Abstract

PURPOSE: To evaluate the safety and efficacy of 5 seconds of mitomycin-C (MMC) application during photorefractive keratectomy (PRK) for low myopia. SETTING: Basir Eye Clinic, Tehran, Iran. DESIGN: Prospective randomized sham-controlled double-masked clinical trial. METHODS: Patients with low myopia and an ablation depth of less than 65 mu m were recruited. One eye of each patient was included in the study and was randomly assigned to receive intraoperative topical MMC 0.02 for 5 seconds or a balanced salt solution in the same manner (control group). Corneal haze development during the 6 months after the PRK was the main outcome measure. RESULTS: Of the 184 eligible patients (MMC = 93; control = 91), 152 (78 and 74, respectively) completed the follow-up. The postoperative haze grade was significantly lower in the MMC group (P=.01). The mean endothelial cell density was not significantly different between the MMC group and the control group preoperatively (2879.97 cells/mm(2) +/- 298.04 SD versus 2819.69 +/- 303.89 cells/mm(2); P=.22) or 6 months postoperatively (2878.79 +/- 283.04 cells/mm(2) versus 2878.79 +/- 283.04 cells/mm(2); P=.25). No notable ocular complication occurred throughout the study. CONCLUSION: Short-time application of MMC 0.02% was safe and effective in preventing haze formation in eyes having PRK with an ablation depth of less than 65 mu m compared with matched controls up to 6 months.