During a recent LASIK panel symposium and subsequent discussions with the U.S. Food and Drug Administration (FDA), the American Academy of Ophthalmology (Academy) and the American Society for Cataract and Refractive Surgery (ASCRS) reviewed some aspects of the anticipated work of the LASIK Quality of Life Collaboration Project. This project examines patient-reported outcomes (PROs) following LASIK and is being conducted by the FDA, National Eye Institute (NEI) and the U.S. Department of Defense (DoD).
“The resources that the FDA, NEI and DoD are bringing to this project are impressive,” said David W. Parke II, MD, Academy CEO. “LASIK has proven to be safe and effective and has high patient satisfaction rates. We expect that a LASIK quality of life study, relying on sound science and relevant clinical experiences, will be able to shed new light on the post-LASIK patient experience.”
The LASIK Quality of Life Project is now underway. In a panel discussion at the Academy’s October 2010 Joint Meeting in Chicago, Malvina Eydelman, MD, Director, Division of Ophthalmic, Neurological and ENT Devices, Office of Device Evaluation, Center for Devices and Radiological Health, FDA, and Elizabeth Hofmeister, MD, CDR, MC, U.S. Navy on behalf of the DoD, described the study’s phases, progress to date, and anticipated progress. The steps include:
- In phase one, a Web-based questionnaire was developed to evaluate patient-reported outcomes, some of which may be related to the safety of the lasers used in this procedure, that could impact quality of life after LASIK surgery;
- Phase two will involve a clinical study called Patient-Reported Outcomes with LASIK (PROWL-1), in which U.S. military personnel who elect to have LASIK will complete the questionnaire preoperatively (before surgery) and at 1, 3, and 6 months postoperatively (after surgery). Enrollment for PROWL-1 is slated to begin within the next two months; and
- The final phase of the project, the PROWL-2 study, will be a national, multicenter clinical study with a protocol based on lessons learned and outcomes from PROWL-1.
“We believe that a scientifically sound study will affirm that the vast majority of patients are happy with their outcomes and will further refine optimal patient selection and preoperative counseling,” said R. Doyle Stulting, MD, President, ASCRS.
Numerous published studies have shown that 95 percent of patients are satisfied with their LASIK outcomes. Many of those who are not initially satisfied may have experienced issues such as glare, halos and dry eye, which usually diminish with time. Sometimes a patient’s vision is unintentionally under-corrected or over-corrected, and a surgical enhancement may be recommended to achieve optimal results.
“As with any surgery, there are risks involved with LASIK, even if the risks are generally low,” added Dr. Parke. “Patients must weigh the benefits and risks carefully before deciding to undergo any surgery,” he added.
“Our duty as physicians is to help our patients understand all of the factors that go into making this decision,” said Dr. Stulting.
About the American Society of Cataract and Refractive Surgery
The American Society of Cataract and Refractive Surgery is an international 10,000 member society of eye surgeons whose mission is to advance the art and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons. It does so by providing clinical and practice management education and by working with patients, government, and the medical community to promote the delivery of quality eye care. To find a refractive or cataract surgeon in your area, visit www.ascrs.org.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons—Eye M.D.s—with more than 29,000 members worldwide. Eye health care is provided by the three “O’s” – opticians, optometrists and ophthalmologists. It is theophthalmologist, 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 atwww.aao.org
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