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Committee seeks understanding of post-LASIK keratectasia
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WAILEA, Hawaii — Many ophthalmologists are unclear regarding what is known and what is not known about post-LASIK keratectasia, and a committee is working to establish a better understanding of the condition through an evidence-based approach, according to a speaker here.
In a presentation at Hawaiian Eye 2006, Helen K. Wu, MD, described recent efforts by an ad hoc committee to address this gray area in ophthalmology. She and other prominent refractive surgeons are members of the committee, which is headed by Perry Binder, MD, and Richard L. Lindstrom, MD.
The committee began its work, she said, after the now infamous case in which a New York jury awarded $7.25 million – the largest award to date – to a LASIK patient who claims he suffered severe vision damage from the surgery.
“[Following that verdict] it became clear that there was an extreme difference in opinion regarding the extent of knowledge about keratectasia, specifically about what the established risk factors are and when they became the standard of care,” Dr. Wu said.
![Helen K. Wu, MD [photo]](/images\OSN\200602b\wu.jpg) Helen K. Wu |
She said she and her fellow committee members will seek to establish what is known about iatrogenic corneal ectasia – the incidence of which is unknown – and to create a registry of cases induced by LASIK or PRK, “in an attempt to provide an evidence-based approach.”
The group recently published a consensus opinion to summarize current knowledge about corneal ectasia. The paper was published simultaneously in the November/December issue of the Journal of Refractive Surgery and the November issue of the Journal of Cataract and Refractive Surgery.
Committee members also plan to address the matter at upcoming meetings, including a Hot Topics symposium at the American Society of Cataract and Refractive Surgery meeting in March, Dr. Wu said.
While corneal ectasia is rare, there are several known risk factors for its occurrence after LASIK, including high myopia, a deep ablation, an unexpectedly thick flap, low residual stromal bed thickness and abnormal corneal topography, Dr. Wu said. Cases can also develop in the absence of surgery or any risk factors, although these are much less frequent.
More presentations from Hawaiian Eye 2006 are highlighted in the remainder of this article. Many of these items appeared first on OSNSuperSite.com as daily reports from the meeting.
Refractive Surgery
Adding phakic IOLs to practice can spur growth
With proper planning, phakic IOLs can be profitably and seamlessly added to any surgeon’s comprehensive refractive surgery practice, according to David Hardten, MD. He said phakic IOLs have been a “tremendous growth area” in his practice.
Two phakic IOL models have been approved by the Food and Drug Administration. The Verisyse IOL is currently available through Advanced Medical Optics in the United States, and the recently approved STAAR Surgical Visian ICL is expected to be available later this year.
Dr. Hardten said the advantages of phakic IOLs include their ability to address higher refractive errors and their easily learned implantation techniques. He said phakic IOLs offer retention of accommodation, removability, excellent visual results and a low risk of complications.
While he acknowledged that phakic IOL implantation is a relatively low-volume procedure, Dr. Hardten said the highly myopic patients who are candidates for this refractive surgical option are “energetic ambassadors.”
“When they are happy, they are really happy. If you come to be known as someone who helps these highly disabled patients in your community, that is really good word of mouth,” he said.
To optimize efficiency when introducing phakic IOLs to a practice, the surgeon must plan training sessions for all technical and support staff, Dr. Hardten said. Documents such as consent forms and postoperative instructions should be prepared in advance, he said.
For cataract or refractive surgeons, phakic IOL procedures can easily be incorporated into the scheduling flow, he said. His clinic schedules these procedures just as they do a cataract removal, and he typically staggers them, with one phakic IOL procedure following every three cataract procedures.
For a surgeon’s first cases, Dr. Hardten recommends choosing young patients with about 12 D of myopia and reasonable expectations.
Dr. Hardten said because of the relatively low volume there is a low yield on marketing this procedure. He said surgeons should let their happy patients be their marketers.
“I have found [the promotion of phakic IOLs] to be very synergistic with an overall refractive surgery marketing plan,” he said.
Surface ablation to enhance LASIK
Surface ablation techniques can be used to enhance the results of previous LASIK, particularly when the condition of the cornea complicates lifting the flap, according to William B. Trattler, MD.
Dr. Trattler said PRK or laser epithelial keratomileusis may be indicated as enhancement techniques for post-LASIK patients with certain corneal conditions. These conditions can include an insufficient residual stromal bed; consecutive hyperopia after primary myopic LASIK; intraoperative or postoperative flap problems; flaps that are difficult to lift because too much time has gone by since the LASIK procedure; and severe dry eye syndrome.
Dr. Trattler reported on a retrospective study of 89 eyes treated with either PRK or LASEK to enhance previous LASIK. He and colleagues found that “there was a strong trend toward improvement in [best corrected visual acuity]” following the surface ablation procedures. Nearly 100% of the eyes attained 20/40 or better uncorrected visual acuity. And there were no cases of postoperative corneal haze, which can be a major concern after surface ablation, Dr. Trattler said.
He said he believes that there are three keys to success with surface ablation: promoting rapid visual recovery, preventing corneal haze, and minimizing postoperative pain and discomfort.
Surgeons can reduce the risk of postop haze by applying mitomycin-C 0.02% to the cornea after the ablation, Dr. Trattler said. To minimize pain and maximize patient comfort, a careful preoperative dry eye test is essential to determine if the patient should be treated prophylactically with Restasis (cyclosporine, Allergan) and punctal plugs, he said.
Other methods of reducing postop pain include prescribing oral and/or topical nonsteroidal anti-inflammatory drugs, chilling the cornea and using bandage contact lenses, Dr. Trattler said.
Photographer relates his ‘vision’ in life | ||
WAILEA, Hawaii – National Geographic photojournalist Dewitt Jones encouraged attendees at Hawaiian Eye 2006 to create their own vision. “You need to create a vision that is possible if you just have the courage to manifest it,” Mr. Jones said in his keynote speech. As he spoke about his experiences, he said finding solutions to problems early in his life helped him to see situations in different lights. When shooting pictures, he used those early experiences to help him look for better solutions, different perspectives. “I needed to take a perspective that would transform the ordinary into the extraordinary,” he said. To develop better vision, Mr. Jones said, people must “train” their technique. “Vision without technique is blind. You need to put yourself in the place with the most potential. Open yourself to possibilities that you have never dreamed of,” he said. People must focus on “celebrating what is right,” he said. “It is not about finding the right answer, but continuously finding the next right answer.” Known as one of America’s top professional photographers, Mr. Jones has traveled as a National Geographic freelance photojournalist for 20 years. Among his honors are two Academy Award nominations, which he received before age 30, for his films “John Muir’s High Sierra” and “Climb.” Mr. Jones’s creativity has expanded into writing, and has nine published books, including California! A Vision of Wilderness, Robert Frost – A Tribute to the Source and The Nature of Leadership, and his monthly column in Outdoor Photographer magazine. In the advertising world, Mr. Jones has contributed to national ad campaigns for Dewar’s Scotch, Canon and United Airlines. |
![Dewitt Jones [photo]](/images\OSN\200602b\jones.jpg)
Personalized nomogram improves custom ablation
Refractive surgeons can optimize their LASIK results and avoid systematic errors in their patients by adopting a personalized nomogram for custom ablation, according to Yunhee Lee, MD.
Dr. Lee explained that even two surgeons with nearly identical surgical styles, using the same laser in the same laser suite, will have slightly different outcomes when using the same nomogram.
Dr. Lee and colleagues used regression analysis to analyze the results of conventional vs. customized LASIK, as well the results of customized LASIK performed by two surgeons using the same nomogram.
Graphed on a scatterplot, the outcomes of the two surgeons – both using the same customized laser platform, staff, laser suite and technical style – differed by approximately 0.75 D, she said.
“Indeed, the slopes of these scatter- plots are not identical [as we expected], but to differ by about 0.75 D underscore the need for personalized nomograms,” Dr. Lee said.
She recommended using one of the commercially available software packages for generating a personal nomogram, such as SPSS/SAS, Outcomes Analysis Software, Refractive Surgery Consultant 2000 or Refractive Surgery Consultant Elite.
In creating the personal nomogram, Dr. Lee suggested leaving out variables that are held constant from case to case, such as temperature and humidity, and choosing variables that change, such as age, gender, keratometry and IOP.
“Variables that are held constant from case to case will not alter your outcome and will be one more variable you don’t have to track and analyze,” Dr. Lee said. “Anything you change from case to case could potentially be important in your outcome.”
Above all, she stressed the need to keep the nomogram simple and consistent. She said it is important to “not change things on the fly or month to month based on how you think things are going.”
Creating a personal nomogram sooner rather than later is advisable, she said, “to avoid systematic errors in large groups of people.”
Visian ICL effective in hyperopia
The STAAR Visian ICL is a good choice for refractive surgical correction in hyperopic patients, according to Paul Dougherty, MD.
Dr. Dougherty said the Visian ICL, which is implanted behind the iris in phakic eyes, is his lens of choice for patients who are under 50 years old with at least 3 D of hyperopia.
“These are some of the happiest patients in my practice,” said Dr. Dougherty, a clinical investigator for the lens who has 3 years of follow-up on some patients.
Addressing the concern that the posterior chamber lens may cause cataracts, Dr. Dougherty said this has not been a significant problem in his experience, but he did say he has seen a small number of lens opacities in his patients.
“These are patients who you would think of doing refractive lensectomy on anyway, so typically the worst thing that can happen is very treatable,” he said.
Physicians demonstrate hobbies, from classical piano to magic | ||
WAILEA, Hawaii — In a session devoted to physicians’ interests outside the practice of ophthalmology, presenters here at Hawaiian Eye 2006 demonstrated and discussed their hobbies, which included scuba diving, stamp collecting, classical piano and magic. Carmen A. Puliafito, MD, MBA, co-course director of the meeting, revealed his in interest in philately, or stamp collecting. He said many people have been interested in philately. President Franklin D. Roosevelt was an avid stamp collector, especially after he became sick with polio. “Stamp collecting saved his life,” Dr. Puliafito said. Kenneth J. Rosenthal, MD, demonstrated his interest in classical piano by entertaining the audience with the Fantasie-Impromptu in C# minor, by Frederick Chopin, for which Dr. Rosenthal received a standing ovation. “Piano is a great adjunct for surgical skills,” Dr. Rosenthal said. “It allows you the ability to perform a number of simultaneous tasks. It also gives you physical dexterity and is a great form of relaxation and emotional expression.” Among other presenters at the session, Robert B. Miller, MD, said scuba diving “has made a profound impact on my life,” and Teruyuki Miyoshi, MD, performed a magic show that amused the audience. |
![Teruyuki Miyoshi, MD [photo]](/images\OSN\200602b\miyoshi.jpg)
Benefits of in-office surgical suites
Dr. Dougherty also spoke about the benefits of using an in-office surgical suite for some refractive surgical procedures.
He said transferring phakic IOL implantation and other refractive procedures into the office setting represents a “great and exciting practice enhancement.”
He said moving some refractive surgical procedures to an in-office surgical suite makes sense in terms of efficiency, time and finances, and several types of refractive surgery can be safely performed in that setting.
“I look at this similarly to the debate that went on 20 years ago about moving from the hospital to an outpatient center for intraocular surgery,” he said.
To make the transition, surgeons must adhere to federal guidelines – both physical and procedural – and “keep the focus on the quality of care,” Dr. Dougherty said.
He argued that surgeons are more comfortable in their own offices, have better control over their environments and can work with their own staff. Furthermore, patients are more comfortable because they see some of the same faces on the day of surgery as they have on previous appointments.
From a financial standpoint, the surgeon does not need to pay fees to an outside facility. Also, it is easier to fit in other appointments around the scheduled surgeries, Dr. Dougherty said.
He noted that most physical changes that must be made are minor; however, the surgeon must purchase all appropriate equipment, including a surgical chair, operating microscope, oral sedatives, a pulse oximeter and an EKG monitor.
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Dr. Dougherty said that getting the facility accredited is not technically necessary for some refractive procedures because insurance generally does not pay for refractive surgery. However, he recommended seeking accreditation from the Accreditation Association for Ambulatory Health Care if possible.
Finally, Dr. Dougherty said it is imperative to “notify your malpractice carrier in writing of what you are doing.”
Updated crystalens has square edge, new injector
The crystalens SE, a new version of the accommodating IOL, is designed to better prevent posterior capsular opacification, according to a surgeon who has used the new lens.
Dr. Lindstrom, OSN Chief Medical Editor, said the crystalens SE — for “square edge” — can be inserted through an incision of 2.8 mm to 3 mm.
During a presentation at the meeting, Dr. Lindstrom said the lens was designed with a 360· square edge, as opposed to the 240· of square edge in the original crystalens design. He said a squared optic edge has been shown to inhibit lens epithelial cell migration in other IOL models.
In an interview with Ocular Surgery News, he said no cycloplegia is necessary with the crystalens SE.
“You can use nothing, or your standard miotic, or whatever you would do in a standard eye,” he said.
A new injector for the lens reduces intraoperative time and provides a more sterile insertion “because the cartridge precludes the need for handling the lens directly,” he said.
IOLs in the pipeline
For several IOLs currently in development in the United States, “the story … is still unfolding,” according to I. Howard Fine, MD.
Dr. Fine said the IOLs in development employ a variety of new accommodative mechanisms, photochromic capabilities and other innovative characteristics.
In clinical trials of the Visiogen Synchrony dual-optic accommodating IOL, Dr. Fine said, 100% of 24 eyes had best corrected visual acuity of 20/40 or better at 6 months postoperative, according to data from Visiogen.
Another accommodating design, a deformable IOL from Power Vision, incorporates “new applied microfluidic technology in a single-piece IOL with a ‘dynamic optic,’” Dr. Fine said. When the lens is in place in the eye, microfluidic pumps “reversibly alter the radius of the curvature and effect an increase in IOL power for near vision,” he said.
Dr. Fine also discussed the LiquiLens from Vision Solution Technologies, yet another approach to pseudoaccommodation. Dr. Fine said this device “will provide emmetropia at distance and an accommodative mechanism that allows the lens to achieve three times and above magnification for near.” He said this lens, which is still in the prototype stage, functions based on gravity, and “is the only lens that functions in this way.”
Also under investigation is the Photochromatic Matrix IOL from Medennium. Dr. Fine said in dim-light conditions, this lens behaves like an ultraviolet-blocking IOL.
“Only in photopic conditions does it turn yellow and block blue light,” he said.
Cataract Surgery
Recognizing retinal complications of cataract surgery is first step in management
Cataract surgeons who learn to recognize signs of vitreous or retinal complications in their patients are “halfway home to solving the dilemma” for themselves, said Carmen A. Puliafito, MD, MBA.
Image: Stiglich JM, OSN |
![Carmen A. Puliafito, MD, MBA [photo]](/images\OSN\200602b\puliafito.jpg)
Dr. Puliafito delivered the keynote lecture “Management and prevention of cataract surgery complications: A vitreoretinal surgeon’s perspective” at the meeting.
“The first thing is to recognize complications. Not all of them are obvious,” Dr. Puliafito said. “If something seems [strange] to you, stop and ask yourself if the globe has been perforated.”
He noted that while complications sometimes have to do with technique, they can occur “even in the best of hands.”
Endophthalmitis, which is thought by some to be on the rise due to the adoption of clear corneal incision techniques, is still relatively rare, Dr. Puliafito said. Other risk factors may be responsible for the increased incidence of this complication following clear corneal cataract surgery, he said, such as compromised immunity, preoperative blepharitis and use of a lidocaine gel before povidone-iodine application.
Dr. Puliafito advised surgeons that if vitreous tap or vitrectomy is necessary, peribulbar anesthesia should be used. He also said antibiotics for intravitreal injection should be prepared ahead of time and stored in a refrigerator. Retained lens fragments can also complicate cataract surgery, he said, although he noted that fine pieces of cortex might be absorbed without the need for intervention. Risk factors for this complication include unrecognized hard nucleus, pseuodoexfoliation, previous vitreous surgery, the surgeon’s learning curve and patient movement.
For removal of a dislocated posterior chamber IOL, Dr. Puliafito said the surgeon should use a limbal or pars plana approach, and refixation of the IOL can be performed if circumstances permit.
One sure warning sign of a vitreoretinal complication is if the patient experiences a rise in IOP, Dr. Puliafito said.
“Once the patient demonstrates an IOP rise, that’s a sign you need to do something, and that the patient needs vitreoretinal intervention,” he said.
Patients also should be referred for vitreous surgery if there is a vitreous detachment or evidence of retinal incarceration.
‘HyperCruise’ system reduces energy delivery
A phacoemulsification system that combines technologies from several companies can allow surgeons to raise their vacuum levels, reduce energy delivery, increase overall safety and improve efficiency, according to one surgeon.
Elizabeth A. Davis, MD, said the use of this “HyperCruise” system has provided better patient outcomes.
Dr. Davis explained that the HyperCruise system combines the Bausch & Lomb Millennium Microsurgical System with venturi pump; the STAAR Surgical CruiseControl device; the Chop X1 phaco tip from MicroSurgical Technologies; and a Bausch & Lomb #D4600 air exchange line.
She said any phaco tip can be used, and still the maximum vacuum setting can be set at 400 mm Hg. The system has broad applicability, she said, and is “married best with venturi,” but it can also be used with a peristaltic pump.
Dr. Davis said that the STAAR CruiseControl device “prevents surge by increasing resistance and decreasing interior diameter” of the phaco tube lumen, which she said is beneficial during cataract surgery.
Using the Bausch & Lomb power module, she said, energy is conserved and heat is reduced. She uses a setting of 55 pulses per second at a 58% duty cycle.
Dr. Davis said she uses a flip technique for cataract surgery, which she found to be the safest. “You get far away from the capsular bag, and I have not broken a capsule in over a year,” she said.
She noted that the HyperCruise system can be used with other surgical techniques, including bimanual cataract surgery.
Glaucoma
Electronic tools may improve compliance
Image: Archer ME, OSN |
![Mildred M.G. Olivier, MD [photo]](/images\OSN\200602b\olivier.jpg)
Electronic devices and tools may help patients with glaucoma be more adherent to their medication regimens, said Mildred M.G. Olivier, MD.
D. Olivier said that electronic eye drop medication monitors currently being developed “may be the most reliable tool to measure compliance in glaucoma patients.”
“One of the most common reasons for patients not to be compliant is that they just forget to take their drops,” Dr. Olivier said.
She described two devices: one for use with Lumigan (bimatoprost, Allergan) and another for use with Travatan (travoprost, Alcon).
Both devices sound an alarm after 23 hours to remind patients that they need to take their drops again, Dr. Olivier said.
Innovations may reduce number of invasive procedures
Recent innovations in glaucoma surgery may lead to a reduction in the number of invasive procedures needed by glaucoma patients, said Richard A. Lewis, MD.
He provided an overview of recent technological developments in glaucoma surgery, including Optonol’s ExPress miniature glaucoma shunt, selective laser trabeculoplasty, endoscopic cyclophotocoagulation and the AquaFlow drainage device from STAAR Surgical.
Dr. Lewis said these recently developed procedures have reduced the occurrence of some early and late postoperative problems. With each of these procedures there is no bleb, and therefore there are “no bleb-related complications, and no hypotony,” he said.
However, Dr. Lewis said there are disadvantages to these procedures in comparison with trabeculectomy, including possibly insufficient pressure reduction.
“There is also a high learning curve associated with some of these newer procedures,” he said.
Army ophthalmologist returns from Iraq with tales of intense pressure | ||
WAILEA, Hawaii – After a 4-month tour of duty in Iraq, Scott D. Barnes, LTC, MC, USA, said his concept of what constitutes “pressure” has changed dramatically. Dr. Barnes described his experience serving as the only ophthalmologist at the 86th Combat Support Hospital in Baghdad here at Hawaiian Eye 2006. His story received a standing ovation. Dr. Barnes said he never knew what real pressure felt like until he was told by U.S. officials that an Iraqi patient who had sustained severe facial and ocular trauma had to regain his visual function because he was expected to be a main witness identifying important officials in Saddam Hussein’s toppled regime. It was not unusual for Dr. Barnes and the rest of the hospital staff – representing 23 subspecialties in all – to tend to Iraqi civilians and military alongside U.S. military personnel. But he said the most challenging days were when Iraqi detainees were brought in for treatment. “Imagine how interesting it was to have to take care of someone who only moments before had tried to shoot you or kill one of your soldiers,” Dr. Barnes said. A cornea specialist, Dr. Barnes said a typical day in Iraq found him doing procedures well beyond the scope of his training and experience at Fort Bragg, N.C. “Trauma care was different than what we had seen anywhere,” he said. |
![Scott D. Barnes, LTC, MC, USA [photo]](/images\OSN\200602b\barnes.jpg)
Cornea/external disease
Virologist: New antivirals needed in ophthalmic pipeline
Increased commitment from the ophthalmic pharmaceutical industry is needed to ensure the future availability of efficacious ophthalmic antiviral agents, according to an ophthalmic virologist.
Jerold S. Gordon, MD, said ocular viruses such as herpes simplex virus-1, herpes zoster, adenovirus and cytomegalovirus receive relatively little attention and resource allocation from pharmaceutical companies compared to the aggressive funding for more high-profile viruses such as HIV, the SARS Coronavirus and the H5N1 bird flu virus.
“Today there are many viruses for which there is an ambitious effort to develop antivirals,” Dr. Gordon said. “At a conference in China, some $1.9 billion has been committed to finding ways of preventing a possible global [bird flu] pandemic.”
Meanwhile, current ophthalmic antivirals are aging; the most recent drugs in this category were developed more than a decade ago, Dr. Gordon said.
But despite the age of these drugs, some public health officials might not see a compelling need to replace them because the current drugs are still effective, Dr. Gordon said.
He said the current drugs have not allowed resistance to develop because of the mechanism of herpetic latency. Studies have shown that antiviral resistance of HSV-1 is just 0.3% in immunocompetent patients, even though the virus has been exposed to more than 2.3 million kg of combined antivirals over the course of 20 years, he said.
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Image: Stiglich JM, OSN
Image: Archer ME, OSN |
Another possible explanation for the lack of interest in developing new ophthalmic antivirals is a perceived lack of return on investment. The world’s top selling drugs are oriented toward chronic and lifestyle diseases, Dr. Gordon said, not acute conditions.
“Last year, the combined sales for Viagra, Cialis and Levitra passed $3 billion,” he said. “In one nightmarish view of the future, resistant microorganisms will be killing and blinding people, but, fear not, erectile function will be preserved.”
Most alternatives to ophthalmic antivirals have not yet been proved viable, Dr. Gordon said. While there are many vaccines being studied for HSV-1, none has been approved.
Antimicrobial peptides, which are part of the eye’s innate immunity and are effective against bacteria, viruses and fungus, have not been successfully adapted for ophthalmic use, he said.
Even drugs that work in a test tube do not always guarantee clinical success, Dr. Gordon said.
“The burden falls on the ophthalmic pharmaceutical companies who are sponsoring this meeting to ensure that we will still have topical antibiotics and antivirals to treat patients in the future,” he said.
Preop antimicrobial lid scrubber to be available
Advanced Vision Research will introduce an antimicrobial lid scrubber that patients can use before cataract or refractive surgery or intravitreal injections, company officials said.
Jeffrey Gilbard, MD, president and chief executive officer of the company, said TheraTears SteriLid will become available over the counter nationwide this spring.
Dr. Gilbard, who developed the product, said in an interview with Ocular Surgery News that patients can use the lid scrubber twice a day for 2 to 3 days before surgery for prophylaxis against endophthalmitis. He said the scrubber can kill up to 40 strains of bacteria.
Awards
Sinskey receives Corboy 2006 Memorial Award
Robert M. Sinskey, MD, was honored here as the recipient of the Philip M. Corboy, MD, 2006 Memorial Award for Distinguished Service in Ophthalmology, sponsored by Bausch & Lomb.
Dr. Sinskey, a pioneer in the development of posterior chamber IOLs, is now a vineyard owner in Napa Valley, Calif. In accepting the Corboy award, Dr. Sinskey related some of his experiences as a vineyard owner to the audience here at the meeting. A full report of this presentation is avaiable.
Brown receives Hawaiian Eye Foundation International Award
Harry S. Brown, MD, FACS, was the 2006 recipient of the Hawaiian Eye Foundation International Award for Excellence.
Dr. Brown is the president and chief executive officer of Surgical Eye Expeditions (SEE) International, as well as a founding member of that humanitarian organization.
According to the Hawaiian Eye Foundation, the award is given to a member of the ophthalmic community who has provided an “example of excellence in their profession.”
Dr. Brown said SEE International volunteer surgeons have performed 74,000 cataract procedures worldwide in the past 5 years.
“Cataracts in developing countries are a humanitarian tragedy. Without action, world blindness is projected to double by 2020,” Dr. Brown said.
Murray Beard, president and chief executive officer of EagleVision, which sponsors the International Award for Excellence, said Dr. Brown is the first U.S. resident to receive the award since its inception in 1990.