Fairfax, VA — ASCRS commends and supports the participation of the U.S. Department of Defense (DoD) in the clinical study of post-LASIK patient quality of life, developed by the U.S. Food and Drug Administration in conjunction with the Joint LASIK Study Task Force of which the ASCRS was a part.

LASIK has a decade's worth of peer-reviewed, worldwide clinical data – including the FDA clinical trials --highlighting its safety and effectiveness, as well as consistent documentation of the highest patient satisfaction rate of any elective procedure (more than 95 percent).  Nevertheless, ASCRS, as part of the organized ophthalmic community, remains committed to better understanding those few patients whose expectations are not met by the procedure.  The purpose of the new study is to examine LASIK’s impact and on the diverse factors that comprise patient quality of life, including everything from driving, daily routine, family life, career and sports performance, to personal appearance after LASIK.

The DoD’s expertise with LASIK technologies and clinical protocols solidly grounded in good science serve as a solid foundation upon which to expand the scientific body of knowledge regarding LASIK, which is one of the world’s most popular elective procedures.

BACKGROUND:

•        As part of its contribution to the Joint LASIK Study Task Force, the ASCRS undertook a meta-analysis of the scientific literature on LASIK published worldwide.  The data revealed that more than 95.4 percent of all LASIK patients report being satisfied with the results of their procedure.

•        ASCRS has been actively developing a new website designed to educate patients seeking to have LASIK surgery.  The website is for the consumer looking to make informed decisions about laser vision correction, presbyopia management, and cataract surgery.

•        ASCRS, through its scientific meetings, research funding, sub-specialty clinical committees, and peer-reviewed and other publications works to enhance patient welfare by advancing the art and science of ophthalmology.

•        ASCRS has lent its support to the FDA in its development of the quality of life study and stands ready to lend further support if called upon to do so.

Re: the FDA’s inspection findings at LASIK ambulatory surgical centers:  Because we don’t have any details, ASCRS cannot comment, but the FDA announcement made clear that their inspections did not identify problems with the use of the LASIK devices at the facilities inspected.  Additionally, ASCRS supports adherence to all FDA guidelines in order to ensure quality care for patients.