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 keratotomy 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, patients 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 #
5U01EY003755-07
Application #
3551286
Study Section
Vision Research and Training Committee (VSN)
Project Start
1981-02-01
Project End
1989-01-31
Budget Start
1987-02-01
Budget End
1988-01-31
Support Year
7
Fiscal Year
1987
Total Cost
Indirect Cost
Name
Louisiana State University Hsc New Orleans
Department
Type
Schools of Medicine
DUNS #
782627814
City
New Orleans
State
LA
Country
United States
Zip Code
70112
Waring 3rd, G O; Lynn, M J; Strahlman, E R et al. (1991) Stability of refraction during four years after radial keratotomy in the prospective evaluation of radial keratotomy study. Am J Ophthalmol 111:133-44
Waring 3rd, G O; Lynn, M J; Nizam, A et al. (1991) Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study five years after surgery. The Perk Study Group. Ophthalmology 98:1164-76
Waring 3rd, G O; Lynn, M J; Fielding, B et al. (1990) Results of the Prospective Evaluation of Radial Keratotomy (PERK) Study 4 years after surgery for myopia. Perk Study Group. JAMA 263:1083-91
Lynn, M J; Waring 3rd, G O; Nizam, A et al. (1989) Symmetry of refractive and visual acuity outcome in the Prospective Evaluation of Radial Keratotomy (PERK) study. Refract Corneal Surg 5:75-81
Santos, V R; Waring 3rd, G O; Lynn, M J et al. (1988) Morning-to-evening change in refraction, corneal curvature, and visual acuity 2 to 4 years after radial keratotomy in the PERK Study. Ophthalmology 95:1487-93
Cowden, J W; Lynn, M J; Waring 3rd, G O (1987) Repeated radial keratotomy in the prospective evaluation of radial keratotomy study. Am J Ophthalmol 103:423-31
Santos, V R; Waring 3rd, G O; Lynn, M J et al. (1987) Relationship between refractive error and visual acuity in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol 105:86-92
Waring 3rd, G O; Lynn, M J; Culbertson, W et al. (1987) Three-year results of the Prospective Evaluation of Radial Keratotomy (PERK) Study. Ophthalmology 94:1339-54
Busin, M; Suarez, H; Bieber, S et al. (1986) Overcorrected visual acuity improved by antiglaucoma medication after radial keratotomy. Am J Ophthalmol 101:374-5
Schanzlin, D J; Santos, V R; Waring 3rd, G O et al. (1986) Diurnal change in refraction, corneal curvature, visual acuity, and intraocular pressure after radial keratotomy in the PERK Study. Ophthalmology 93:167-75

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