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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01EY003765-05
Application #
3551305
Study Section
Vision Research and Training Committee (VSN)
Project Start
1981-02-01
Project End
1989-01-31
Budget Start
1985-02-01
Budget End
1986-01-31
Support Year
5
Fiscal Year
1985
Total Cost
Indirect Cost
Name
University of Southern California
Department
Type
Schools of Medicine
DUNS #
041544081
City
Los Angeles
State
CA
Country
United States
Zip Code
90033
McDonnell, P J; Fish, L A; Garbus, J (1989) Persistence of diurnal fluctuation after radial keratotomy. Refract Corneal Surg 5:89-93
Villasenor, R A; Santos, V R; Cox, K C et al. (1986) Comparison of ultrasonic corneal thickness measurements before and during surgery in the prospective evaluation of Radial Keratotomy (PERK) Study. Ophthalmology 93:327-30