Background: Excimer laser photorefractive keratectomy for the correction of myopia is presently under investigation in the United States by the Food and Drug Administration (FDA). The Phase II-B FDA study is being conducted on 75 normally sighted myopic eyes utilizing three currently available excimer lasers. This report presents the 1-year results on 12 myopic eyes treated with the VISX excimer laser system at the Ellis Eye Center at Cedars-Sinai Medical Center in Los Angeles under the Phase II-B FDA protocol.
Methods: Twelve eyes of 12 patients with myopia between -1.75 and -5.00 diopters underwent 193 nm argon/fluoride excimer laser photorefractive keratectomy. The epithelium was mechanically removed, and fixation was accomplished with a suction ring which provided nitrogen flow across the corneal surface. The computer controlled corneal ablations were 5.00 mm in diameter and were accomplished with an iris diaphragm closing from large to small.
Results: The preoperative spherical equivalent myopia was -3.50 D (SD = 1.02) and the postoperative myopia was -0.25 (SD = 0.48). Eleven of the 12 patients achieved an uncorrected visual acuity of 20/30 or better and were corrected to within +/- 0.50 D of emmetropia. All corneas demonstrated a mild reticular subepithelial haze which was barely visible at 1 year. There were no vision-threatening complications and none of the eyes experienced a loss of best corrected visual acuity.
Conclusions: In this small trial, the excimer laser appears to be capable of accurately changing the refractive power of the cornea for the correction of myopia with minimal side effects. Only when larger numbers of patients undergo the procedure will we be able to determine the safety and efficacy of photorefractive keratectomy as a refractive surgical procedure.