We like to think of LASIK as an accomplished technology and procedural innovation, but like many advanced medical technologies, questions remain about the safety and efficacy of the procedure and the technology that supports it. In response to anecdotal evidence of adverse vision effects experienced by some patients, possibly at a higher than expected rate, the US Food and Drug Administration (FDA) convened a public advisory panel of outside experts to review the process in 2008. What the experts heard suggested that there were many significant unanswered public health questions about LASIK.
As a result, the FDA that it decided to conduct a collaborative study with the National Eye Institute and the Department of Defense to examine the potential impact of LASIK on the quality of life of patients. The Quality of Life Project would be conducted in three phases. In the first phase, the FDA is attempting to design a questionnaire that will help doctors and regulators to better assess the quality of life impacts of LASIK treatment.
In the second phase, investigators will evaluate the quality of life and satisfaction following LASIK for patients at the Navy Refractive Surgery Center. As yet, there is no announced completion date for this phase.
Phase 3 will be a national multi-center clinical trial to study the impact on quality of life following LASIK. The goal is to assess the overall impact of LASIK on the general population, including its impact on some subpopulations that may be more vulnerable to adverse effects from the procedure. This phase is expected to be completed in 2012.
Overall, LASIK is considered a relatively safe procedure, but the FDA is acting out of the “abundance of caution” that seems to be its guiding principle these days.
To learn more about this issue and whether LASIK is right for you, please talk to an eye doctor in your area about the procedure.