At the end of April, the Ophthalmic Devices Panel of the Food and Drug Administration (FDA) heard the findings of the LASIK Study Task Force, a group comprised of representatives of the FDA, the American Academy of Ophthalmology (AAO), the American Society of Cataract and Refractive Surgery (ASCRS) and the National Eye Institute (NEI).

The LASIK Study Task Force presented findings that showed a 95.4% satisfaction rate with the procedure. The panel also included several patients who experienced both positive and negative outcomes.

The Ophthalmic Devices Panel recommended that the FDA expand upon and clarify its warnings about LASIK. Particularly, the FDA is to consider adding photographs to illustrate possible complications, specify how often it results in side effects such as dry eye, and elaborate on what factors would make a patient a poor candidate for LASIK.

The Ophthalmic Devices Panel will advise the direction and method of an upcoming large-scale prospective quality-of-life study to assess the impact of LASIK on patients daily lives. This study will be run jointly by the FDA, the AAO, the NEI and ASCRS.

As physicians, we are dedicated to doing everything in our power to make the LASIK procedure better for all of our patients, says Steven Schallhorn, M.D., who represented the AAO at the panel. The knowledge gained from the study will benefit both patients and physicians.

Vol. No: 145:06Issue: 6/15/2008