This prospective, randomized, monitored study evaluates the operation radial keratomy for myopia, in which 16 partial thickness peripheral, radial, corneal incisions flatten the central cornea and reduce myopia. The goal of the operation is to give the patient 20/40 or better uncorrected visual acuity, 20/20 corrected visual acuity without fluctuation or uncomfortable glare. We will recruit 40 myopic patients who meet the selection criteria detailed in the manual of operations, and assign approximately 5 patients to each of 9 groups based on their keratometry readings and refractive myopia. We will randomize the right and left eyes. Preoperative examinations will be performed in accordance with the manual of operations. A standardized radial keratomy operation will then be performed. Postoperatively, the patients will be examined at regular intervals by a physician other than the surgeon to measure alterations in visual acuity, corneal shape, refraction and glare, endothelial cell counts, patient satisfaction, and other variables as described in the manual of operations. At the end of approximately 1 year, we will examine the data to estimate the safety and efficacy of this operation in correcting myopia. These results will lead to recommendations concerning surgery on the second eye and recommendations to the ophthalmic community. Since there are approximately 11 million myopic Americans whose nearsightedness could be corrected by this surgery and since the surgery has been widely publicized, the social and economic implications of this study are substantial. This carefully designed study, which is independently monitored, should give the scientific results necessary to make rational judgments about the role of this surgery in the management of myopia.
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