- The Washington Times - Saturday, April 26, 2008

ASSOCIATED PRESS

A panel of medical advisers — mostly eye doctors wearing glasses — listened to tales of woe and wonder yesterday from people who sought to get rid of their specs through Lasik surgery.

What was clear by day’s end: The vast majority of people undergoing laser eye surgery benefit and are happy, but a small fraction, perhaps fewer than 1 percent, suffer serious, life-changing side effects worsened vision, painful dry eye, glare, inability to drive at night.

Advisers to the Food and Drug Administration heard about a dozen of those stories yesterday — including a father reading his son’s suicide note — and concluded that warnings for would-be Lasik recipients should be made more clear.

Another lesson: Choose a surgeon carefully.

“This is a referendum on the performance of Lasik by some surgeons who should be doing a better job,” said Dr. Jayne Weiss of Detroit’s Kresge Eye Institute. She chaired the panel.

About 700,000 Americans a year undergo the elective laser surgery. Like golf star and famed Lasik recipient Tiger Woods, they’re hoping to throw away their glasses, just as the ads say.

But about one in four people seeking Lasik is not a good candidate, and the FDA agrees with eye surgeons’ studies that about 5 percent of Lasik recipients wind up unsatisfied. Now the agency is trying to better understand how many of those people are badly harmed, and how many just are unhappy they didn’t get as clear vision as they’d expected.

“Too many Americans have been harmed by this procedure and it’s about time this message was heard,” David Shell of Washington testified, holding up large photographs that he said depict his blurred world, with halos around objects and double vision.

“I see multiple moons,” he said angrily. “Anybody want to have Lasik now?”

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Mr. Dorrian, but he received Lasik anyway — and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

“As soon as my eyes went bad, I fell into a deeper depression than I’d ever experienced, and I couldn’t get out,” Gerard Dorrian read from his son’s suicide note.

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But, he said, “For the last two years I have suffered debilitating and unremitting eye pain. … Patients do not want to continue to exist as helpless victims with no voice.”

The sober testimonies illustrated that a decade after Lasik hit the market, there still are questions about just how often patients suffer bad outcomes from the $2,000-per-eye procedure.

Meanwhile, the FDA’s advisers recommended adding more clearly worded warnings about the risks to the brochures that every would-be patient is supposed to receive, and spell out that anyone whose nearsightedness is fixed by Lasik is guaranteed to need reading glasses in middle age, something that might not be needed if they skip Lasik.

That’s a big reason why Dr. Weiss, the ophthalmologist, won’t get Lasik even though she offers it to her patients.

“I can read without my glasses and … operate without my glasses, and I love that,” she said. “The second aspect is I would not tolerate any risk for myself. … Does that mean Lasik is good or not good? It means Lasik is good but not for everyone.”

Lasik is marketed as quick and painless: Doctors cut a flap in the cornea the eye’s clear covering aim a laser underneath it and zap it to reshape the cornea for sharper sight.

“Millions of patients have benefited” from Lasik, said Dr. Peter McDonnell of Johns Hopkins University, a spokesman for the American Academy of Ophthalmologists. “No matter how uncommon, when complications occur, they can be distressing. … We’re dedicated to doing everything in our power to make the Lasik procedure even better for all our patients.”


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