Academy Board Approves Funding And Scientific Support Of Lasik Quality Of Life Study With FDA

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 24 Apr 2008 - 4:00 PDT

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The American Academy of Ophthalmology's Board of Trustees today approved a proposal to participate in and co-fund a prospective study on satisfaction and quality of life after LASIK surgery. The study will be conducted jointly by the Academy, the U.S. Food and Drug Administration (FDA), the National Eye Institute (NEI) and the American Society for Cataract and Refractive Surgery (ASCRS).

"Multiple studies have documented that LASIK is safe and effective with an excellent satisfaction rate and has benefited millions of patients," said David W. Parke II, MD, president of the Academy. "The aim of this joint study is to take a closer look at the underlying factors that impact quality of life."

Greater knowledge of the quality of life for post-LASIK patients provides an opportunity to understand, anticipate and eliminate potential issues related to patient satisfaction. Quality of life refers to a patient's ability to perform activities of daily living.

"No surgery is without risk, but as physicians we are dedicated to doing everything in our power to make the LASIK procedure even better for our patients," said H. Dunbar Hoskins, Jr., MD, executive vice president of the Academy. "Exploring how LASIK impacts quality of life may uncover opportunities for improvement that can benefit all patients."

The finalized study design will include input from all partners, and the study is expected to begin in 2009.

Background

The study was recommended by a Joint LASIK Study Task Force, which includes representatives from the Academy, ASCRS, FDA and NEI. It was formed in July 2007 to examine the existing literature on LASIK satisfaction and quality of life, to determine if a new study was needed and to design a study if merited. The group was formed to address general issues concerning post-market experience with LASIK.

An ASCRS representative on the task force, Kerry Solomon, M.D., conducted an extensive analysis of the existing peer-reviewed literature and found 19 studies with 2,199 patients reporting patient satisfaction rates with LASIK. A meta-analysis of these studies found a satisfaction rate of 95.4 percent worldwide. These studies notwithstanding, there were few studies in the literature that examined patient quality of life after LASIK nor the factors that may cause dissatisfaction.

"This study promises to be a concerted, clinically robust evaluation of patient quality of life after LASIK," said Steve Schallhorn, MD, chairman of the task force protocol development committee and one of the Academy's representatives. "Our objectives for this study are to determine the level of satisfaction and the changes in quality of life after LASIK and to understand factors associated with satisfaction and dissatisfaction. "

Over the past decade there have been significant improvements with LASIK technology. 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 early 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 risks and complications are generally few and may include residual refractive error, dry eye, glare/halos and double vision. Most will resolve over time or with subsequent therapy. Vision loss that cannot be corrected is extremely rare.

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.

American Academy of Ophthalmology