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Ophthalmic organizations, government agencies join forces to discuss clinical trial for dissatisfied LASIK patients

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SAN FRANCISCO — The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology, in conjunction with the U.S. Food and Drug Administration and the National Eye Institute, have assembled a joint task force charged with formulating a viable study design to identify dissatisfied post-LASIK patients, define their significant symptoms and evaluate the influence of those symptoms on quality of life, according to a joint press release from ASCRS and AAO.

The collaboration marks the first time that the FDA has called for counsel from external organizations concerning the design of such a study, the release said.

"We are pleased to have this opportunity to collaborate with the FDA and NEI on designing the study," ASCRS president, joint task force chair and Ocular Surgery News Chief Medical Editor Richard L. Lindstrom, MD, said in the release. "ASCRS and the Academy will rely upon the best interests of patients, scientific validity and transparency to guide their actions through this process."

Encouraged by FDA petitions urging for an effective freeze on nonessential eye surgeries, the FDA initially approached ASCRS in fall 2006 for assistance in designing the post-LASIK quality-of-life trial. Although the FDA did not deem the majority of requests worthy of new investigation, the agency has permitted the petitioners to present testimony at a special meeting of the Ophthalmic Devices Panel scheduled for April.

During the meeting, delegates from the Ophthalmic Devices Panel will review concerns related to poor outcomes after LASIK and implantation of phakic IOLs, and consider their effects on patients' quality-of-life, according to the release.

In addition, the ASCRS has launched a meta-analysis of the global literature regarding patient-reported outcomes and quality of life after LASIK. Task force member and study director Kerry D. Solomon, MD, is scheduled to report the results at the 2008 ASCRS-ASOA Annual Symposium and Congress in Chicago.

The joint task force has not yet made a final decision regarding the necessity and design of the study.

"Ultimately, joint task force recommendations will be put to the governing boards of the ASCRS and AAO to consider. Then, it will fall to the regulatory agencies to determine what, if any, steps need to be taken," the release said.