of

phacoemulsification.’

Eric D. Donnenfeld, MD

19DECEMBER 15, 2010 / www.ophthalmologytimes.com

SPECIAL SECTION

Year in Review

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AdvancesContinued from page 19

cedures, are very effective for patients with stro-

mal disease and a normal Descemet’s membrane

and endothelial cells.

“We have been having very good success

with the patients with keratoconus particu-

larly,” Dr. Hersh commented.

In 2010, he pointed out, DSAEK and the pos-

terior lamellar procedures have overtaken pen-

etrating keratoplasty as the treatment of choice

for treating endothelial problems, such as Fuchs’

dystrophy and bullous keratopathy.

“Over the past year, the preponderance of cor-

neal surgeons has opted to perform DSAEK and

the posterior lamellar procedures,” Dr. Hersh said.

There also has been renewed interest in am-

niotic membrane graft transplantation with Am-

bioDry2 and Amnio5 grafts (IOP Inc.), which

are processed amniotic membrane allografts.

These tissues are dehydrated and terminally

sterilized under strict, quality-controlled pro-

tocols. These are ideal for treating pterygium,

conjunctival chalasis, corneal ulcerations and

perforations, chemical and thermal burns, bullous

keratopathy, and ocular dermoids and tumors.

“After a brief training session, these tis-

sues are quite easy to use and make the cases

go faster, [because] they are attached with

Tisseel glue (fibrin sealant, Baxter) instead

of sutures,” Dr. McDonald commented. “The

patients have less postoperative pain, higher

success rates, and better cosmetic results. I

have used the grafts successfully to treat con-

junctival chalasis, an unrecognized/under-

recognized condition.

“I am convinced that the few individuals

with dry eye who do not [have a response] to

[cyclosporine ophthalmic emulsion (Restasis,

Allergan)] and the other adjunctive dry eye

therapies often have a mechanical problem

such as conjunctivochalasis that can only be

repaired with surgery,” Dr. McDonald said.

Collagen cross-linking has been receiving a

great deal of attention over the past year for treat-

ing keratoconus and corneal ectasia, according

to Dr. Hersh. The final data analysis in the U.S.

clinical trial of collagen cross-linking is under way.

“We hope this will lead to potential approval

of the cross-linking procedure,” he said.

New cross-linking trials are being conducted

by Avedro and Topcon. Dr. Hersh, who is the

medical monitor of the Avedro trial, reported

that this U.S. multicenter trial will be using

a short cross-linking technique in which the

treatment time is reduced markedly and that

enrollment is currently under way.

Dr. Hersh and colleagues reported data from

a controlled, randomized, prospective study of

corneal cross-linking at the 2010 AAO annual

meeting. In a subgroup of 85 patients, the in-

vestigators found generally good results follow-

ing corneal collagen cross-linking in these pa-

tients (J Cataract Refract Surg. 2010, in press).

“The patients had a significant increase in

the uncorrected visual acuity, the best-corrected

visual acuity, and improvement in the steep-

ness of the cone,” he said.

Clinical trials of a new microwave technology

(Keraflex, Avedro) to reshape the cornea are

also currently ongoing in Europe. This proce-

dure, according to Dr. Hersh, is used in patients

with keratoconus to flatten the cones further.

“The preliminary results indicate that a

number of patients with keratoconus treated

in a clinical trial in Istanbul, Turkey, have

achieved encouraging results with flattening

of the cones and increased corneal symmetry.

Collagen crosslinking is combined with the

Keraflex procedure to decrease progression of

keratoconus as well.

The year 2010 saw the FDA approval of larger

Intacs segments (Addition Technology), the 400-

and 450-μm segments, and a thinner 210-μm

segment.

“These inlays increase the range of correc-

tion in patients with keratoconus,” Dr. Hersh

said. He also explained that surgeons are rec-

ognizing that the use of asymmetric segments

‘Many patients who

are dissatisfied

after implantation

of a multifocal IOL

have unrecognized/

untreated dry eye or

blepharitis or both. The

same situation is true

after LASIK’

Marguerite McDonald, MD

‘Over the past year,

the preponderance

of corneal surgeons

has opted to perform

DSAEK and the

posterior lamellar

procedures.’

Peter S. Hersh, MD

Figure 3 Slit lamp photo of the intracorneal inlay for presbyopia (KAMRA, AcuFocus).

(Photo courtesy of AcuFocus Inc.)


SPECIAL SECTION

Year in Review

See Blepharitis on page 22

is proving to be advantageous to improve the

corneal symmetry.

Corneal inlays also are being used to treated

presbyopia. AcuFocus (ACI 7000 corneal inlay)

and ReVision Optics (PresbyLens Corneal Inlay)

are conducting studies of intracorneal inlays.

Data collection is under way with potential

submission to the FDA.

“The AcuFocus inlay is a unique presbyopia

solution, since it relies on an increased depth of

field caused by the pinhole, rather than multi-

focality or monovision, which is the mainstay

of other presbyopia solutions. Because of this,

patients generally retain excellent distance vi-

sion in the eye with the inlay,” said Dr. Hersh,

who is an investigator for AcuFocus.

Medical advancesDr. Donnenfeld and Dr. McDonald both men-

tioned the importance of gancyclovir ophthal-

mic gel (Zirgan, Bausch + Lomb), the first new

antiviral drop introduced since 1980.

This drop, which hit the market early in 2010,

is dramatically more efficacious, less toxic than

trifluridine (Viroptic, Glaxo Wellcome), which

is preserved with thimerosal, and does not re-

quire refrigeration. The drug is better tolerated,

promotes more rapid healing, and is instilled

five times a day compared with nine times daily

for trifluridine, Dr. Donnenfeld said.

Dr. McDonald and Dr. Donnenfeld both also

mentioned the 2010 release of ketorolac tro-

methamine ophthalmic solution (Acuvail, Al-

lergan), a nonsteroidal drug that is adminis-

tered twice daily for pain and inflammation

following cataract surgery. This drug is more

comfortable for patients and therefore tolerated

better because of the vehicle. The contact time

with the eye also has been increased, which

results in greater drug concentrations in the

anterior chamber.

Used four times daily for the first 3 days

after PRK, ketorolac tromethamine ophthalmic

solution is very effective for relieving postop-

erative pain, foreign body sensation, and pho-

tophobia, Dr. McDonald added.

Difluprednate 0.05% (Durezol, Alcon), the

strongest topical corticosteroid available, is four

to six times stronger than prednisolone ace-

tate 1.0%, according to Dr. Donnenfeld, and,

when given in a pulse dose immediately before

cataract surgery, results in significantly im-

proved visual results with less corneal edema

and macular swelling. The drug suppresses

inflammation after cataract surgery and short-

ens the treatment time both by the number of

doses and the length of treatment.

Dr. Donnenfeld is now using difluprednate

0.05% in all of his cataract surgeries with dos-

ing every 15 minutes starting 2 hours before

the surgery, three times in the recovery room

following surgery, and then four times a day

for the first week and two times a day for a

second week. The study was presented at the

AAO annual meeting in Chicago.

“This drug is quite effective in suppressing

inflammation; if there is a spike in IOP, it can

occur earlier in the course of the treatment than

with other topical steroids, and the elevation

can be high. This is a very good drug to have

in the armamentarium when it is used appro-

priately,” Dr. McDonald advised.

She uses it to treat patients with episcleritis,

uveitis, and “hot eyes” in general, stepping down

to prednisolone acetate (Pred Forte, Allergan)

or lote pred nol etabonate (Lotemax, Bausch +

Lomb) when appropriate.

Dr. McDonald pointed out the increasingly

keen interest in the development of dry eye

treatments. Restasis is still the only FDA-ap-

proved medication for dry eye that is more than

palliative, i.e., it actually treats the cause of

the disease; now numerous companies have

therapeutic drugs in the pipeline as well.

The Baby Boomers and their aged parents

are living longer, which increases the chances

of developing dry eye. Many patients in these

age groups also are taking antidepressant, an-

tiarrhythmia, and cholesterol-lowering drugs,

most of which dry out their eyes further. Women

also develop dry eye in response to hormonal

changes. The number of potential patients is

tremendous and growing, she explained.

Focus Laboratories has introduced an artifi-

cial tear formulation to the market that is avail-

able only by prescription. FreshKote lubricant

eye drops are indicated for treating patients

with moderate to severe dry eye.

“This formulation contains all three layers of

the tear film—lipid, aqueous, and mucus—and it

is covered by most patients’ insurance,” she said.

This year the impact of meibomian gland dys-

function is becoming increasingly recognized

as a major contributor to ocular surface disease

and a contributing factor to evaporative dry eye.

Azithromycin ophthalmic solution (AzaSite, In-

spire Pharmaceuticals) applied once or twice

daily has emerged as the first real therapy for

managing meibomian gland dysfunction.

“This is a very simple, patient-friendly ther-

apy that is achieving good results in dry eye

management,” Dr. Donnenfeld said.

Blepharitis and dry eye have been overlooked

historically, according to Dr. McDonald, and

are now more likely to be treated.

“Many patients who are dissatisfied after

implantation of a multifocal IOL have unrecog-

nized/untreated dry eye or blepharitis or both.

The same situation is true after LASIK. An un-

happy patient who underwent LASIK can have

20/16 vision postoperatively but poor quality

of vision due to unrecognized/untreated dry

eye,” she said.

“Happily, we now have some drugs that are

quite effective for treating blepharitis, such as

[azithromycin]. Some doctors have their patients

administer [azithromycin] as they would any

other drop; others—such as myself—instruct

their patients to rub it into the lid margins. The

Blepharitis Working Group recently presented

its findings; this international group of experts

cited [azithromycin] as a first-line therapy for

blepharitis. We look forward to the publication

of their report in the peer-reviewed literature,”

Dr. McDonald said.

There are two new options for treating blepha-

ritis, both from Alcon: Systane Balance, an arti-

ficial tear formulation designed to help patients

with evaporative dry eye caused by blephari-

tis, and TobraDex ST, a prescription medica-

tion to treat blepharitis, Dr. McDonald added.

Also in the dry eye arena, attention to the

‘The market analysts now believe that the oldest

members of the Baby Boom generation are starting to

become a bit too old for LASIK due to their lenticular

changes; that group is now opting for refractive lens

exchange/early cataract surgery with presbyopia-

correcting IOLs.’



SPECIAL SECTION

Year in Review

BlepharitisContinued from page 21

impact of tear osmolarity is a major step in the

diagnosis of dry eye. The TearLab device (Tear-

Lab Corporation) allows diagnosis of dry eye

more accurately, Dr. Donnenfeld said.

“Besides aiding in the diagnosis of dry eye,

tear osmolarity testing also may allow us to

monitor the effects of treatment,” Dr. McDon-

ald said. She added that there will be a CPT

code for this test as of January 2011.

For patients with exposure keratitis, there are

ever more bland ointments at their disposal, in-

cluding SteriLube petrolatum ophthalmic oint-

ment from Fera, Refresh PM ointment from Al-

lergan, and Advanced Eye Relief Night Time

Lubricant Eye Ointment from Bausch + Lomb.

“The increased presence of bland ointments

in the marketplace is a result of the increas-

ing incidence of exposure keratitis due to lag-

ophthalmos among Baby Boomers and their

parents,” Dr. McDonald said. She likes to treat

her patients who have moderate to severe dry

eye with a regimen that includes ointments

such as these to drive moisture into the oc-

ular tissues while the patients are sleeping,

even without the presence of exposure kerati-

tis, she explained. “Though I consider cyclo-

sporine emulsion to be the foundation of dry

eye treatment, supplemental therapies such as

artificial tears, nutritional supplements, and

bland ointments at night are extremely help-

ful,” Dr. McDonald explained.

In the allergy arena, ISTA Pharmaceuticals

introduced bepotastine besilate 1.5% ophthal-

mic solution (Bepreve), a twice-daily formu-

lation. In the non-steroidal anti-inflammatory

drug (NSAID) arena, ISTA introduced bromfenac

0.09% ophthalmic solution (Bromday), a topi-

cal once-a-day NSAID agent for inflammation

and pain following cataract surgery.

IOLsRefractive surgeons in the United States are await-

ing the AcrySof Cache phakic angle-supported

IOL (Alcon), according to Dr. McDonald, be-

cause the clinical trial data are impressive. This

IOL is designed for patients who have moderate

to high levels of myopia and cannot undergo

a LASIK procedure. The lens will be available

in four lengths with powers ranging from –6.0

to –16.5 D and increasing in 0.5-D increments.

She also noted that presbyopia-correcting

IOLs are gaining steadily and increasing mar-

ket penetration.

“The market penetration has been slower

than originally predicted, but increasing none-

theless. These IOLs are improving with each

new iteration, and the surgeons and their staff

are getting more proficient at explaining the

advantages and disadvantages of the lenses to

their patients,” Dr. McDonald said.

The Synchrony (AMO) IOL is an accommo-

dating IOL that also is in the FDA pipeline and

likely will be the next presbyopia-correcting

lens to be approved.

Contact lenses and solutionsThe past year saw a great deal of attention turn

toward multipurpose contact lens solutions, Dr.

McDonald recounted. Over the past few years,

Bausch + Lomb and AMO have both recalled

contact lens solutions.

“The focus regarding these solutions has

been on making them safe, because patients

abuse their contacts and solutions and do not

clean the contact lens cases. It has been an im-

portant bioengineering challenge to make solu-

tions that can withstand abuse while protect-

ing patients from sight-threatening infections,

and simultaneously providing patients with

increased comfort and wear time,” she said.

AMO recently received FDA approval of a

new contact lens solution, RevitaLens Ocutec,

a next-generation, rub-and-

rinse, multipurpose disin-

fecting solution for use with

silicone hydrogel and con-

ventional soft contact lenses.

“This formulation provides

enhanced protection and com-

fort,” Dr. McDonald said.

She also pointed out that there has been a

great deal of research lately into how to in-

crease the penetration of contact lenses into

the market.

“Only about 20% of potential candidates for

contact lenses actually wear them,” Dr. McDon-

ald said. “Annually, there is turnover such that

the market penetration has reached a steady

state, that is, the same number of people begin

to wear contact lenses each year as the number

who drop out from wearing them.

“Due to breakthroughs in materials science

and pharmacology, 2011 to 2012 will likely see

an increase in the market penetration of con-

tact lenses,” Dr. McDonald added.

The remarkable increase in methicillin-resis-

tant Staphylococcus aureus (MRSA) has resulted

in increasing resistance to the fluoroquinolones.

“The American Association of Cataract and

Refractive Surgery [ASCRS] found that, in 2002,

MRSA was not even on the radar screen. The

incidence of infection after LASIK in 2002 was

about one in 3,000 cases, but that incidence had

increased to an alarming one in 1,200 cases by

2008, and MRSA had become the most prevalent

causative pathogen,” Dr. McDonald emphasized.

In response to this, Bausch + Lomb intro-

duced a fluoroquinolone, besifloxacin ophthal-

mic suspension 0.6% (Besivance), developed

specifically for ophthalmic use in 2009. In clini-

cal efficacy studies and nonclinical resistance

studies, besifloxacin was associated with a lower

incidence of resistance development.

This year also saw the launch of Zymaxid (Al-

lergan), a 0.5% gatifloxacin solution. It is a higher

concentration than Allergan’s own Zymar, which

is a 0.3% solution. Very recently, the FDA ap-

proved Alcon’s 0.5% moxifloxacin solution in xan-

than gum, which will be released under the trade

name of Moxeza. It has the same concentration

of moxifloxacin as Alcon’s own Vigamox, but the

xanthan gum is a different, longer-lasting base.

Market trendsA shift has become apparent recently in the

patient populations that are choosing to un-

dergo LASIK.

“The market analysts now believe that the

oldest members of the Baby Boom generation

are starting to become a bit too old for LASIK

due to their lenticular changes; that group is

now opting for refractive lens exchange/early

cataract surgery with presbyopia-correcting

IOLs. Their children, the “Echo Boomers,” are

the group currently embracing LASIK. This

represents a real change in marketing and po-

sitioning of practices,” Dr. McDonald said.OT

Figure 4 A new solution

(RevitaLens Ocutec, AMO)

provides disinfection of

silicone-hydrogel and

conventional soft contact

lenses. (Photo courtesy of AMO)

fyiEric D. Donnenfeld, MDE-mail: [email protected]

Dr. Donnenfeld is a consultant to Abbott Medical Optics,

Alcon, Allergan, Bausch + Lomb, Inspire, and LenSx.

Peter S. Hersh, MDE-mail: [email protected]

Dr. Hersh is a consultant to AcuFocus and Avedro.

Marguerite McDonald, MDE-mail: [email protected]

Dr. McDonald is a consultant to Abbott Medical Optics,

Alcon, Allergan, Bausch + Lomb, Fera Pharmaceuticals,

FOCUS Labs, IOP Inc., Ocularis Pharma, and Santen.


SPECIAL SECTION

Year in Review


Manage-

In Brief

23

Manage-

In Brief

Management Solutions for your DispensaryManagement Solutions for your Dispensary

Gett

y Im

ages/

Fuse

23

Finalists announced

Labs, retailers

vie for awardPinellas Park, FL—Transitions

Optical Inc. has announced

the three finalists for its

2010 U.S. lab of the year

award: Central Optical, To-

ledo Optical Laboratory Inc.,

and Walman Optical.

“When selecting the final-

ists, we look at more than

the lab’s overall share of

Transitions lenses and per-

centage of growth—we take

into consideration innovation

and creativity in executing

programs, commitment to

educating staff and custom-

ers, and overall passion

for and devotion to the . . .

brand,” said Brian Hauser,

director, lens manufacturer

and trade channel sales,

Transitions Optical.

The winner will be an-

nounced Jan. 25 during an

awards ceremony at the 15th

annual Transitions Academy

in Orlando.

For the first time, Transi-

tions Optical also will recog-

nize a national and regional

retailer of the year, as well

as a vision benefits broker of

the year.

Finalists for the national

retailer of the year award

include Eye Care Centers of

America & Empire Vision and

National Vision Inc. Finalists

for the regional retailer of

the year award include Eyear

Optical, Henry Ford Optim-

Eyes, and SVS Vision Optical

Centers.

The vision benefits broker

of the year finalists will be

announced this month.OT

By Donna A. Suter

Social gatherings are filled with people

talking about their latest self-improvement

efforts. With today’s consumer investing

in everything from onabotulinumtoxinA (Botox,

Allergan) to bunion removal, it’s no wonder that

consumers are asking opticians, “Isn’t there any-

thing else?”

To paraphrase best-selling author and sales guru

Jeffrey Gitomer: in optical sales, you earn money

by having answers that others don’t.

Opticians, feeling the pressure to offer the lat-

est and the greatest, may be wondering whether

boutique spectacle lenses should be added to their

product mix. Often, a request (or complaint) from

a consumer is cited as one of the reasons given

by practices that change wholesale lab services.

Because many fabrication centers now are owned

by brand-specific providers, “different” often means

purchasing from a smaller, independent lab.

Although consumer preference is important and

most business start-up specialists recommend that

a small business—a dispensary should be run as

a separate business and have its own set of finan-

cials—have accounts with at least three different

labs, re-vamping spectacle products should not be

just consumer-driven but confirmed through fi-

nancial analysis.

The underlying questions for management to

consider are:

■ How will changing manufacturers affect profit?

■ Will a change in all-purpose lens supplier af-

fect demand and will consumer utilization con-

tinue at past levels?

■ Because spectacle lenses are customized, will

there be a change in production time?

■ Will a change in provider shift when payments

are due and affect cash flow?

Time to change labs?Here are some points to consider before making a switch

Personalized solutions

See Labs on page 24

Take-Home Message

With more than 145 million Americans wearing

prescription eyeglasses, offering personalized

solutions is not just a marketing niche but a

consumer-driven mandate. The selection of eyeglass

lenses available today is vast and the optimum

product is out there. Using the suggestions in this

article as the foundation of your analysis, you will be

able to choose a lab partner confidently.

DECEMBER 15, 2010 / Ophthalmology Times24 DECEMBER 15, 2010 / Ophthalmology Times24

SolutionsSolutions


author info Donna A. Suter is president of

Suter Consulting Group, offering

practical, no-nonsense practice

management consulting. To discuss

practice efficiencies and how to

become more effective in patient

communication, contact Suter at

800/249-5201 or [email protected].

‘You may discover

that . . . this new lab

. . . offers a unique

selling proposition

that distinguishes your

dispensary’s product

and service from its

competitors.’

Donna A. Suter

■ Will the sales team (floor opticians) be

concerned about quality and offer resistance?

Analyzing cost, product availabilityA quick way to see how an across-the-board

shift in wholesale sources would affect profit

is to pull 25 random spectacle lens purchases

no older than 90 days. By keeping the records

current, consumer product preferences (utili-

zation) will be weighted and vision plan aging

will be easy to note. Raw data collection should

not take longer than 5 business days.

After building this spreadsheet, meet with a

representative of the prospective supplier and

request wholesale prices as well as manufac-

turer-recommended retail price points. Create

a second spreadsheet using the same purchase

data with the projected wholesale, retail (manu-

facturer’s suggested retail price), and collections.

Do the numbers suggest that a partnership

with a new spectacle lens source is viable? Be-

cause a large percentage of people with healthy

eyes now are using vision plan policies when

purchasing eyewear, the next step is to check

with their respective representative to confirm

that a change in spectacle lens technology or

source does not change reimbursement rates

or flag your account for additional fees.

Questions to ask a vision plan representa-

tive might include:

■ Will this lab be considered out-of-network?

■ Because the actual lens technology is an

upgrade to XYZ, will the dispensary be reim-

bursed more?

■ Under the terms of participation in this

plan, will I be paying a fee to a lab not used

even if I process the order through this spe-

cialty lab?

■ Just as a reality check, may I give you a

few real-time examples and you tell me what

I would be paid?

Note: The landscape of today’s customer ser-

vice representative very well might be a virtual

office. The above questions might be typed into

a portal or a change in compensation estimated

using an online reimbursement calculator. Do

not be frustrated if the closest you come to a

person is “live chat.”

On-site lab?Now that you have performed this analysis,

you may be surprised at the low profit margin

you are netting from certain lens options and

packages. If you are wondering if your dispen-

sary should not be positioned with designer/

boutique lenses but economy/affordable lenses,

investigate adding an on-site lab. An on-site

facility may eliminate using a wholesale lab.

Because start-up capital is required, adding a

financial review of product utilization over the

past 12 months is recommended.

At this point in the analysis you may dis-

cover that, although it is not advantageous to

shift the bulk of lens production from your

current source, this new lab—the source of an

emerging technology, unique pairing with pat-

ented features that enhance clarity or durabil-

ity, or specialty lenses—offers a unique selling

proposition that distinguishes your dispensa-

ry’s product and service from its competitors.

Enlisting opticiansBecause you have taken the time to analyze

a sampling of patient prescriptions, now you

can present with confidence the boutique spec-

tacle lens and its supplier to your floor opti-

cians. Opticians are wonderful, caring people

and likely will express loyalty to their current

source and “brand.”

They also, naturally, will be concerned with

consumer affordability, optical clarity, and du-

rability. A good optician will have technical

questions about Abbe value, tensile strength,

and refractive index.

If the majority of your patients purchase pro-

gressive lenses, opticians may voice concern about

the design reference point and have questions

about aberration and prismatic power. If the lens

design is a progressive, opticians also may have

questions about how cutting the lens to fit the

frame affects the zones of vision that customize

the product to the patient’s prescription.

Depending on your patient population, the

floor opticians also might want access to an

optics specialist who can help them enhance

a basic refraction—enabling the end-use con-

sumer (the patient) to see clearly in the light-

ing conditions, or at the distance, that he or

she most needs refractive power.

Sales training supportAnother step in forging an ongoing relation-

ship is inquiring about continuous sales train-

ing. Quality sales-force support and training

are intrinsic to making the brand-owned labs

appealing to the solo practitioner.

Ask this new lab to give you a 12-month

training schedule for your opticians, and be

prepared to take notes in an ego-free fashion.

Even if they do not have the staff needed to

train your employees, your business ally should

be able to assess the technical competency of

your team and suggest performance improve-

ment goals.

Because most decisions to buy are made on

trust and relationships, word patterns that your

employees use when discussing new spectacle

lens options with patients also should be de-

cided upon in advance.

For example: “Mrs. Smith, last year you got

ABC lenses. This year we’re putting you in

XYZ lenses.”

Generally, that will prompt a firm, “No, thanks.”

Opticians should be able to describe the lenses

in terms of a use-value—what it does, not what

it is—that is greater than the price charged.

With more than 145 million Americans wear-

ing prescription eyeglasses, offering personal-

ized solutions is not just a marketing niche but

a consumer-driven mandate. The selection of

eyeglass lenses available today is vast and the

optimum product is out there. Using these ques-

tions as the foundation of your analysis, you

will be able to choose a lab partner confidently.

Will sales increase? Patients do business with

practices that employ knowledgeable people

they like and trust.

These service skills allow opticians to em-

pathize with the patients’ visual situation and

radiate the confidence that assures patients you

are recommending the best solution for their

visual problem, no matter what.OT

LabsContinued from page 23

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DECEMBER 15, 2010 / Ophthalmology Times26

SolutionsSolutions


I always get a sinking feeling when I see

someone wearing a pair of improperly

adjusted eyeglasses. I get that feeling

because the poor adjustment I see means

that somewhere an optician has been

trained improperly and is making the same

mistake on a daily basis.

The most common error I see is temples

that are fitted too closely to the patient’s

head. This has two consequences. First, it

will create a deep indentation in the side

of the patient’s head that not only can be

clearly seen but felt. Often the indentation is

so deep that it is clearly visible after the pa-

tient takes off the glasses.

Second, the inward pressure of the tem-

ples against the side of the head will make

the glasses tend to slide forward. This will

cause the patient to push the glasses con-

stantly up each time they creep down his or

her nose.

The fitting triangleOne of the keys to learning to fit eyeglasses

properly is to understand the fitting triangle.

This concept is described brilliantly by Rus-

sell Stimson in his book.1

In the chapter entitled “The Fitting Tri-

angle,” Stimson noted that the first point of

contact for a temple needs to be at the top of

the ear. The temple tip then is adjusted be-

hind the ear. Fitting the temples in this way

will cause the temple tips, not the temple, to

grip the head in such a way that the glasses

will be pulled gently backward. Therefore,

as a result of the physics involved, the eye-

glasses will want to creep up the patient’s

nose, not down. Conversely, should the first

point of contact be in front of the ear, the

temples will press constantly into the side of

the head, forcing the glasses forward.

Spring hingesThe availability of frames with spring

hinges seems to have made matters worse.

Inexperienced and ill-trained opticians rely

on spring hinges to hold poorly fitted eye-

glasses in place. The springs only work,

however, when the frame is adjusted tightly

enough for them to flex. This increases the

inward pressure of the temples against the

head. When these temples are adjusted in-

correctly, the springs will squeeze the

glasses forward forcefully and continuously.

The solutionThe solution to the problem is for the dis-

penser to bow the temples so that they con-

form to the contour of the patient’s head, not

press against it. I often test for this contour

fit by taking a piece of paper and inserting it

between the patient’s head and the temple,

about 1 inch in front of the top of the ear. If

the paper slides freely, the fit is correct; if I

cannot insert the paper or slide it freely, the

fit is incorrect.

This also is a graphic and effective way

of helping patients understand how their

glasses ought to fit. In addition, it is an ef-

fective way to demonstrate to patients that

not all opticians are equally well trained

and that all optical shops do not provide the

same level of expertise or service.

I strongly recommend that you do two

things. First, check to see whether your opti-

cian understands how to adjust frames cor-

rectly. If not, be sure that he or she receives

the proper training. Second, as you encoun-

ter patients, check to see if their eyeglasses

are adjusted properly. If they are not, direct

them to your dispensary, where they can

have the problem corrected.

If you and your optician are wise, you

will use this as an opportunity to educate

the patient about how a proper fit is part of

the value of purchasing eyeglasses from a

professional dispensary, like yours. This will

help to build your brand in that patient’s

mind and encourage those valuable word-of-

mouth referrals.OT

Reference1. Stimson R. Ophthalmic dispensing. 1st ed. Rochester,

MN: Whiting Press Inc.; 1951.

Building your brand

Tips to avoid a common adjusting errorEducate patients about proper fit, value of purchasing from professional dispensary

Take-Home Message

A common mistake made when adjusting frames

to the patient is that the temples are fitted

too closely to the patient’s head. One of the

keys to learning to fit eyeglasses properly

is to understand the fitting triangle.

Dispensing Solutions

By Arthur De Gennaro

author infoArthur De Gennaro is

president of Arthur De Gennaro

& Associates LLC, an ophthalmic

practice management firm that

specializes in optical dispensary

issues. De Gennaro is the author

of the book The Dispensing

Ophthalmologist. He can be reached at 803/359-7887,

[email protected], or through the company’s

Web site, www.adegennaro.com. He maintains a blog

at www.adgablog.wordpress.com.

Figure 1 At left, temples fitted too closely to the patient’s head is a common error. At

right, the fitting triangle shows how the first point of contact for a temple needs to be at the

top of the ear. The temple tip then is adjusted behind the ear. (Figures courtesy of Arthur De Gennaro)


SolutionsSolutions


Down time

Maximize the year-end ‘wind down’

Take-Home Message

Don’t let the slow season undermine your

success. You may feel as if there’s not a whole

lot of work in your business right now. Consider

using this down time to work on your business

so you are ramped up to deal with the busy

season just around the corner. This column

suggests some checklists to get started.

author infoRene D. Soltis, FNAO, is senior director of meetings and

education for The Vision Council,

Alexandria, VA. With more

than 34 years of experience

as a dispensing optician, Soltis

also serves as a liaison to the

conference advisory board of International Vision Expo.

N E W Y O R K

Vision VoiceBrought to you by:

By Rene D. Soltis, FNAO

Don’t let the slow season undermine

your success. You may feel as if there’s

not a whole lot of work in your busi-

ness right now. Consider using this down

time to work on your business so you are

ramped up to deal with the busy season just

around the corner. Here are a few checklists:

Practice managementGather stats and data from the past year and

assess areas for growth.

■ Ask employees for their input. Host a

staff retreat to assess personal and business

goals.

■ Prioritize all goals and objectives for

the coming year and set the budget and a

tracking and measurement plan.

■ Provide staff training. Get them up to

date on new technology. Ask reps to come

in and give new product seminars. Pump up

their sales and communication skills. Bring

in a speaker or trainer or attend local semi-

nars. Do team-building activities.

■ Offer employees holiday flex time.

■ Offer employees unpaid time off.

■ Clean up and organize all files on your

computers.

MarketingPromote impulse holiday gift purchases by

creating and displaying eyewear gift cer-

tificates or setting up gift bags/stocking-

stuffer displays (cleaners, chains, readers,

and cases).

■ Talk to each patient about using his or

her end-of-year family flex dollars to pur-

chase additional eyewear or contact lenses.

■ Don’t forget to plan next year’s market-

ing. Maybe it is just the Yellow Pages or pa-

tient reminder cards.

■ Decide how much you want to grow

your business in the coming year and create

a business plan. Pick one new opportunity

that will enable you to grow your business.

■ Explore incorporating in-office market-

ing technologies.

InventoryIdentify dead wood on your frame displays

and map a plan to eliminate it by the end of

the year. Mark it down. Donate it to charity

and take the write-off.

■ Clean all frames and demo lenses.

■ Take a physical inventory to assure lists

match what you actually have in stock.

■ Separate scrap frames into parts, which

will make it easier when looking for a spare

part.

■ Rearrange frames on displays. Consider

using sunwear on the center of the boards,

in a band around the room.

■ Check spare parts: pads, screws, etc.

Order, if necessary, and organize what you

have.

■ Do an image overhaul. Rearrange dis-

plays, change signage, and paint a wall for a

quick, fresh look and a pop of color.

■ Do a cost-of-goods analysis and change

the price list if required.

■ Purge files of old invoices and inactive

patients to expand capacity for the coming

year.

■ Do annual vendor evaluations (assess

frame turn, customer service, back-order

history, etc.) and re-allocate board space

accordingly.

■ Research new collections/vendors and

interview them to check fit and preview

collections.

■ Restock cases and organize by vendor

and designers.

■ Go through all contact lens solutions

and check and toss those that are expired.

Give away those nearing expiration as a

thank you to patients.

Machine maintenanceBring in a specialist to service all your ma-

chines and instruments.

■ Change heat transfer fluid on the tint-

ing machine.

■ Hose out the edger.

■ Check and recalibrate all instruments.

■ Research, cost out, and create a wish

list for new equipment needs.

And last, but not least, take care of you.

Don’t forget to take a couple days off your-

self so you will be rested for the coming

year!OT

Gett

y Im

ages/

Photo

gra

pher’

s C

hoic

e R

F/ T

om

Gri

ll

marketplacemarketplace DECEMBER 15, 2010 / Ophthalmology Times28

PRODUCTS & SERVICES

EQUIPMENT FOR SALE

For Products & Services advertising information, contact: Adam Julian at 800-225-4569, ext 2649 • Fax 440-826-2865 • Email: [email protected]

For Recruitment advertising information, contact: Joanna Shippoli at 800-225-4569, ext 2615 • Fax 440-826-2865 • Email: [email protected]

EQUIPMENT FOR SALE

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800-328-2020

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The only a u t h o r i z e d reseller of Carl Zeiss Meditec pre-owned diagnostic instruments in the USCME

The American Society

of Ophthalmic

Administrators’ (ASOA)

mission is described in

its tagline, “Focusing on the

BUSINESS of Ophthalmology”.

Membership is open to anyone

interested in information on

running an ophthalmology practice.

For a free trial membership click here:http://www.asoa.org/membership/free-trial/index.cfm

SPECIALIZING IN OPHTHALMOLOGY BILLING & CONSULTING

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marketplacemarketplace DECEMBER 15, 2010 / www.ophthalmologytimes.com 29

RECRUITMENT

OPHTHALMOLOGISTMontgomery, Alabama

Well established, high volume ophthalmology

group has immediate opening for exceptional,

highly motivated general ophthalmologist.

Modern, well-equipped facility and extensively

trained technical and support staff. Salary

with incentive and fast track to partnership.

Send C.V. to Roger R. Yonker, Jr.,

c/o Institute for Total Eye Care, P.C.,

4255 Carmichael Court North,

Montgomery, AL 36106

Ph: 334.277.9111

Fax: 334.270.9359

Email: [email protected]

ALABAMA MARYLAND

The Wilmer Eye Institute is seeking a clinician-educator-administrator to serve as division

director for the General Eye Service. The successful applicant will work closely with the

Assistant Chief of Service (chief resident) and the residency program director to provide

clinical/surgical teaching and supervision for the Wilmer residency. This individual also

will be the administrative director overseeing the Wilmer resident clinic. In addition to

these teaching and administrative roles, candidates will be expected to build a busy

clinical and surgical practice in comprehensive ophthalmology and to develop research

interests in residency training.

The successful applicant will be appointed to the full-time faculty of the Johns Hopkins

University School of Medicine and to the full-time active staff of the Johns Hopkins Hos-

pital. Board certifi cation or eligibility in ophthalmology is required, and fellowship training

will be considered on an individual basis. Strong candidates will have demonstrated

interest and/or experience in residency teaching and administrative leadership. Candi-

dates will be eligible for Maryland medical licensure and will pass a criminal background

check.

The Johns Hopkins University is an equal opportunity employer and does not discriminate

on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic ori-

gin, disability, marital status, veteran status, or any other occupationally irrelevant criteria.

The University promotes affi rmative action for minorities, women, disabled persons, and

veterans.

CLINICIAN-EDUCATOR-ADMINISTRATORThe Wilmer Eye Institute/Johns Hopkins Hospital

The Johns Hopkins University is a smoke-free environment and as such, prohibits smoking in all facilities.

The Johns Hopkins University is a drug-free workplace.

CC

TT

Letters of interest including three professional references and curriculum vitae should be sent by mail to:

Catherine S. Kowalewski, MBA

The Johns Hopkins Hospital/Wilmer Ophthalmological Institute600 N. Wolfe Street, Wilmer 100

Baltimore, MD 21287-0005

[email protected]

Shipman Endowed Professorship and

Chief of Ophthalmology

Applicants must have completed a board approved 3- or 4- year ophthalmology residency, be board certified or board eligible, and eligible for medical

licensure in the State of Vermont. The candidate must demonstrate strong interests and abilities in the education of medical students and residents.

As the Shipman Endowed Division Chief of Ophthalmology at the University of Vermont College of Medicine, the expectation is that the right candidate

would lead the division of ophthalmology in its delivery of exceptional clinical care while establishing strong academic and teaching programs.

Duties will include not only providing clinical care to ophthalmology patients but also guiding the clinical practice of Ophthalmology faculty, teaching the

principles of ophthalmology to medical students and undergraduate students in Allied Health programs, providing teaching experience for residents in

training, developing basic and/or clinical research, and performing additional departmental and/or divisional administrative duties as assigned by the Chair

of the Department of Surgery.

This is a full-time, 12- month, salaried, faculty appointment and carries with it attending staff privileges at Fletcher Allen Health Care

(the teaching hospital of the University of Vermont). Salary is competitive and commensurate with ability and experience.

Vermont is an outstanding environment to practice medicine. The state offers glorious four season recreational and cultural opportunities and is a wonder-

ful place to live.

Interested applicants should forward a letter of interest and curriculum vitae to:

Dr. Paul Penar

University of Vermont

111 Colchester Avenue, Fletcher 5 • Burlington, VT 05401

Email: [email protected]

Or apply on-line at:

https://www.uvmjobs.com

The University is especially interested in candidates who can contribute to the diversity and excellence of the academic community through their research, teaching,

and/or service. Applicants are requested to include in their cover letter information about how they will further this goal.

The University of Vermont is an Affirmative Action/Equal Opportunity Employer. Applications from women and people of diverse racial, ethnic and cultural backgrounds are

encouraged. Applications will be accepted until the position is filled.

VERMONT

Repeating an ad ENSURES

it will be seen and

remembered!

Advertiser Page

Advertiser IndexAdvertiser Page

Carl Zeiss Meditec Inc. CV2

Tel: 800/342-9821


Internet: www.meditec.zeiss.com/us

Genentech Inc. 5

Tel: 650/225-1000

Fax: 650/225-6000

Internet: www.gene.com

Inspire Pharmaceuticals 30, CV4

Tel: 919/941-9777

Fax: 919/941-9797

Internet: www.inspirepharm.com

ISTA Pharmaceuticals 9-10

Tel: 494/788-6000

Fax: 650/940-4710

Internet: www.istavision.com

OP-marks 19

Tel: 866/307-2757

Fax: 866/307-2758

Internet: www.opmarks.com

Rhein Medical 3

Tel: 800/637-4346

Internet: www.rheinmedical.com

Rumex International Co. 13

Tel: 877/777-8639

Fax: 727/568-0919


Internet: www.rumex.net

Vision Expo 25

Internet: www.visionexpowest.com

Wilmer Eye Institute CV3

Tel: 410/502-9636

Fax: 410/955-0807


Internet: www.hopkinsCME.edu

This index is provided as an additional

service. The publisher does not assume

any liability for errors or omissions.

B+L advises rinse-and-rub regimen

From Staff Reports

Rochester, NY—Bausch + Lomb (B+L) is providing a rub-and-

rinse regimen in the directions for use of its multipurpose con-

tact lens solutions. The FDA and several professional eye-care

associations have recommended such a cleaning regimen to

help reduce the risk of infection.

“By choosing to change our multipurpose solution label-

ing proactively to include only a rub regimen for cleaning

and disinfecting lenses, we are providing patients with the

insights we’ve gained from the 92% of eye-care professionals

who instruct their patients to rub their lenses,” said Mohinder

Merchea, OD, PhD, MBA, director of medical affairs, North

America vision care, B+L.

A product labeling transition has been under way at the

company since the beginning of the year, according to the

company. Two of its multipurpose contact lens solutions

(Biotrue and renu sensitive) already include directions to rub

and rinse lenses as part of the care and cleaning regimen. An-

other multipurpose solution (renu fresh) will undergo the label-

ing change by May in the United States.

The company’s recommended contact lens-cleaning regimen

involves rubbing each lens gently for 20 seconds before rinsing

each side of the lens for 5 seconds with multipurpose solution.

Lens-wearers then are advised to place cleaned contact lenses

in a lens case filled with fresh solution and to soak the lenses for

at least 4 hours. B+L advises that lens wearers always use fresh

solution and never reuse or “top off” solution. The company also

advises that the lens case be replaced monthly.

Joseph Barr, OD, MS, vice president, global clinical and

medical affairs, B+L, vision care, said the company will be

“bringing several additional tools to our clinical partners to help

improve patient compliance in the near future.”OT

DECEMBER 15, 2010 / Ophthalmology Times

(A(:0;,�

(azithromycin ophthalmic solution) 1%

:[LYPSL�[VWPJHS�VWO[OHSTPJ�KYVWZ0UP[PHS�<�:��(WWYV]HS!��

)90,-�:<44(9@

Before prescribing, please consult the full prescribing information.

05+0*(;065:�(5+�<:(.,AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms:

CDC coryneform group G*/HLTVWOPS\Z�PUÅ\LUaHL:[HWO`SVJVJJ\Z�H\YL\Z:[YLW[VJVJJ\Z�TP[PZ�group:[YLW[VJVJJ\Z�WUL\TVUPHL

�,MÄJHJ`�MVY�[OPZ�VYNHUPZT�^HZ�Z[\KPLK�PU�ML^LY�[OHU��PUMLJ[PVUZ�

+6:(.,�(5+�(+4050:;9(;065The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Instill ��GURS�LQ�WKH�DIIHFWHG�H\H�V��WZLFH�GDLO\��HLJKW�WR�WZHOYH�KRXUV�DSDUW�IRU�WKH�ðUVW�WZR�GD\V��DQG�WKHQ�LQVWLOO��GURS�LQ�WKH�DIIHFWHG�H\H�V��RQFH�GDLO\�IRU�WKH�QH[W�ðYH�GD\V�

*65;9(05+0*(;065:None

>(9505.:�(5+�79,*(<;065:

;VWPJHS�6WO[OHSTPJ�<ZL�6US`NOT FOR INJECTION. AzaSite is indicated for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.

(UHWO`SH_PZ�HUK�/`WLYZLUZP[P]P[`�>P[O�:`Z[LTPJ�<ZL�VM�(aP[OYVT`JPUIn patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have been reported. The potential for anaphylaxis or other hypersensitivity reactions should be considered, since patients with a known hypersensitivity to azithromycin or erythromycin were excluded from study.

.YV^[O�VM�9LZPZ[HU[�6YNHUPZTZ�>P[O�7YVSVUNLK�<ZLAs with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be H[DPLQHG�ZLWK� WKH�DLG�RI�PDJQLðFDWLRQ��VXFK�DV�VOLW�ODPS�ELRPLFURVFRS\��DQG�ZKHUH�DSSURSULDWH��ñXRUHVFHLQ�VWDLQLQJ�

(]VPKHUJL�VM�*VU[HJ[�3LUZLZPatients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

(+=,9:,�9,(*;065:The most frequently reported ocular adverse reaction in patients receiving AzaSite was eye irritation. This reaction occurred in approximately 1% to 2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included: burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, dysgeusia, nasal congestion, ocular discharge, punctate keratitis, and sinusitis.

In addition to adverse events reported from clinical trials, the following events have been LGHQWLðHG�GXULQJ�SRVW�DSSURYDO� XVH� RI� $]D6LWH��,`L! blurring, eyelid swelling, itching, pain, visual acuity reduction. .LULYHS! allergic reactions including facial swelling, hives, periocular swelling, rash, urticaria.

<:,�05�:7,*0-0*�767<3(;065:

7YLNUHUJ`Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/d. The highest dose was associated with moderate maternal toxicity. These doses are estimated to be approximately 5000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

5\YZPUN�4V[OLYZIt is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

7LKPH[YPJ�<ZLThe safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age KDYH�QRW�EHHQ�HVWDEOLVKHG��7KH�HIðFDF\�RI�$]D6LWH�LQ�WUHDWLQJ�EDFWHULDO�FRQMXQFWLYLWLV�LQ�pediatric patients one year or older has been demonstrated in controlled clinical trials.

.LYPH[YPJ�<ZLNo overall differences in safety or effectiveness have been observed between elderly and younger patients.

:;69(.,�(5+�/(5+305.Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F). Once the bottle is opened, store at 2°C to 25°C (36°F to 77°F) for up to 14 days. Discard after the 14 days.

7(;0,5;�*6<5:,305.�05-694(;065Patients should be advised to avoid contaminating the applicator tip by allowing it to WRXFK�WKH�H\H��ðQJHUV��RU�RWKHU�VRXUFHV��

Patients should be directed to discontinue use and contact a physician if any signs of an allergic reaction occur.

Patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by AzaSite or other antibacterial drugs in the future.

Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

Patients are advised to thoroughly wash hands before using AzaSite.

9_�VUS`Inspire Pharmaceuticals Inc.Licensee of InSite Vision IncorporatedManufactured by Catalent Pharma Solutions, LLCU.S. PAT NO. 5,192,535; 6,239,113; 6,569,443; 6,861,411; 7,056,893;and Patents PendingAZA-0301Revised: 11/2008

http://www.inspirepharm.com

http://www.azasite.com

Baltimore, MarylandDecember 2-4, 2010Johns Hopkins University

Turner Auditorium

Vail, ColoradoMarch 14-18, 2011Vail Mountain Marriott

Esen Akpek, MD

Eduardo Alfonso, MD

Michael Boland, MD, PhD

Scott Bower, MD, FACS

Richard Braunstein, MD

Neil Bressler, MD

Susan Bressler, MD

Peter Campochiaro, MD

Joseph Caprioli, MD

Antonio Capone, Jr., MD

John Clarkson, MD

Mary Lou Collins, MD

William Culbertson, MD

Richard Davidson, MD

Eugene De Juan, MD

Diana Do, MD

Eric Donnenfeld, MD, FACS

James P. Dunn, MD

Vikram Durairaj, MD

Robert Fechtner, MD

Stuart Fine, MD

Craig Folwer, MD

David Friedman, MD, MPH

Peter Gehlbach, MD, PhD

Dan Georgescu, MD, PhD

James P. Gills, MD

Sonny Goel, MD

John Gottsch, MD

Traudy Grande, CFP

John Grande, CFP

Michael Grant, MD, PhD

Kenneth Greenberg, MD

David Guyton, MD

Julia Haller, MD

James Handa, MD

Bonnie Henderson, MD

Allen Ho , MD

Paul Hoffman, MD, PhD

G. Baker Hubbard, III, MD

Malcom Ing, MD

Douglas Jabs, MD, MBA

Henry Jampel, MD, MPH

Albert Jun, MD, PhD

Mailk Kahook, MD

James Katz, MD

L.J. Katz, MD

Stephen Klyce, PhD

Manus Kraff, MD

Irene Kuo, MD

Stephen Lane, MD

Anat Lowenstein, MD

Naresh Mandava, MD

Samuel Masket, MD

Nancey McCann


Peter McDonnell, MD

Shannath Merbs, MD

Travis Meredith, MD

Neil Miller, MD

Kevin Miller, MD

Mark Moster, MD

Marlene Moster, MD

Louis Nichamin, MD

Terry O’Brien, MD

Scott Oliver, MD

Randy Olson, MD

Hee-Jung Park, MD, MPH

Richard Parrish, MD

Jody Piltz-Seymour, MD

Harry Quigley, MD

Pradeep Ramulu, MD, PhD

Michael Repka, MD

Jim Rienzo

James Salz, MD

Steven Schallhorn, MD

Oliver Schein, MD, MPH

Hendrick Scholl, MD, MA

Adrienne Scott, MD

Stephen Slade, MD, FACS

Ronald Smith, MD, MPH

Kerry Solomon, MD

Sherry Solomon, MD

Walter Stark, MD

Roger Steinert, MD

Doyle Stulting, MD, PhD

Prem Subramanian, MD, PhD

Michael Taravella, MD

Shachar Tauber, MD

Mark Terry, MD

John Thompson, MD

Rolando Toyos, MD

Farrell Tyson, MD

John Vukich, MD

Charles Wilkinson, MD

Helen Wu, MD

Howard Ying, MD, PhD

Sonia Yoo, MD

Donald Zack, MD, PhD

David Zee, MD

Wilmer Eye Institute at Johns Hopkins University Schoool of Medicine

Course Directors:

. Stark, MD and Neil M. Bressler, MD

Supported by:

Invited Faculty:

Mark Your Calendar!The 69th Wilmer Residents

Association Clinical Meeting

June 3, 2011

Johns Hopkins University

Turner Auditorium

Call (410) 502-9636

for more information

For further information, please contact:

Offi ce of Continuing Medical Education

Johns Hopkins University

720 Rutland Avenue, Turner 20

Baltimore, Maryland 21205-2195

P: (410) 502-9636

F: (410) 955-0807

[email protected] • www.HopkinsCME.edu

Special Features:• Coding/Reimbursement Seminar

• Practice Management

• Complimentary Financial Seminar

• Wavefront Technology

• Non-invasive Facial Rejuvenation Workshop

• HRT and OCT workshops

http://www.hopkinscme.edu

http://www.ophthalmologytimes.com

©2010 AZA-0474 July 2010 Inspire Pharmaceuticals, Inc.

AzaSite is a registered trademark of InSite Vision, Inc. All rights reserved.

By Delivering Significant Anti-Inflammatory and

Antimicrobial Effects Directly to the Site of the Problem1,2,3,4

www.AzaSite.com

Scan the code below to

see AzaSite® in action

Here’s how:

1. Visit 2dscan.com or text “SCAN”

to 43588 from your smart phone

2. Download the free application

and take a photo of the code

References: 1. Zhou N, Ma P, Li D-Q, Pflugfelder SC. Azithromycin suppresses pro-inflammatory mediators stimulated by a TLR2 ligand zymosan in human corneal epithelial cells. Poster presented at: 2009 Association for Research in Vision and Ophthalmology Annual Meeting; May 3-7, 2009; Fort Lauderdale, FL. 2. Sadrai Z, Hajrasouliha AR, Chauhan SK, Saban DR, Dastjerdi MH, Dana R. Effect of topical azithromycin on innate immune responses in experimental keratitis. Poster presented at: 2009 Association for Research in Vision and Ophthalmology Annual Meeting; May 3-7, 2009; Fort Lauderdale, FL. 3. Abelson M, Protzko E, Shapiro A, Garces-Soldana A, Bowman L. A randomized trial assessing the clinical efficacy and microbial eradication of 1% azithromycin ophthalmic solution vs tobramycin in adult and pediatric subjects with bacterial conjunctivitis. Clin Ophthalmol. 2007;1(2):177-182. 4. Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008;145:959-965. 5. IMS Health, Prescription data, May 2009 MAT vs May 2010 MAT.

AzaSite® is indicated for bacterial conjunctivitis caused by susceptible pathogens.

#PRESCRIPTION VOLUME GROWTH

Among ophthalmic antibiotics prescribed by eye care professionals5

AzaSite® (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis in patients one year of age and older caused by the following organisms: CDC coryneform group G*, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

Important Safety Information: AzaSite® should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.

In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely. Although rare, fatalities have been reported.

As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.

The most frequently reported ocular adverse event reported in clinical trials was eye irritation which occurred in 1-2% of patients. Other adverse events reported in <1% of patients included: burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, dysgeusia, nasal congestion, ocular discharge, punctate keratitis, and sinusitis. *Efficacy for this organism was studied in fewer than 10 infections.

Please see the brief summary of Prescribing Information on the next page.

http://www.inspirepharm.com

http://www.azasite.com

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