title: A comparative clinical trial of mitomycin C and cyclosporin A in trabeculectomy.
abstract: This prospective, randomized clinical trial assessed the effects of mitomycin C and cyclosporin A used as antimetabolites in trabeculectomy on the post-operative IOP and success rate. Eighty-six consecutive patients were randomly allocated to three treatment groups. There were 30 patients in the mitomycin C group, 28 in the cyclosporin A group and 28 in the control group. The follow-up periods were different for the three groups and ranged from 6 to 30 months. The treatment groups consisted of primary open-angle glaucoma, closed-angle glaucoma, various secondary glaucomas and prior failed trabeculectomy. There were no significant differences pre-operatively with respect to IOP and number of medications used (p > 0.05). Postoperative IOP was considered to be successfully reduced when it was reduced by more than 25% from baseline or when it was lower than 20 mmHg. According to these criteria, IOP was under control in 90% of the mitomycin C treated eyes, 85.7% of cyclosporin A treated eyes and 71.4% of the control eyes. Postoperatively there was a significant decrease in IOP (p < 0.01) and in the number of medications need to control IOP (p < 0.01) in the mitomycin C and cyclosporin A groups. Post-operative IOP and number of medications in the mitomycin C and cyclosporin A group were similar. Complications encountered in the three groups were similar. There were no serious complications like hypotonus maculopathy. Our study highlights the utility of mitomycin C as an adjunct in glaucoma filtering surgery and indicated that cyclosporin A may also be used as an antimetabolite.
authors.affiliation: Department of Ophthalmology, Faculty of Medicine, University of Ankara, Turkey.
authors.forename: E
authors.initials: E
authors.lastname: Turaçli
authors.forename: K
authors.initials: K
authors.lastname: Gündüz
authors.forename: G
authors.initials: G
authors.lastname: Aktan
authors.forename: C
authors.initials: C
authors.lastname: Tamer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000963:Antimetabolites / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002648:Child; D002675:Child, Preschool; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005347:Fibroblasts / Q000187:drug effects; D005500:Follow-Up Studies; D005901:Glaucoma / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D014130:Trabeculectomy; D016896:Treatment Outcome
chemical_list: D000963:Antimetabolites; D009883:Ophthalmic Solutions; D016685:Mitomycin; D016572:Cyclosporine