FDA to Study Risks Associated with LASIK Eye Surgery

On October 15, 2009 the US Food and Drug Administration (FDA) announced that it would be studying, together with the National Eye Institute and the Department of Defense, adverse effects associated with laser eye-correcting surgery. The adverse effects to be studied include blurred vision, dry eyes, double vision, and the appearance of halos around objects at night.

Approximately six million Americans have undergone the Lasik procedure, which reshapes the cornea, a transparent, dome-shaped layer of tissue that covers the eye. Undergoing the procedure does not guarantee 20/20 vision, and the long-term safety of the surgery is not yet known. Lasik procedures can also be pricey, with typical costs ranging between $1,500 and $5,000.

One phase of the study will consist of an online questionnaire in which patients track their quality of life following their procedure. Another phase will involve a clinical trial that tracks patients who undergo the surgery. The clinical trial is expected to conclude by 2012.

The study was prompted in part by 140 reports of Lasik-related problems the FDA had received between 1998 and 2006. The agency had also received letters from regulators alleging inadequate adverse event reporting procedures at some Lasik centers. The FDA is also planning to perform more inspections of facilities where the procedures are performed.

Dr. Jeffrey Shuren, who currently leads the FDA’s medical device division, hopes “This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects”.