`VOL. 38, NO. 17
`
`C L I N I C A L N E W S & A N A L Y S I S
`
`ophthalmologyTimes.com
`
`F o l l o W u S o N l I N E :
`
`editorial
`THe eLeMenTS
`OF SUcceSS
`
`By Peter J. McDonnell, MD
`
`The country of Brazil has changed dra-
`
`matically in the past two decades. After
`
`emerging from a military government,
`
`successive democratically elected gov-
`
`ernments have overseen dramatic eco-
`
`nomic growth—Brazil is 5th or 6th in
`
`terms of gross domestic product—with
`
`an unemployment rate lower than the
`
`United States, plus the emergence of
`
`an extremely large middle class. With
`
`this success comes greater demand
`
`for health-care services.
`
`My friend, Mauro, is an ophthalmolo-
`
`gist in the largest city (by population)
`
`in the Western Hemisphere.
`( See story on page 4 : Editorial )
`
`cataract
`
`3 STraTeGieS
`FOr TraUMaTic
`caTaracT
`
`D U r H a M , n c :: mAnAging trAu-
`
`mAtic cAtArActs in children requires
`
`attention to three issues when implant-
`
`ing an IOL: the timing of the implanta-
`
`tion, the lens type, and the IOL calcu-
`
`lations, said Edward G. Buckley MD.
`
`However, there are several controversies
`
`regarding IOL implantation in children.
`( See story on page 30 : Traumatic )
`
`SPECIAL REPOR T
`AdVANceS iN
`gLAucomA
`
`M yO P i c L a S i K wFg ABLATioNS
`+ POINT/COUNTERPOINT ‘IDEaL’ DME THEraPY
`
`SLT as standard for
`f rst-line IOP lowering
`
`Large retrospective
`analysis supports
`approach for
`reducing pressure
`with durable benef t
`By Cheryl Guttman Krader;
`Reviewed by Lawrence F. Jindra, MD
`
`nE W Yo rK ::
`the success oF selectiVe laseR
`
`trabeculoplasty (SLT) as a primary therapy for glau-
`coma is supported by a review of a large series of
`eyes with long-term follow-up.
`The analysis included data from 1,983 eyes identi-
`fied from a consecutive series of 4,048 eyes treated
`with SLT over a period of 10 years. Suggested prac-
`tice guidelines were used from the American Acad-
`emy of Ophthalmology, the Glaucoma Laser Trial,
`the Ocular Hypertension Treatment Study (OHTS),
`and the Early Management of Glaucoma Trial.
`All patients had a minimum follow-up of 2 months.
`Average follow-up for the 1,983 eyes was 917 days.
`Mean IOP was 18.1 mm Hg prior to SLT, and it
`decreased to 12.8 mm Hg (–29%) at last follow-up.
`
`( Continues on page 21 : SLT)
`
` Applications for SLT therapy
`Selective laser trabeculoplasty (SLT) is
`
`a highly effective approach for first-line
`
`glaucoma therapy. It is also effective
`
`as adjunct therapy with drugs, and
`
`as alternative therapy when drugs or
`
`surgery fail. Most importantly, SLT
`
`enables ophthalmologists to manage
`
`patients’ glaucoma treatment without
`
`the compliance issues and side effects
`
`associated with drug therapy.
`
`(Figure courtesy of Ellex)
`
`
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`ES316824_OT090113_CV1.pgs 09.06.2013 01:55 ADV
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`Page 1 of 40
`
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`ES312045_OT090113_CV2_FP.pgs 08.29.2013 23:37 ADV
`
`slt-ellex.com/USA
`
`Page 2 of 40
`
`
`
`September 1, 2013 :: ophthalmology times
`
`contents
`contents
`
`3
`
`28
`
`8
`
`16
`
`22
`
`surgical tEchniquE
`
`Neuro-Ophthalmology
`
`Cataract
`
`24 tracking visual loss
`in multiPle sclerosis
`Time-domain OCT used to determine
`if thinning of RNFL continued
`
`30 3 strategies for
`traumatic cataract
`Timing, IOL type, and lens calculations
`are important for pediatrics
`
`Retina
`
`Refractive
`
`28 Point: laser treatment
`necessary for dme
`Subthreshold micropulse laser preferred
`over conventional laser
`
`32 hoW Wfg ablations
`comPare
`No clear patient preference for wavefront-
`guided excimer lasers for myopic LASIK
`
`29 counterPoint: factors
`limit subthreshold
`laser
`Why laser treatment currently not an
`important therapeutic modality
`
`Practice Management
`
`37 taking one for the team
`When putting others before self
`for the good of the group can have
`meaningful outcomes
`
`Special Report
`Glaucoma
`
` 8 a non-invasive look at
`trabecular meshWork
`How novel OCT platform detects motion,
`may advance glaucoma research
`
`11 controlling circadian
`ioP fluctuation
`Neurons may offer novel glaucoma
`therapeutic target, animal study shows
`
`19 When fixed-combination
`is viable oPtion
`Brinzolamide-brimonidine may beneft
`patients who have contraindications
`to beta-blocker
`
`In Every Issue
`
`4 E d i t o r i a l 6 o p h t h a l m i c n E w s 3 4 m a r k E t p l ac E
`
`
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`ES316820_OT090113_003.pgs 09.06.2013 01:43 ADV
`
`Page 3 of 40
`
`
`
`4
`
`editorial
`editorial
`
`The elements of success
`
`Technology may be important, but employees are the real key
`
`hospital. He has a formal orientation program
`to train employees as they join, and continuing
`education for everyone. Every employee is to
`have a career plan within the organization.
`The educational programs are intended not
`simply to enhance the skill level of employees,
`but also to help them feel that they are engag-
`ing in personal development.
`“Our goal is not to get them to perform a lit-
`tle better, but to encourage critical thinking
`and problem solving,” he said.
`Educational programs must have excellent
`trainers, mix employees from different areas of
`the hospital, be less than 2 hours in length, and
`be formally assessed and improved with time.
`Trainers are required to make sure their ses-
`sions are informative, interesting, and partici-
`patory. Teamwork is emphasized.
`Mauro regularly measures employee satisfac-
`tion to determine the effectiveness of various
`employee development and retention initiatives.
`In his research of the literature, he finds that
`an overall satisfaction score of 45% is consid-
`ered quite high, and his hospital has exceeded
`this with a score of 65%.
`Also, he has found that employee satisfaction
`scores are correlated with age. Employees aged
`fewer than 30 years consistently report lower
`satisfaction scores than do older workers.
`In the largest country of South America, as
`in the largest of North America, there is the be-
`lief that younger people—and younger physi-
`cians—have a different approach to work and
`work-life balance. People in Mauro’s position
`must recognize and respond to that reality.
`
`L E S S O N S T O L E A R N
`
`What can we ophthalmologists in the wealthiest
`country in the Western Hemisphere learn from
`the success of ophthalmic institutions in other
`countries with different cultures, histories, and
`degrees of wealth? A great deal, I believe.
`As downward pressure on health-care reim-
`bursement continues in the United States, the
`institutions that survive and thrive will be the
`ones that adopt many of Mauro’s strategies. ■
`
`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: pmcdonn1@jhmi.edu
`
`“I am not led. I lead.”
`—Motto of the city of São Paulo, Brazil
`
`THE COUNTRY OF BRAZIL has
`changed dramatically in the past two decades.
`After emerging from a military government,
`successive democratically elected governments
`have overseen dramatic economic growth—Bra-
`zil is 5th or 6th in terms of gross domestic prod-
`uct—with an unemployment rate lower than
`the United States, plus the emergence of an ex-
`tremely large middle class. With this success
`comes greater demand for health-care services.
`My friend, Mauro, is an ophthalmologist in the
`largest city (by population) in the Western Hemi-
`sphere. In 2010, he opened the first large eye hos-
`pital in this city of 16 million-plus people. By all
`measures, this hospital has been a great success.
`From 2010 to 2012, surgeries increased by
`68%, emergency referrals by 600%, routine
`exams by 376%, and ophthalmologists using
`the hospital grew from 13 in 2010 to 198 in
`2012. Any eye hospital in the United States
`would be delighted with such numbers.
`Among Mauro’s elements of success:
`> Assembly-line efficiency
`
`> Strict quality norms
`
`> Brand recognition
`
`> Standardization
`
`> Consistency
`
`> Ruthless cost control
`
`> Economies of scale that accompany high volume
`“What is the key element that explains your
`success?” I asked my friend.
`“Having the best technology is important,” he
`said, “but the real key is having the best people.”
`
`I N V E S T I N G I N E M P L O Y E E S
`
`Mauro has devoted a lot of attention to attract-
`ing and retaining the best employees for his
`
`SEPTEMBER 1, 2013 :: Ophthalmology Times
`
`SEPTEMBER 1, 2013 ◾ VOL. 38, NO. 17
`
`C O N T E N T
`
`Chief Medical Editor Peter J. McDonnell, MD
`Group Content Director Mark L. Dlugoss
`mdlugoss@advanstar.com 440/891-2703
`Content Channel Director Sheryl Stevenson
`sstevenson@advanstar.com 440/891-2625
`Content Specialist Rose Schneider
`rschneider@advanstar.com 440/891-2707
`Digital & Interactive Content Manager Brandon Glenn
`Group Art Director Robert McGarr
`Art Director Nicole Davis-Slocum
`Anterior Segment Techniques Ernest W. Kornmehl, MD
`Cataract Corner Richard S. Hoffman, MD and Mark Packer, MD
`coding.doc L. Neal Freeman, MD, MBA
`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
`
`P U B L I S H I N G / A D V E R T I S I N G
`
`Executive Vice President Georgiann DeCenzo
`gdecenzo@advanstar.com 440/891-2778
`VP, Group Publisher Ken Sylvia
`ksylvia@advanstar.com 732/346-3017
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`lavila@advanstar.com 302/239-5665
`Associate Publisher Erin Schlussel
`eschlussel@advanstar.com 215/886-3804
`National Account Manager Rebecca A. Hussain
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`Account Manager, Classif ed/
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`Reprints 877-652-5295 ext. 121 / bkolb@wrightsmedia.com
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`ES312518_OT090113_004.pgs 08.30.2013 02:13 ADV
`
`Page 4 of 40
`
`
`
`September 1, 2013 :: Ophthalmology Times
`
`editorial advisory board
`editorial advisory board
`
`5
`
`Editorial advisory Board
`
`Ophthalmology Times Mission Statement
`
`Official publication sponsor of
`
`Chief Medical Editor
`Peter J. McDonnell, MD
`Wilmer Eye Institute
`Johns Hopkins University
`Baltimore, MD
`
`Associate Medical Editors
`Dimitri Azar, MD
`University of Illinois, Chicago
`Chicago, IL
`
`Anne L. Coleman, MD
`Jules Stein Eye Institute, UCLA
`Los Angeles, CA
`
`Ernest W. Kornmehl, MD
`Harvard & Tufts Universities
`Boston, MA
`
`Robert K. Maloney, MD
`Los Angeles, CA
`
`Joan Miller, MD
`Massachusetts Eye & Ear Infirmary
`Harvard University
`Boston, MA
`
`Randall Olson, MD
`University of Utah
`Salt Lake City, UT
`
`Robert Osher, MD
`University of Cincinnati
`Cincinnati, OH
`
`Ophthalmology Times is a physician-driven publication that disseminates news and information of
`a clinical, socioeconomic, and political nature in a timely and accurate manner for members of the
`ophthalmic community.
`
`In partnership with our readers, we will achieve mutual success by:
`◾ Being a forum for ophthalmologists to communicate their clinical knowledge, insights, and discoveries.
`
`◾ Providing management information that allows ophthalmologists to improve and expand their practices.
`
`◾ Addressing political and socioeconomic issues that may either assist or hinder the ophthalmic
`community, and reporting those issues and their potential outcomes to our readers.
`
`Anterior Segment/Cataract
`Cornea/External Disease
`
`Ashley Behrens, MD
`Wilmer Eye Institute, Johns Hopkins University
`Baltimore, MD
`
`Rubens Belfort Jr., MD
`Federal University of São Paulo
`São Paulo, Brazil
`
`Elizabeth A. Davis, MD
`University of Minnesota,
`Minneapolis, MN
`
`Uday Devgan, MD
`Jules Stein Eye Institute,UCLA
`Los Angeles, CA
`
`Richard S. Hoffman, MD
`Oregon Health & Science University
`Portland, OR
`
`Samuel Masket, MD
`Jules Stein Eye Institute,UCLA
`Los Angeles, CA
`
`Bartly J. Mondino, MD
`Jules Stein Eye Institute,UCLA
`Los Angeles, CA
`
`Mark Packer, MD
`Oregon Health & Science University
`Portland, OR
`
`Michael Raizman, MD
`Massachusetts Eye & Ear, Harvard University
`Boston, MA
`
`Michael Snyder, MD
`Cincinnati Eye Institute
`Cincinnati, OH
`
`Walter J. Stark, MD
`Wilmer Eye Institute, Johns Hopkins University
`Baltimore, MD
`
`Robert Ritch, MD
`New York Eye & Ear Infirmary
`New York, NY
`
`Joel Schuman, MD
`University of Pittsburgh Medical Center
`Pittsburgh, PA
`
`Kuldev Singh, MD
`Stanford University
`Stanford, CA
`
`Robert N. Weinreb, MD
`Hamilton Glaucoma Center
`University of California, San Diego
`
`Neuro-Ophthalmology
`
`Andrew G. Lee, MD
`Methodist Hospital, Texas Medical Center
`Houston, TX
`
`Oculoplastics/
`Reconstructive Surgery
`
`Robert Goldberg, MD
`Jules Stein Eye Institute, UCLA
`Los Angeles, CA
`
`John T. LiVecchi, MD
`St. Luke’s Cataract & Laser Institute
`Tarpon Springs, FL
`
`Shannath L. Merbs, MD
`Wilmer Eye Institute, Johns Hopkins University
`Baltimore, MD
`
`Pediatric Ophthalmology
`
`Norman B. Medow, MD
`Albert Einstein College of Medicine
`Bronx, NY
`
`Jennifer Simpson, MD
`University of California, Irvine
`Irvine, CA
`
`Peter S. Hersh, MD
`University of Medicine & Dentistry of New Jersey
`Newark, NJ
`
`Jonathan H. Talamo, MD
`Harvard University
`Boston, MA
`
`Kazuo Tsubota, MD
`Keio University School of Medicine
`Tokyo, Japan
`
`Retina/Vitreous
`
`Stanley Chang, MD
`Columbia University
`New York, NY
`
`David Chow, MD
`University of Toronto
`Toronto, Canada
`
`Pravin U. Dugel, MD
`Phoenix, AZ
`
`Sharon Fekrat, MD
`Duke University
`Durham, NC
`
`Julia Haller, MD
`Wills Eye Institute, Thomas Jefferson University
`Philadelphia, PA
`
`Tarek S. Hassan, MD
`Oakland University
`Rochester, MI
`
`Michael Ip, MD
`University of Wisconsin
`Madison, WI
`
`Carmen A. Puliafito, MD
`Keck School of Medicine, USC
`Los Angeles, CA
`
`Carl D. Regillo, MD
`Wills Eye Institute, Thomas Jefferson University
`Philadelphia, PA
`
`Rhein Fire & Ice Mask
`Aids In Reducing Dry Eye Symptoms
`
`H. Jay Wisnicki, MD
`New York Eye & Ear Infirmary, Beth Israel Medical
`Center, Albert Einstein College of Medicine
`New York, NY
`
`Lawrence J. Singerman, MD
`Case Western Reserve University
`Cleveland, OH
`
`Farrell “Toby” Tyson, MD
`Cape Coral, FL
`
`Glaucoma
`
`Robert D. Fechtner, MD
`University of Medicine & Dentistry of New Jersey
`Newark, NJ
`
`Neeru Gupta, MD
`University of Toronto
`Toronto, Canada
`
`Malik Kahook, MD
`University of Colorado,Denver
`Denver, CO
`
`Practice Management
`
`Joseph C. Noreika, MD
`Medina, OH
`
`Frank Weinstock, MD
`Boca Raton, FL
`
`Refractive Surgery
`
`Uveitis
`
`Emmett T. Cunningham Jr., MD, PhD
`Stanford University
`Stanford, CA
`
`Chief Medical Editors-
`Emeritus
`
`Jack M. Dodick, MD
`New York University School of Medicine
`New York, NY (1976-1996)
`
`David R. Guyer, MD
`New York, NY (1996-2004)
`
`Richard K. Parrish II, MD
`Bascom Palmer Eye Institute, University of Miami
`Miami, FL
`
`William Culbertson, MD
`Bascom Palmer Eye Institute, University of Miami
`Miami, FL
`
`Harry A. Quigley, MD
`Wilmer Eye Institute, Johns Hopkins University
`Baltimore, MD
`
`Kenneth A. Greenberg, MD
`Danbury Hospital
`Danbury, CT
`New York University
`New York, NY
`
`Ophthalmology Times Industry Council
`
`John Bee
`Rhein Medical Inc.
`President and CEO
`
`William Burnham, OD
`Carl Zeiss Meditec Inc.
`Director of Market Development, Americas
`
`Alastair Douglas
`Alcon Laboratories Inc.
`Director of U.S. Commercial Support
`
`Bob Gibson
`Topcon Medical Systems Inc.
`Vice President of Marketing
`
`Marc Gleeson
`Allergan Inc.
`Vice President, U.S. Eye Care Pharmaceuticals
`Glaucoma and External Disease Marketing
`
`Mark Newkirk
`Reichert Technologies
`Director of Global Marketing and Sales
`
`Ram Palanki
`ThromboGenics Inc.
`Global Head – Marketing and Sales
`
`Daina Schmidt
`Bausch + Lomb Surgical
`Global Executive Director of Product Strategy
`
`Kelly Smoyer
`Essilor of America
`Product Director
`
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`Genentech USA Inc.
`Vice President, Sales and Marketing
`
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`ES312519_OT090113_005.pgs 08.30.2013 02:13 ADV
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`Page 5 of 40
`
`
`
`6
`
`ophthalmic news
`ophthalmic news
`
`( In Brief )
`
`In memoriam
`
`GLAUCOMA RESEARCHER
`DR. BERNARD BECKER DIES
`
`S T. L OUIS :: BERNARD BECKER, MD, chairman
`of the ophthalmology department at the Wash-
`
`ington University School of Medicine in St. Louis
`
`for 35 years, has died.
`
`Dr. Becker, 93, passed away Aug. 28 at his
`
`home in St. Louis after a battle
`
`with lung cancer.
`
`Washington University is planning a memorial
`
`service for Dr. Becker, who donated his body to
`
`the university’s school of medicine.
`
`Af ibercept indication
`
`REGENERON INJECTION GAINS
`EUROPEAN APPROVAL
`
`TARR Y TOWN, N Y :: REGENERON PHARMACEUTI-
`CALS’ new treatment for visual impairment due
`to macular edema secondary to central retinal
`
`SEPTEMBER 1, 2013 :: Ophthalmology Times
`
`HEADLINES YOU
`MIGHT HAVE MISSED
`
`AS SEEN IN Ophthalmology Times’ weekly
`eReport. Sign up at http://www.modernmedicine.
`
`com/OphthalmologyTimes/enewssignup
`
`CMS CLEARS RETINAL
`PROSTHESIS SYSTEM
`SECOND SIGHT MEDICAL PRODUCTS’ retinal
`prosthesis system has been approved by the
`
`Centers for Medicare and Medicaid Services
`
`Dr. Becker was known for dis-
`
`vein occlusion (CRVO) has been approved by the
`
`for both inpatient and outpatient settings of
`
`covering one of the first treatments
`
`European Commission.
`
`care payments beginning Oct. 1.
`
`for glaucoma—a drug called acet-
`
`Aflibercept (Eylea) was approved in the United
`
`http://bit.ly/14gaM8H
`
`azolamide used to decrease pres-
`
`States for the treatment of neovascular (wet) age-
`
`sure in the brain. He determined
`
`related macular degeneration (AMD) in 2011, and
`
`Dr. Becker
`
`the drug could also be used to
`
`for macular edema following CRVO in 2012.
`
`decrease pressure in the eyes.
`
`“We are pleased with the approval of (afliber-
`
`From 1953 to 1988, Dr. Becker helped Wash-
`
`cept) in the European Union in a second indication,”
`
`ington University build its Department of Ophthal-
`
`said George D. Yancopoulos, MD, PhD, chief scien-
`
`mology and Visual Arts. He was also one of the
`
`tific officer of Regeneron and president of Regen-
`
`founders of the Association for Research in Vision
`
`eron Laboratories. “Our phase III studies showed
`
`and Ophthalmology, and helped establish the Na-
`
`that (aflibercept) improved visual outcomes signifi-
`
`tional Eye Institute.
`
`INSITE VISION EARNS
`PATENT ISSUANCE
`INSITE VISION INC.’S DRUG DELIVERY SYS-
`TEM has received a patent from the U.S. Patent
`and Trademark Office. The patent will provide
`
`utility-composition of matter protection until
`
`2029 for InSite Vision’s DuraSite 2 for both its
`
`cantly. . . . This additional approval of (aflibercept)
`
`In 1995, Washington University renamed its
`
`is great news for patients in Europe.”
`
`medical library in his honor.
`
`Aflibercept has also been approved in Europe,
`
`Dr. Becker grew up in Brooklyn, NY, and gradu-
`
`Japan, Australia, and in several other countries
`
`ated from Princeton University and Harvard Medi-
`
`for use in wet AMD and in selected countries in
`
`cal School. He was also an army psychiatrist dur-
`
`South American for macular edema following CRVO.
`
`ing World War II.
`
`Following the war, Dr. Becker trained in ophthal-
`
`mology at Johns Hopkins University.
`
`Dr. Becker has received many awards, including
`
`the American Academy of Ophthalmology’s high-
`
`est honor. He has also co-written the first two edi-
`
`tions of “Diagnosis and Therapy of the Glaucomas.”
`
`CLARIFICATION The f rst installment of the new
`“Gloves Off with Gulani” series will begin in the
`Oct. 1 issue of Ophthalmology Times. Missed the
`series introduction? Go to http://bit.ly/15memRo.
`
`delivery system and drugs.
`
`http://bit.ly/1anYtLa
`
`VMA TREATMENT
`OK’D IN CANADA
`HEALTH CANADA HAS CLEARED Thrombo-
`Genics NV’s treatment for symptomatic vitreo-
`
`macular adhesion. Canada is now the first mar-
`
`ket where ocriplasmin (Jetrea) is approved out-
`
`side the United States and Europe.
`
`http://bit.ly/12lU5r8
`
`Photo of Dr. Becker courtesy of the American Academy of Ophthalmology
`
`On Twitter
`
`Digital App
`
`Recent hashtags Ophthalmology Times
`
`Introducing the
`
`has used on twitter.com/OphthTimes
`
`Ophthalmology Times
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`#ophthalmology
`
`#eyehealth
`
`#eyecare
`
`#astigmatism
`
`#retina
`
`#AMD
`
`#myopia
`
`#cataract
`
`#dryeye
`
`#dispensing
`
`#optical
`
`#AMD
`
`app for iPad and
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`iPhone. Download
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`it for free today at
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`Video
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`See how an
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`used in place of
`a traditional slit
`lamp camera.
`Go to http://bit.
`ly/15mzBCL
`
`
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`
`
`THE 1960s CALLED.
`
`THEY WANT THEIR
`
`FILTRATION SURGERY BACK.
`
`It’s time for a change.
`
`Discover Lumenal Control. The EX-PRESS® Glaucoma Filtration
`Device eliminates one of the most critical surgical variables.
`By standardizing the lumenal structure through which aqueous
`humor fl ows, you get consistent, predictable fi ltration.
`
`© 2013 Novartis 7/13 EXP13042JADD MyAlcon.com
`
`CAUTION: Federal law restricts this device to sale by or on the order of a physician.
`INDICATION: The EX-PRESS® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.
`GUIDANCE REGARDING THE SELECTION OF THE APPROPRIATE VERSION: Prior clinical studies were not designed to compare between the various versions of the EX-PRESS® Glaucoma Filtration Device.
`The selection of the appropriate version is according to the doctor’s discretion.
`CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist:
`• Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis.
`• Pre-existing ocular or systemic pathology that, in the opinion of the surgeon, is likely to cause postoperative complications following implantation of the device.
`• Patients diagnosed with angle closure glaucoma.
`WARNINGS/PRECAUTIONS:
`• The surgeon should be familiar with the instructions for use.
`• The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised.
`• This device is for single use only.
`• MRI of the head is permitted, however not recommended, in the fi rst two weeks post implantation.
`ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings, precautions, complications and adverse events.
`
`
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`ES312056_OT090113_007_FP.pgs 08.29.2013 23:37 ADV
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`Page 7 of 40
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`
`
`8
`
`Special Report )
`
`Glaucoma
`
`AdvANces coNtiNue to progress for the treAtmeNt ANd mANAgemeNt of glAucomA
`
`tm movement necessary to account for aqueous outfow?
`
`2 μl/min ÷ 60 bpm = 0.03 μl/sec
`
` ~0.03 µl Volume
`each Heartbeat
`
`~350 µm A-P
`
`38 mm Circumference
`
`SC ~38 mm
`Circumference
`
`SC A-P Length
`~350 μm
`
` ~2.7 µm
`TM Movement
`each Heartbeat
`
`A NoN-iNvAsive look
`At trAbeculAr
`meshwork
`How novel OCT platform detects and measures motion,
`may advance glaucoma research and patient care
`By Cheryl Guttman Krader; Reviewed by Murray Johnstone, MD
`
`S e at t l e ::
`
`raphy (PhS-OCT) for in vivo evalua-
`
`take-home
`
` An investigational
`
`non-invasive imaging
`
`tool—phase-sensitive
`
`optical coherence
`
`tomography—can be
`
`used to detect and
`
`measure movement
`
`of the trabecular
`
`meshwork in vivo.
`
`(Figure 1) Aqueous outfow from Schlemm’s
`canal (SC) is pulsatile, being dependent
`on trabecular meshwork (TM) motion with
`optical coherence tomography measurements
`indicating the TM motion is adequate to
`account for all of aqueous outfow. (A-P is
`anterior-posterior SC length. (Figure courtesy
`of Murray Johnstone, MD)
`
`sue movement correlated to a simulated car-
`diac pulse with amplitude trabecular motion
`sufficient to account for aqueous outflow.
`
`E x a m i n i n G t h E h u m a n s t u dy
`
`A second study using PhS-OCT was then con-
`ducted in 10 human adults to investigate pulse-
`induced trabecular meshwork motion, said Dr.
`Johnstone, clinical professor of ophthalmology,
`University of Washington.
`As in the animal study,
`PhS-OCT was highly sensi-
`tive for detecting trabecular
`meshwork motion.
`Analyses of the trabecu-
`lar meshwork tissue motion
`wave, in relation to the digi-
`tal pulsimetry wave, showed
`a high correlation between
`trabecular meshwork wave minima and digital
`pulse peaks. The research also showed PhS-
`OCT could be used to measure velocity of the
`trabecular meshwork motion and the strain rate.
`“This technology opens a new window into
`understanding abnormalities of trabecular mesh-
`work biomechanics leading to glaucoma,” Dr.
`Johnstone said. “It will eventually revolution-
`ize our approaches to glaucoma management.”
`
`Dr. Johnstone
`
`E v a l u a t i n G n E E d f o r
`t r a B E C u l a r m E s h w o r K
`
`Interest in developing technology for evaluat-
`ing trabecular meshwork motion derives from
`revised concepts about aqueous outflow and
`resistance.
`Whereas initial work by Morton Grant, MD,
`posited that the trabecular meshwork acted as
`a rigid, restrictive filter creating resistance,
`additional research demonstrated that the
`tissue was highly compliant. This indicated
`that movement of the trabecular meshwork
`becomes appositional with the external wall
`of Schlemm’s canal and represented the most
`important source of resistance.
`Findings from histological studies provided
`support for this concept, but direct evidence of
`trabecular meshwork motion in vivo was lack-
`ing until the development of PhS-OCT.
`Continues on page 15 : Non-invasive
`
`P hase-sensitive optical coherence tomog-
`
`tion is a promising tool for advancing
`
`glaucoma research and patient care,
`
`according to findings from a human study presented
`
`by Murray Johnstone, MD.
`The investigational device—developed by Ruikang Wang, PhD,
`professor of bioengineering, University of Washington, Seattle—
`has resolution at the nanometer scale and moves OCT technology,
`which is limited to structural imaging, to a new realm involving
`characterization of motion and function.
`PhS-OCT was highly sensitive for detecting trabecular mesh-
`work motion, according to results of an initial laboratory study
`involving enucleated primate eyes. The study also showed the tis-
`
`
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`ES316326_OT090113_008.pgs 09.05.2013 01:59 ADV
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`Page 8 of 40
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`ES315118_OT090113_009_FP.pgs 08.31.2013 04:21 ADV
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`Page 9 of 40
`
`
`
`LUMIGAN® 0.01% AND 0.03%
`(bimatoprost ophthalmic solution)
`
`Brief Summary—Please see the LUMIGAN® 0.01% and 0.03% package
`insert for full Prescribing Information.
`INDICATIONS AND USAGE
`LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) is indicated for the
`reduction of elevated intraocular pressure in patients with open angle glaucoma or
`ocular hypertension.
`
`CONTRAINDICATIONS
`None
`
`WARNINGS AND PRECAUTIONS
`Pigmentation: Bimatoprost ophthalmic solution has been reported to cause changes
`to pigmented tissues. The most frequently reported changes have been increased
`pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is
`expected to increase as long as bimatoprost is administered. The pigmentation
`change is due to increased melanin content in the melanocytes rather than to
`an increase in the number of melanocytes. After discontinuation of bimatoprost,
`pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital
`tissue and eyelash changes have been reported to be reversible in some patients.
`Patients who receive treatment should be informed of the possibility of increased
`pigmentation. The long term effects of increased pigmentation are not known.
`Iris color change may not be noticeable for several months to years. Typically, the
`brown pigmentation around the pupil spreads concentrically towards the periphery
`of the iris and the entire iris or parts of the iris become more brownish. Neither nevi
`nor freckles of the iris appear to be affected by treatment. While treatment with
`LUMIGAN® 0.01% and