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PURPOSE: To compare the safety and efficacy of intraoperative 5-fluorouracil (5-FU) or Intraoperative mitomycin C (MMC) in eyes undergoing primary trabeculectomy. DESIGN: Prospective double-masked randomized clinical trial. METHODS: One hundred and fifteen eyes of 103 patients with uncontrolled intraocular pressure (IOP) despite maximally tolerated medical therapy or laser were prospectively randomized in a double-masked fashion to one of two treatment groups in a single institution setting. Subject's eyes underwent primary trabeculectomy with either topical 5-FU (50 mg/ml for five minutes) or topical MMC (0.2 mg/ml for two minutes). Primary outcome measures included the number of eyes achieving target pressures of 21, 18, 15, and 12 mmHg at six and 12 months postoperatively. Secondary outcome measures included IOP, best-corrected visual acuity, complications, and interventions. RESULTS: Of the 115 eyes, 57 received 5-FU while 58 received MMC. A target IOP of 21 mmHg at six months was achieved in 53 of 56 (95%) eyes in the 5-FU group and 54 of 57 (95%) eyes in the MMC group (p = 1.00). At 12 months, 45 of 48 (94%) eyes in the 5-FU group met a target IOP of 21 mmHg while 48 of 54 (89%) eyes in the MMC group did (p = 0.49). The most common complications in each group were persistent choroidal effusions and bleb leak. CONCLUSIONS: This study suggests that intraoperative topical 5-FU is at least as effective as intraoperative topical MMC in reducing IOP of eyes undergoing primary trabeculectomy.
D. WuDunn, MD, Department of Ophthalmology, Indiana University, Indianapolis, IN 46202, USA. dwudunn@iupui.edu
12.8.10 Woundhealing antifibrosis (Part of: 12 Surgical treatment > 12.8 Filtering surgery)