Three federal agencies -- the Food and Drug Administration, the Defense Department and the National Eye Institute -- announced Thursday that they are launching a three-year effort to gauge how many, and which, patients undergoing the vision correction procedure called LASIK suffer troubling symptoms following the surgery.
At the same time, the FDA issued letters reminding 17 walk-in surgical centers performing LASIK surgery of their obligation to report poor outcomes and patients' surgery-related medical complaints to the agency. The letters were issued after the FDA conducted a spate of inspections of LASIK facilities and found many had no system for collecting and transmitting to the FDA data on patients' reports of post-surgical "adverse events." More inspections are to come, said the FDA.
It's been almost two decades since the "Laser-Assisted In Situ Keratomileusis" -- or LASIK -- procedure was first used in the United States, and somewhere between 1.1 million and 1.4 million patients a year now undergo the surgery to correct vision defects. Aggressive marketing has made LASIK a $2-billion industry -- and one which has come under criticism for overselling the surgery's benefits and underplaying its risks. In May, the FDA circulated a letter to eye care providers calling attention to "deceptive or misleading health care advertising claims" and outlining the limits of allowable claims that may be made for LASIK.
But while LASIK has many ardent admirers among the more than 12 million in the U.S. who have had it, between 2% and 5% of patients getting the surgery -- as many as 75,000 per year -- are thought to have lasting post-operative problems that range from painful dry-eye to poorer vision, halos, glare and even blindness. The FDA calls these "quality of life" problems following the laser surgery, and has acknowledged that it has recorded no more than a small fraction of such problems during the LASIK industry's period of explosive growth. (In the 10 years leading up to an early 2008 hearing on LASIK, the agency said it had received only 140 reports of post-LASIK eye problems.)
In the first phase of the FDA-led effort to measure LASIK's effects, the agency is drafting a web-based survey of patients who have undergone the procedure. In its second phase, the Defense Department will gauge how many active-duty military patients suffered post-surgical eye problems, and whether certain populations of patients fared worse. Phase 3, which will end in 2012, is to study a general patient population across the country to determine how many, and who, suffer problems from the surgery.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says the study likely will identify which patients are at higher risk of poor outcomes and "could lead to a reduction" in those whose eye problems are made worse by the procedure.
-- Melissa Healy