ASCRS to Participate In and Co-Fund Study on Post-LASIK Quality Of Life with U.S. FDA

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FDA Reaffirms Safety & Effectiveness of LASIK

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The study will give us invaluable insight on the many and diverse factors that make up quality of life. This new knowledge will ultimately be a great benefit to patients and doctors alike.

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The American Society of Cataract and Refractive Surgery (ASCRS), , today announced that it will participate in a post-LASIK quality of life study with the Joint LASIK Study Task Force, which includes the U.S. Food and Drug Administration (FDA), the National Eye Institute (NEI), ASCRS and the American Academy of Ophthalmology. ASCRS also announced that the ASCRS Foundation has committed funds to support this effort.

The FDA reaffirms that LASIK is both safe and effective. The Joint LASIK Study Task Force now will examine LASIK’S impact on the quality of patients’ daily lives. Simply defined, quality of life refers to a patient’s ability to perform the activities of daily living, everything from driving, daily routine, family life, career and sports performance, to personal appearance, after LASIK. While the FDA reports that nearly all patients are satisfied with their procedure, the study will seek to qualify LASIK’s benefits and provide greater understanding of the very few patients whose expectations are not met with the procedure, with the goal of identifying ways to enhance patient care.

"To date, there have been few studies that looked specifically at quality of life. Most have focused on patient satisfaction – which is extraordinarily high for LASIK – but satisfaction is just one component of quality of life," said Kerry Solomon, MD, ASCRS co-chair of the Joint LASIK Study Task Force and professor of ophthalmology, Medical University of South Carolina. "The study will give us invaluable insight on the many and diverse factors that make up quality of life. This new knowledge will ultimately be a great benefit to patients and doctors alike."

Possible study outcomes could include a more holistic approach to patient screening and pre-operative patient counseling, with considerations for both physical and psychodynamic factors, as well as a better understanding of the myriad factors that comprise quality of life.

"When a procedure advances as far as LASIK has, both technologically and clinically, having a greater understanding of quality of life will help both patients and doctors, and could provide the next breakthrough in the procedure’s performance," said Richard L. Lindstrom, MD, co-chair of the Joint LASIK Study Task Force and immediate past president of the ASCRS.

Why Now
Between 1998 and 2006, the FDA received a total of 140 comments relating to LASIK dissatisfaction, representing less than 1 in 10,000 U.S. LASIK patients. In 2006, the FDA re-evaluated symptoms and satisfaction data and reaffirmed that while the vast majority of LASIK patients were indeed satisfied with their outcomes, a few were not. In 2007, the Joint LASIK Study Task Force was formed to look into quality of life and the feasibility of a post-LASIK study. As part of this process, the FDA Ophthalmic Device Panel Medical Devices Advisory Committee will discuss post-market experience with both phakic intraocular lenses (phakic IOLs) and LASIK at its regularly scheduled April 24-25 meeting.

"People undergo LASIK to improve and enhance their quality of life. The LASIK procedure was designed specifically to improve patients’ quality of life, and it has with great success for millions of people. What we are looking to do is study people that are satisfied with their procedure vs. people who aren’t – even though this is a rare occasional patient. The more we can learn from that rare occasional patient, the better this procedure can be for everyone," said Dr. Solomon.

LASIK World Literature Review: Quality of Life and Patient Satisfaction
As part of this process, ASCRS assumed the task of reviewing information on satisfaction post-LASIK through a meta-analysis of the worldwide body of scientific literature on LASIK. Findings of the meta-analysis, announced last month, revealed a 95.4 percent patient satisfaction rate among LASIK patients worldwide.

"We found there is solid evidence in the world’s scientific literature to affirm an exceptionally high level of satisfaction in patients who have had LASIK surgery – 95.4% in fact," said Dr. Solomon. "Importantly, these rates have been consistent over the past 10 years."

With almost two decades of innovation resulting in improved visual outcomes and one of the highest safety profiles of any elective procedure, Laser Assisted In-Situ Keratomileusis (LASIK) is the world's most-popular elective procedure available today. According to MarketScope, an average of 700,000 patients in the U.S. have LASIK annually to treat nearsightedness (myopia), farsightedness (hyperopia), the blurriness of astigmatism, and loss of reading vision (Presbyopia). To date, more than 28.3 million LASIK procedures have been performed worldwide, MarketScope reports.

With more than a decade of clinical research, LASIK has been extensively studied. Collectively, 7,830 patients (representing 16,502 eyes) participated in clinical trials from 1993 – 2005. Advances in LASIK technology over the past decade have led to superior safety and better visual outcomes. The recent approval of modern LASIK for U.S. Air Force fighter pilots and NASA astronaut candidates is the procedure’s latest validation.

John Ciccone


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