ASCRS to co-fund, participate in LASIK quality-of-life study
[b][i][u][size=3][color=red]OSN SuperSite Top Story 4/8/2008[/color][/size][/u][/i][/b][font=Times New Roman][size=3][color=green]CHICAGO — The American Society of Cataract and Refractive Surgery[b][u] committed[/u][color=magenta]（许诺）[/color][/b] funds to and will participate in a study on quality of life after LASIK to be conducted jointly with the American Academy of Ophthalmology, the U.S. Food and Drug Administration and the [b][u]National Eye Institute[/u][color=magenta]（国立眼科研究所）,[/color][/b] the society announced here.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]"Today, while we reaffirm the safety and effectiveness of LASIK, we are pleased to announce that ASCRS will participate in and co-fund a study on the impact of LASIK on quality of life," said Richard L. Lindstrom, MD, Chief Medical Editor of [i]Ocular Surgery News[/i], immediate past president of ASCRS and co-chair of the ASCRS [u][b]task force[/b][/u] [color=magenta][b]（专业小组）[/b][/color]on LASIK.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]"Every one of the four sponsors has committed significant volunteer and/or employee resources. The FDA has committed dollars to this, and at this meeting, the ASCRS executive committee and the foundation board did commit to co-fund the study," he explained.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]Dr. Lindstrom said that they did not currently have a [i][u][b]specific monetary amount[color=magenta]（确切的资金数量）[/color][/b][/u][/i] as the cost of the study has not yet been determined. He was joined by Kerry D. Solomon, MD, co-chair of the task force, and Steven C. Schallhorn, MD, who is the chairman of the protocol development committee for the proposed study.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]Dr. Schallhorn explained that the study is still under evaluation, but that the four co-sponsors have agreed on the [b][u]fundamentals[/u][color=magenta]（原理） [/color][/b]of having a large, multicenter, prospective study. The current [color=red]objectives[/color] are to [color=red][b]（[/b][/color]reconfirm the 95% satisfaction rate shown by Dr. Solomon's meta-analysis of published literature; to determine changes in the quality of life; and to further understand what contributes to satisfaction or dissatisfaction,[color=red][b]）[/b][/color] he said.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]"I think it's important that there's an appreciation that what we're talking about here is not the safety and effectiveness of LASIK. That has never been an issue," Dr. Schallhorn said. "The confines of the study are really dealing with the quality-of-life issues and especially the quality-of-life issues in those few patients who are dissatisfied."[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]Dr. Solomon and Dr. Schallhorn explained that many factors contribute to dissatisfaction with LASIK, many of which are present before the patient's procedure, such as dry eye, night vision symptoms and psychological tendencies.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]"Our goal as physicians is to put patients first and to try to continue to improve this procedure. We're always trying to make the procedure better because that's in the best interest of our patients, and the more we learn about this procedure, the more we can help those very few patients who may be dissatisfied or unhappy," Dr. Solomon said. "Our short-term and long-term goals are to improve LASIK satisfaction to 99% or higher and minimize or eliminate patient dissatisfaction."[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]Dr. Lindstrom said that the society has [color=seagreen][u][b]submitted to[/b][/u] [/color][color=magenta][b]（呈交）[/b][/color]the FDA the names of himself, Dr. Schallhorn, Dr. Solomon, David J. Tanzer, MD, and Peter J. McDonnell, MD, to speak at the upcoming meeting of the FDA Ophthalmic Devices Panel of the Medical Devices Advisory Committee on April 24 and 25.[/color][/size][/font]
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[font=Times New Roman][size=3][color=green]"I believe that the primary patient advocate, worldwide, is the physician and surgeon, and representing 10,000 ophthalmic surgeons worldwide, I believe this study is consistent with our mission," Dr. Lindstrom said.[/color][/size][/font]
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