LASIK under investigation

On April 28, a meeting of the FDA Ophthalmic Devices Panel confirmed that a study investigating patient satisfaction and quality of life post-LASIK is to be conducted in the US by a Joint LASIK Study Task Force. According to Daniel Schultz, head of the FDA’s medical devices centre, the study, which will not evaluate the safety or efficacy of LASIK but will evaluate the impact of changing technology, is a priority for the agency and will begin no later than 2009.

The Joint LASIK Study Task Force, formed in July 2007 to assess patient experience of LASIK, comprises members from the FDA, the American Academy of Ophthalmology (AAO), the National Eye Institute (NEI) and the American Society for Cataract and Refractive Surgery (ASCRS).

Representatives of the task force evaluated existing reports of patients’ quality of life and overall satisfaction after their surgeries, and concluded that, globally, 95.4% of patients are satisfied with their results. According to Peter McDonnell, MD, medical editor of Ophthalmology Times, between 1993 and 2005, 7830 patients (16502 eyes) participated in FDA clinical trials of LASIK; approximately six million US patients (15 million worldwide) have undergone the surgery. Between 1998 and 2006, the FDA received 140 reports of side effects. During the April 28 meeting, committee chairperson Jayne S. Weiss, MD commented, “We need to start distinguishing between the side effects that disappear and the complications.” The task force believes that a greater understanding of post-surgical quality of life will enable surgeons to increase patient satisfaction after the procedure.

The number of LASIK surgeries being performed in the US is currently falling - Market Scope, an ophthalmology market research firm, predicts a 17% drop for 2008 - but according to The New York Times (April 24, 2008), this is due to the country's weak economy and is not reflective of patient concerns with the procedure. Other elective procedures, including some cosmetic surgeries, are also being affected. In the uncertain economic climate of the beginning of this century, there was a similar three-year slump in the number of LASIK procedures performed in the US.

The design of the quality of life study is currently under evaluation but it will be a large, multicentre, prospective study, assessing which factors contribute to satisfaction and dissatisfaction following surgery, and how quality of life is impacted. The goal of the study is to increase patient satisfaction to ≥99%.