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The Assessment of Postoperative Refractive Surgery Patients in Clinical Research
Melissa D. Bailey
出版
Ohio State University
, 2004
URL
http://books.google.com.hk/books?id=_QD5jwEACAAJ&hl=&source=gbs_api
註釋
We examined existing data from Food and Drug Administration (FDA) clinical trials for approved ophthalmic lasers to determine if trends for improvement in outcomes occurred with changes in laser technology. The repeatability of autorefraction measurements, visual acuity measurements, and the National Eye Institute Refractive Error Quality of Life (NEI-RQL-42) Questionnaire was evaluated in laser in situ keratomileusis (LASIK) patients. We also compared the performance of the NEI-RQL-42 to another survey for refractive surgery patients to see if similar results were obtained when subjects completed the surveys simultaneously. Finally, we evaluated patient survey responses and opinions of eye care practitioners to provide direction for generating hypotheses for future research studies. We found that cycloplegic autorefraction measurements with the Grand Seiko autorefractor were repeatable and agreed well with subjective refraction. The NEI-RQL-42 was determined to have an acceptable level of repeatability and produced results that were similar to other studies that tested refractive surgery patients. Measurements of low-contrast visual acuity under various lighting conditions were also found to have acceptable levels of repeatability, and 5% contrast visual acuity appears to be sensitive to differences between LASIK and non-LASIK patients. When evaluating reasons why patients would recommend LASIK to others, we determined that the primary reason was to eliminate the need for glasses and/or contact lenses. Focus group sessions with eye care practitioners revealed that practitioners would like to have more information about the relationship between patient personality and psychological issues and satisfaction with the results of the procedure. The eye care practitioners defined a successful LASIK procedure as one in which the patients had good uncorrected visual acuity, refractive error within " 0.50 D of the intended correction, and no new or increase in night vision or dry eye symptoms. Future studies in corneal refractive surgery patients should be able to use the measurement techniques evaluated in these studies to answer the following two research questions: What factors are associated with the dependence on glasses and/or contact lenses five years after LASIK, and what psychological factors are associated with the patient's view of a LASIK procedure?