PURPOSE: To evaluate the long-term corneal safety of topical mitomycin C (MMC) used during photorefractive keratectomy to prevent haze formation in highly myopic eyes. METHODS:Twenty-eight patients with bilateral high myopia underwent photorefractive keratectomy. One eye was randomly assigned to intraoperative 0.02% MMC and the fellow eye to conventional treatment. Each eye was checked at baseline and at 5 years after surgery using in vivo corneal confocal microscopy. RESULTS: At baseline, the endothelial cell density was 2970 ± 295 cells per square millimeter in the MMC-treated eyes and 2839 ± 323 cells per square millimeter in the control eyes. At 5 years, it was 2803 ± 307 and 2780 ± 264 cells per square millimeter, respectively (P = 0.27). The number of corneal nerve fibers was 3.9 ± 1.6 in the MMC-treated eyes and 4.4 ± 1.3 in the control eyes. At 5 years, it was 3.0 ± 1.6 and 2.7 ± 1.3, respectively (P = 0.15). The density of corneal nerves was 9600 ± 2915 μm/mm(2) in the MMC-treated eyes and 11,352 ± 3898 μm/mm(2) in the control eyes. At 5 years, the density was higher in the MMC-treated eyes (6790 ± 2447 μm/mm(2)) than in the control eyes (6024 ± 2977 μm/mm(2)) (P = 0.003). The number of nerve beadings at baseline was 12.9 ± 1.7/100 μm in the MMC-treated eyes and 12.3 ± 2.0/100 μm in the control eyes. At 5 years, it was 9.9 ± 2.6/100 and 9.4 ± 2.9/100 μm, respectively (P = 1.00). At 5 years, corneal nerve branching and tortuosity were similar in the 2 groups (P = 0.88 and 0.54, respectively). Epithelium thickness remained statistically unchanged (P = 0.69). CONCLUSIONS: Intraoperative use of topical 0.02% MMC compared with standard treatment does not induce significant long-term corneal changes, as assessed by in vivo corneal confocal microscopy.
RCT Entities:
PURPOSE: To evaluate the long-term corneal safety of topical mitomycin C (MMC) used during photorefractive keratectomy to prevent haze formation in highly myopic eyes. METHODS: Twenty-eight patients with bilateral high myopia underwent photorefractive keratectomy. One eye was randomly assigned to intraoperative 0.02% MMC and the fellow eye to conventional treatment. Each eye was checked at baseline and at 5 years after surgery using in vivo corneal confocal microscopy. RESULTS: At baseline, the endothelial cell density was 2970 ± 295 cells per square millimeter in the MMC-treated eyes and 2839 ± 323 cells per square millimeter in the control eyes. At 5 years, it was 2803 ± 307 and 2780 ± 264 cells per square millimeter, respectively (P = 0.27). The number of corneal nerve fibers was 3.9 ± 1.6 in the MMC-treated eyes and 4.4 ± 1.3 in the control eyes. At 5 years, it was 3.0 ± 1.6 and 2.7 ± 1.3, respectively (P = 0.15). The density of corneal nerves was 9600 ± 2915 μm/mm(2) in the MMC-treated eyes and 11,352 ± 3898 μm/mm(2) in the control eyes. At 5 years, the density was higher in the MMC-treated eyes (6790 ± 2447 μm/mm(2)) than in the control eyes (6024 ± 2977 μm/mm(2)) (P = 0.003). The number of nerve beadings at baseline was 12.9 ± 1.7/100 μm in the MMC-treated eyes and 12.3 ± 2.0/100 μm in the control eyes. At 5 years, it was 9.9 ± 2.6/100 and 9.4 ± 2.9/100 μm, respectively (P = 1.00). At 5 years, corneal nerve branching and tortuosity were similar in the 2 groups (P = 0.88 and 0.54, respectively). Epithelium thickness remained statistically unchanged (P = 0.69). CONCLUSIONS: Intraoperative use of topical 0.02% MMC compared with standard treatment does not induce significant long-term corneal changes, as assessed by in vivo corneal confocal microscopy.