Rationale for and design of the National Eye Institute Prospective Evaluation of Radial Keratotomy (PERK) Study.
A five-year, multicenter, collaborative clinical trial of radial keratotomy for myopia is being carried out at nine clinical centers. The study, funded by the National Eye Institute, is recruiting approximately 500 patients aged 21 years or older with -2.00 to -8.00 diopters of physiologic myopia who also meet other clearly defined eligibility criteria. Surgeons use a diamond-bladed micrometer knife to make eight radial incisions in the anterior cornea. The diameter of the central clear zone is determined by the amount of myopia and the depth of the incisions by intraoperative ultrasonic pachymetry. Investigators other than the surgeon gather all pre- and post-operative data. Examinations include measurement of visual acuity with standardized charts, verification of refractions by a second observer, measurement of corneal curvature by keratometry and photokeratoscopy, quantitation of glare with a glare tester, and measurement of the size of individual endothelial cells from specular photomicrographs with a computerized digitizer. A formal psychometric questionnaire is used to evaluate the patients' subjective response. Physician monitors insure adherence to the protocol during site visits and members of the Data and Safety Monitoring Board oversee the progress of the study. Biostatisticians at the Coordinating Center insure complete data collection, process the data, and assist in the interpretation of results.
D000047:Academies and Institutes; D002986:Clinical Trials as Topic; D003315:Cornea / Q000601:surgery*; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D006801:Humans; D008722:Methods; D009216:Myopia / Q000601:surgery*; D009885:Ophthalmology; D011446:Prospective Studies; D012107:Research Design; D013673:Technology Assessment, Biomedical; D014481:United States