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See also comment(s) by Paul Palmberg •
BACKGROUND: The intraoperative application of mitomycin c for primary trabeculectomy is associated with potentially sight-threatening side-effects. This study was performed to evaluate the pressure-lowering effect of postoperative application of mitomycin c for primary trabeculectomy and to evaluate the complications of this new technique. MATERIALS AND METHODS: A randomized, prospective clinical trial with 52 consecutive patients scheduled for glaucoma surgery in one large surgical center was performed. Patients underwent routine trabeculectomy. In group 1, mitomycin c (0.05 mg/ml) was applied topically to the filtering bleb for 5 min on the 3 days after surgery (postoperative application). In group 2, no mitomycin c was applied (controls). The IOP values, visual acuity, number of antiglaucomatous medications and complications were evaluated. RESULTS: Follow-up was evaluated up to 24 months for all patients. The mean intraocular pressure decreased from 31.1 to 15.4 mmHg in group 1 and from 24.8 to 15.6 mmHg in group 2 (P = 0.79; t-test). The average number of medications decreased from 2.5 and 2.4 to 0.4 and 0.6 (P = 0.53; t-test) in groups 1 and 2, respectively. No cases of hypotony maculopathy occurred. An individual decrease of more than 25% of the IOP was present in 84.6% in group 1 and in 53.8% in group 2 (P < 0.017). Survival analysis for eyes with a complete surgical success revealed a better outcome of eyes in group 1 as compared to the eyes in group 2 (P < 0.013; log-rank test). CONCLUSIONS: To our knowledge, this is the first prospective, randomized clinical trial to evaluate the efficacy of postoperative mitomycin c application in primary trabeculectomy. The application of mitomycin significantly reduced the IOP while not increasing the rate of complications.
Dr. H. Mietz, Aschaffenburg Eye Clinic, Aschaffenburg, Germany
12.8.10 Woundhealing antifibrosis (Part of: 12 Surgical treatment > 12.8 Filtering surgery)