In an October 15 press release, The FDA announced its plans to implement a 3 pronged initiative to evaluate “quality of life” issues associated with LASIK. This study will be implemented in collaboration with the National Institute of Health and the US Department of Defense. The goal of this initiative is to “determine the percentage of patients with significant quality of life
problems after LASIK surgery and identify predictors of these problems.”
The 3 phases of the initiative will be:
- Design and implement a Web‑based questionnaire to assess
patient-reported outcomes and evaluate quality of life issues
post-LASIK, some of which may relate to the safety of the lasers used
in the LASIK procedure.
- Evaluate the quality of life and satisfaction following LASIK as
reported by patients in a select, active duty population treated at the
Navy Refractive Surgery Center.
- A national, multi-center clinical trial and will study the impact of
the procedure on quality of life following LASIK in the general
population. Patient enrollment in Phases 2 and 3 have yet to begin but
plans are under.
According to the release: “The results of the project will help identify factors that can affect
quality of life following LASIK and potentially reduce the risk of
adverse effects that can impact the surgical outcome. If any of these
factors are related to the safety or effectiveness of the lasers used
in LASIK surgery, the FDA will evaluate whether any action is
necessary. The project is part of the FDA’s ongoing effort to better
monitor and improve the safety and effectiveness of the lasers used in
I think that this FDA initiative is a wonderful idea. An organized study such as this can only improve our understanding and outcomes for this incredible procedure. Once the online survey is made available, OCLI intends to forward the link to all our past LASIK patients so that they may participate in it. We will also implement a “modified” online survey of our own to compare national results with those of OCLI.