Mar 18, 2008 8:25 pm US/Eastern
FDA Takes Second Look At Lasik Surgery
PITTSBURGH (KDKA) ―
Laser eye surgery, known as Lasik, has helped millions of people see clearly, without wearing contacts or glasses. But now US health regulators are investigating whether the surgery is actually living up to its claims.
Lasik uses lasers to carve the clear part of the eye so that you can see better. It costs anywhere from $500 to $2,500 per eye, and many vision insurance plans don't cover it because it's considered cosmetic. A decade after its debut, the Food and Drug Administration wants a second look.
The FDA is taking a closer look at Lasik, specifically whether the vision correcting procedure improves patients' lives.
For some patients, it does.
"They get off the table and say, 'Wow,' especially people who cannot see the clock in the morning across the room," Dr. Laura Pallan, an ophtalmologist with Eger Eye group, said. "Or, cannot see their alarm clock in the morning, or faces without putting their glasses or contacts on."
But not everyone has such good results.
Known complications include dry eyes, glare, double vision, swelling, infection or blindness.
These issues come up in fewer than 2 percent of patients.
"They're reading 20/20, but they'll say, 'It's not a good 20/20.' They'll complain of glare, halos, there's something that's immeasurable," Pallan said.
The laser procedure was FDA approved in the mid 1990's. It says the information since then shows no unexpected complications, or problems occurring at an unexpected rate.
"You don't know what the 10 year results are going to be if you've only been doing it a few years. We don't know what is down the road for these patients," Pallan said.
Dr. Pallan has recently stopped performing Lasik. Low cost, high volume centers make the economics of the community ophthalmologist offering the procedure challenging.
"I really like to bond with my patients, spend more time, and I think it's worth more than that," Pallan said.
Long-term issues might come up at the FDA hearings like how to adjust for Lasik when people evenutally need cataract surgery. The hearings could happen as early as next month, but it's doubtful the FDA will reverse course seeing that for the most part the procedure has been safe and effective.
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