Washington, D.C. -- Physicians representing the AmericanAcademyof Ophthalmology (Academy) and the International Society of Refractive Surgery (ISRS) spoke today to a meeting of the FDA’s Ophthalmic Devices Panel about the long track record of safety and effectiveness for LASIK eye surgery. LASIK has benefited millions of people, they said, and research should continue to determine how to improve outcomes even further for those who elect to have the procedure.

“LASIK is safe and effective. This has been documented in studies enrolling thousands of patients conducted over the last 15 years,” said Steve Schallhorn, MD, the Academy representative and the former director of cornea service and refractive surgery at the Naval Medical Center San Diego. “Patient satisfaction after LASIK is excellent.”

The FDA called the meeting to explore the issue of satisfaction with LASIK. The speakers before the panel included physicians and both satisfied and dissatisfied patients. 

“LASIK is the most studied elective procedure. Collectively, 7,830 patients, representing 16,502 eyes, participated in FDA clinical trials between 1993 and 2005,” said Peter McDonnell, MD, the director and William Holland Wilmer professor of ophthalmology at the Wilmer Eye Institute of the Johns Hopkins School of Medicine, who spoke on behalf of ISRS. “I believe it is safe to say that no elective ophthalmic surgical procedure has been as fully studied as has this procedure. But, as with any surgical procedure, there are complications that may occur after LASIK. Fortunately these are uncommon. No matter how uncommon, however, when complications occur they can be quite distressing to both patients and surgeons.”

Academy Supports LASIK Quality of Life Study

The FDA is planning a large prospective study on satisfaction and quality of life after LASIK surgery. Quality of life refers to a patient’s ability to perform activities of daily living. The Academy has agreed to participate in and co-fund this study, which will be conducted jointly by the Academy, the FDA, the National Eye Institute (NEI) and the American Society for Cataract and Refractive Surgery (ASCRS).

“As physicians we are dedicated to doing everything in our power to make the LASIK procedure even better for all of our patients,” Dr. Schallhorn said. “The Academy believes that knowledge gained from the study will benefit both patients and physicians, providing an opportunity to understand, anticipate and eliminate issues related to patient dissatisfaction.”

Over the past decade LASIK technology has significantly improved. This study will also help evaluate the impact of today’s changing technology. 

About LASIK

LASIK stands for Laser Assisted In-Situ Keratomileusis. LASIK is used to treat nearsightedness (myopia), farsightedness (hyperopia) and the blurriness of astigmatism. The technology was approved by the FDA in the mid 1990s. An average of 700,000 people has the procedure each year. MarketScope reports that since LASIK’s inception the surgery has been performed on more than 15 million patients worldwide and 6 million patients in the U.S.

LASIK side effects and complications are generally few and may include: the need for further vision correction through surgical retreatment, glasses or contact lenses; dry eye; glare/halos; night vision problems; and double vision. Most will resolve over time or with subsequent therapy. Vision loss that cannot be corrected is extremely rare.

Anyone considering LASIK should have an in-depth discussion with his or her ophthalmologist the benefits and risks that could result from correcting vision with surgery, rather than eyeglasses or contact lenses.

More information about LASIK can be found on the Academy’s EyeSmart Web site at www.geteyesmart.org/correction/LASIK.cfm

About the American Academy of Ophthalmology
AAO is the world's largest association of eye physicians and surgeons—Eye M.D.s—with more than 27,000 members worldwide.  Eye health care is provided by the three “O’s” – opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at www.aao.org.