The agency is conducting a study which has three phases: Phase 1, launched in July 2009, involves the design and launch of a Web-based questionnaire to assess patient-reported outcomes and evaluate quality-of-life issues after the laser-assisted eye surgery. Phase 2 will examine quality of life and satisfaction among patients treated at the Navy Refractive Surgery Center, and phase 3 will be a national, multi-center clinical trial to study quality of life after Lasik among the general population.
READ MORE LASIK LEGAL NEWSThe Associated Press reported the FDA will work with National Eye Institute and the Department of Defense on the project. "This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects from the procedure," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in an agency news release.
According to the AP, more than six million people have undergone the Lasik procedure in the country, yet relatively little is known about its safety long-term.
In 2007 Lasik recalled all 6000 LADARVision lasers worldwide after patients experienced an unusually high percentage of serious complications. An excimer laser reshapes the cornea of the eye during Lasik and changes refractive error with the intended purpose of reducing the patient's need for glasses or contact lenses. In May 2006, US Lasik clinics reported patients developing central islands after surgery. Central islands are areas of the cornea that do not receive the required amount of laser energy, creating elevated spots on the cornea.