Joint task force to focus on patient dissatisfaction with LASIK

San Francisco and Fairfax, VA-The American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS) have joined with the FDA and the National Eye Institute to form a joint task force to discuss the design of a study to identify dissatisfied post-LASIK patients, define their significant symptoms, and examine the effects of those symptoms on quality of life. This effort marks the first time that the FDA has requested guidance from outside organizations regarding the design of such a study.

Ultimately, joint task force recommendations will be presented to the governing boards of the ASCRS and AAO. Then, it will fall to the regulatory agencies to determine what, if any, steps should be taken.
 
“ASCRS and the [AAO] will rely upon the best interests of patients, scientific validity, and transparency to guide their actions through this process,” said Richard L. Lindstrom, MD, ASCRS president and chairman of the joint task force.

The FDA approached ASCRS in fall 2006 for guidance in designing a post-LASIK quality-of-life study. The call for this study was spurred by FDA petitioners who urged a moratorium on eye surgeries that were not medically necessary. The agency is allowing the petitioners to testify at a special meeting of the Ophthalmic Device Panel (ODP) April 24 and 25, during which time ODP panel members will review issues related to poor outcomes from LASIK and phakic IOL devices and consider how they affect patient quality of life.

“LASIK is a safe and effective surgery for most patients, with high levels of satisfaction among those who choose it,” said H. Dunbar Hoskins Jr., MD, executive vice president of the AAO. “Still, a small number of patients experience complications from surgery, and patients should be well informed before they make a decision about LASIK.”

ASCRS also launched a meta-analysis of patient-reported outcomes and quality of life after LASIK. Task force member Kerry Solomon, MD, who directed the literature review, is slated to report the findings at the upcoming ASCRS annual meeting in Chicago. The joint task force also will review the findings.

The meta-analysis examined 2,915 peer-reviewed articles published over the past 10 years in clinical journals from North America, South America, Europe, Asia, Africa, and Australia. The research employed the Ovid and PubMed databases using the term LASIK and similar search terms. The last search was performed Jan. 8.

Among its findings:

• 95.4% of LASIK patients worldwide report satisfaction with the outcome of their procedure.

• Approximately the same percentage would recommend LASIK to a friend or would elect to undergo the procedure again.

• More than 95.2% of LASIK patients in the United States are satisfied with the outcome of their procedures.

• Outside the United States, studies from France, India, Iran, Ireland, the Netherlands, Scotland, South Africa, Spain, Turkey, United Arab Emirates, and the United Kingdom report very similar patient satisfaction rates of about 95.6%.

• The satisfaction rates in individual studies ranged from 87.2% to 100%.