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FDA Examines 'Quality of Life' for LASIK Patients
Date:4/25/2008

Panel convenes to review popular eye surgery, but complaints show it may not be for everyone

FRIDAY, April 25 (HealthDay News) -- Golf great Tiger Woods lauds vision-correcting LASIK surgery as "life changing." NASA now allows astronauts to undergo the procedure, and the U.S. military says it has been performed on 112,500 military personnel, including pilots.

But are some of the risks and complications of this elective surgery being lost in this laudatory celebration?

The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened Friday to discuss post-LASIK quality-of-life issues.

"This is ground-breaking. It's the first time anything like this has happened around refractory, or LASIK, eye surgery," said Dr. Christopher Starr, co-director of Cornea, Cataract and Refractive Surgery at New York-Presbyterian Hospital/Weill Cornell Medical College in New York City. "I think it's a good thing, because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes."

According to the LASIK Study Task Force, formed in 2007, studies indicate a 95.4 percent satisfaction rate among patients worldwide. The Task Force consists of the FDA, the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the U.S. National Eye Institute.

But of the 12.4 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA. Now the FDA is following up on those complaints.

"The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.

LASIK (laser-assisted in situ keratomileusis) surgery involves cutting a small flap in the eye's cornea using a laser. With the flap held out of the way, the surgeon can then reshape the corneal tissue with another laser. The procedure can be used for nearsightedness (as in Tiger Woods' case), farsightedness and, in some cases, astigmatism.

But, the much-touted procedure is not for everyone. Those who should rule it out include individuals who have a misshapen cornea or excessively thin cornea, who have early cataract formation or big pupils, who have dry eyes, or underlying conditions such as lupus or rheumatoid arthritis, said Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City.

Negative results can include glare and halos around lights at night. Some patients have actually had to have corneal transplants when LASIK went wrong, Starr said.

Surgeons may also rule out patients with unrealistic expectations. "I had a patient who said, 'I want to be able to see a license plate on a dark country road from a mile away,' so I didn't do it," said Cykiert, who estimated that he declines about 20 percent of patients who come to him.

Cykiert recommends that the surgeon who is going to perform the LASIK surgery also be the one to pre-screen candidates. "One of the things [the FDA] is probably going to find is that some of the people who have complaints that are valid may possibly have not been evaluated pre-operatively as thoroughly as they could have been," he said.

"It's an elective surgery, you're operating on very healthy people, healthy eyes, you don't want to take any chances," said Starr, who turns away 50 percent to 60 percent of prospective patients who come to him.

Starr himself has declined to have the procedure, because he considers himself "borderline." (Refractive surgeons in general, however, are four times more likely than the general population to undergo LASIK, according to a survey from the American Society of Cataract and Refractive Surgery.)

But while screening is good, it can always be better.

"How can we identify that subset of patients whose lives are irreversibly changed from a relatively 'safe' procedure," said Saffra.

To that end, the new task force is undertaking a study to identify additional factors to help screen candidates for LASIK.

"This is a science in evolution, and it is unacceptable to any eye physician to do harm to a patient, to have people whose lives are changed negatively forever, when it should have been a slam dunk," Saffra said.

More information

The FDA has more on LASIK.



SOURCES: Christopher E. Starr, M.D., co-director Corneal Cataract and Refractory Surgery, New York-Presbyterian Hospital/Weill Cornell Medical College, New York City; Robert Cykiert, M.D., associate professor of ophthalmology, New York University Langone Medical Center, New York City; Norman Saffra, M.D., director of ophthalmology, Maimonides Medical Center, New York City


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