LASIK Quality of Life Collaboration Project

On Oct. 19, 2010, we reported on the progress of the LASIK Quality of Life Collaboration Project (LQOLCP), a government partnership among the FDA, the Department of Defense, and the National Eye Institute. This project examines patient-reported outcomes (PROs) following LASIK. A PRO is any report coming directly from the patient about a health condition and its treatment. This three-phased project is part of FDA’s ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery.

Phase I

The first phase involves the design and implementation of a web-based questionnaire to assess outcomes commonly reported by LASIK patients, but not previously adequately measured. This phase also involves interviews with patients contemplating LASIK as well as patients who have experienced poor outcomes and those who have experienced positive outcomes. Results from these interviews have guided modifications to the questionnaire.

Phase II

The second phase involves a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), where U.S. military personnel electing LASIK will complete the questionnaire before surgery and at 1, 3, and 6 months after surgery. Enrollment for PROWL-1 began September 2011 at the Naval Medical Center San Diego. PROWL-1 will be another step in the development of the questionnaire to better measure PROs in preparation for administration in a nationally representative group of LASIK patients.

Phase III

The third phase of the LQOLCP consists of two clinical studies, called PROWL-2a and PROWL-2b.

PROWL-2a is a national, multi-center clinical study examining the reliability of the questionnaire (developed in Phase I and II of the LQOLCP) in a civilian population. Study participants will take the questionnaire prior to LASIK surgery and then take a post-operative questionnaire one month after surgery and again three months after surgery. Clinical information on participants will be analyzed along with their questionnaire responses both before and after surgery.

The FDA and the National Eye Institute of the National Institutes of Health requested proposals for participation in PROWL-2a from LASIK surgery sites with the capabilities to perform clinical research. From the submitted proposals, the five sites for this study have been selected. Enrollment in this study has begun. Patients interested in participating in this study will only be enrolled if they receive care from selected providers at participating sites and have not yet had LASIK surgery. Please go to www.clinicaltrials.gov and enter "PROWL" to find a participating site near you. PROWL-2b will use the previously evaluated questionnaire in the civilian population to provide estimates of the prevalence of PROs.

Similar to PROWL-2a, PROWL-2b will be a national, multi-center clinical study of consumers planning to have LASIK surgery. The participants will follow up for at least 6 months after the surgery.

The FDA is neither accepting proposals from clinical centers nor accepting applications from patients for PROWL-2b at this time. Additional information related to PROWL-2b will be posted to this website when available.

Organization and Process

The questionnaire and study protocols are developed by a group of government experts from the collaborating agencies. In addition to specialists from the government partnership, an independent body of subject matter authorities rigorously selected from professional organizations review the protocols, including the questionnaire, and make recommendations. This independent body has expertise in study design, statistical analysis, measuring patient-reported outcomes, eye surgery and eye care. Two patient representatives, one with a good outcome and another with a poor outcome following LASIK, are also part of the study protocol review group.

Expected Benefit of the Project

The LQOLCP will help measure patient outcomes following LASIK as well as explore factors that may affect them. The findings from the studies are expected to assist doctors and patients considering LASIK to make more informed decisions about the surgery, potentially leading to better outcomes.

Please return to this site for future updates.

LASIK Quality of Life Collaboration Project clinical studies that are actively enrolling can be found at www.clinicaltrials.gov by entering "PROWL".