Meta-analysis of World’s Literature on post-LASIK Quality of Life and Symptoms Underway

Arlington, VA and San Francisco, CA--The American Society of Cataract and Refractive Surgery (ASCRS) and the American Academy of Ophthalmology (Academy) have joined with the U.S. Food and Drug Administration (FDA) and the National Eye Institute (NEI) to form a first-of-its-kind joint task force to discuss the design of a study to identify dissatisfied post-LASIK patients, define their significant symptoms and examine the impact of those symptoms on quality of life. The task force marks the first time that the FDA has requested guidance from outside organizations regarding the design of such a study. The task force’s goal is to hammer out issues involving the feasibility and design of a study.

“We are pleased to have this opportunity to collaborate with the FDA and NEI on designing the study,” said Richard L. Lindstrom, MD, ASCRS president and Joint Task Force Chair. “ASCRS and the Academy will rely upon the best interests of patients, scientific validity, and transparency to guide their actions through this process.”

The FDA approached ASCRS in the fall of 2006 for guidance in designing a post-LASIK quality-of-life study. The call for this study was spurred by a few FDA petitioners who urged a moratorium on eye surgeries that were not medically necessitated. Although the FDA did not see the majority of requests as meriting new investigation, the agency consented to allow the petitioners to present testimony at a special meeting of the Ophthalmic Device Panel (ODP).  The FDA has set April 24-25, 2008 for the ODP session. At this meeting panel members of the ODP will review issues related to poor outcomes from LASIK and phakic IOL devices and consider how this affects patients’ 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., executive vice president of the Academy. “Still, a small number of patients experience complications from surgery, and patients should be well informed before they make a decision about LASIK.”

The ASCRS also launched a meta-analysis on patient reported outcomes and quality of life after LASIK. Task Force member Kerry Solomon, M.D., is directing the study, which will cull through the world’s reported literature on quality of life after LASIK with various outcomes.  He is slated to report his findings at the 2008 ASCRS ASOA Annual Symposium and Congress, to be held in Chicago. The Joint Task force will also review the findings.

No final decisions by the Joint Task Force regarding the need for a study or its design have as yet been made. The task force continues to explore the development of a comprehensive patient- reported quality of life and symptoms survey instrument., ASCRS will also share any relevant information on dissatisfied patients gleaned from the World Literature Review with all task force members.

“A validated quality of life and symptoms, web-based study instrument will enhance the quality and comparability of many future studies worldwide, which clearly can be of value to patient and surgeon education, thus enhancing quality of care for decades to come,” Dr. Lindstrom said.

Ultimately, Joint Task Force recommendations will be put to the governing boards of the ASCRS and AAO to consider.  Then, it will fall to the regulatory agencies to determine what, if any, steps need to be taken.