PURPOSE: The purpose of the study is to determine the optimum regimen of intraoperative administration of mitomycin as an adjunct to trabeculectomy. METHODS: Of 11 patients with primary open-angle glaucoma, 22 eyes that had not undergone any surgical intervention were included. In each patient, one eye was randomly allocated to a mitomycin 0.2-mg group and the fellow eye to a mitomycin 0.02-mg group. Mitomycin was applied for 5 minutes only once during trabeculectomy. The follow-up period was 6 to 17 months. RESULTS: Eleven (100%) eyes in the 0.2-mg group and 7 (63.6%) in the 0.02-mg group achieved successful control of intraocular pressure with or without topical antiglaucoma medication. Transient hypotony maculopathy (18%) and cataract progression (18%) were noted in the 0.2-mg group exclusively. The incidence of other complications was similar between the two groups. CONCLUSION: These data suggest that the most appropriate dose of mitomycin for primary surgery seems to be in between the two doses tested in the current study.
RCT Entities:
PURPOSE: The purpose of the study is to determine the optimum regimen of intraoperative administration of mitomycin as an adjunct to trabeculectomy. METHODS: Of 11 patients with primary open-angle glaucoma, 22 eyes that had not undergone any surgical intervention were included. In each patient, one eye was randomly allocated to a mitomycin 0.2-mg group and the fellow eye to a mitomycin 0.02-mg group. Mitomycin was applied for 5 minutes only once during trabeculectomy. The follow-up period was 6 to 17 months. RESULTS: Eleven (100%) eyes in the 0.2-mg group and 7 (63.6%) in the 0.02-mg group achieved successful control of intraocular pressure with or without topical antiglaucoma medication. Transient hypotony maculopathy (18%) and cataract progression (18%) were noted in the 0.2-mg group exclusively. The incidence of other complications was similar between the two groups. CONCLUSION: These data suggest that the most appropriate dose of mitomycin for primary surgery seems to be in between the two doses tested in the current study.