In October 2009, the Food and Drug Administration (FDA) announced the launch of the government funded LASIK Quality of Life Collaboration Project (LQOLCP) to supposedly help better understand the potential risk of severe problems that can result from LASIK. The agency partnered with the National Eye Institute (NEI) and the Department of Defense (DoD) to conduct the study, which was composed of three phases. The clinical study is known as PROWL for Patient-Reported Outcomes With LASIK.
In Phase 1, a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK was developed.
Phase 2, known as PROWL-1, evaluated quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center in San Diego.
Phase 3, known as PROWL-2 was a national, multi-center clinical trial, which studied the impact of the LASIK on quality of life following LASIK in the general population.
Results from PROWL-1 and PROWL-2 have been released. The numbers were not encouraging. Up to 4% of patients reported being dissatisfied with their LASIK outcome. If you are in those 4%, please contact the owner of http://VisionSimulations.com at RogerDavis@gmail.com.
What you need to know is this: Quantitative data look scientific, but have an enormous capacity to hide problems. The FDA should be evaluating LASIK for safety AND efficacy. That's its mandate. Unfortunately, its studies don't do this.
Safety is about with what can happen, and how bad it is when it does happen. Efficacy is about what usually happens. Studying safety thus requires examining the 4% in enormous detail. Questionnaires can't do that.
As such, it's necessary to actually look at the vision of these patients to understand what their experience is, and that requires vision simulations. If you participated in PROWL-1 or PROWL-2, it is possible to illustrate your vision using real photographs.
Quantitative and qualitative data are always viewed as complementary in solving important scientific problems. The world needs to know how you see.
Prowl-1, Prowl-2, FDA, LASIK Quality of Life Collaboration Project, Naval Medical Center San Diego, Stanford University School of Medicine, 20/20 Institute - Indianapolis, Durrie Vision, Johns Hopkins University School of Medicine, Vance Thompson Vision, patient-reported outcomes (PROs) following LASIK surgery, satisfaction.