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FDA Panel Urges Stronger Warnings for LASIK Surgery

Colin Dorrian was a law school student from suburban Philadelphia when he was told he wasn't a good candidate for LASIK, but got the surgery anyway. His father, Gerald, detailed on Friday the six years of eye pain and blurred vision experienced by his son, before reading his child's suicide note: "I can't and won't continue facing this horror," the news service reported.

Matt Kotsovolos worked for the Duke Eye Center when he had a more sophisticated LASIK procedure in 2006, and said his doctors classified him as a success because he now has 20-20 vision -- something Kotsovolos called a deceptive industry practice, according to theAP.

"For the last two years, I have suffered debilitating and unremitting eye pain," Kotsovolos said. "Patients do not want to continue to exist as helpless victims with no voice."

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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