PURPOSE: To evaluate the prognosis of patients who develop early postoperative wound leaks after trabeculectomy, to determine risk factors for these leaks, and to document adverse outcomes. DESIGN: Multicenter randomized clinical trial. METHODS: Two-hundred thirteen patients with previous cataract surgery or failed filtering surgery were randomized to either trabeculectomy (standard group) or trabeculectomy with postoperative subconjunctival 5-fluorouracil injections (5-FU group). Masked measurements of intraocular pressure were performed throughout 5 years of follow-up. Failure was defined as a reoperation to control intraocular pressure or an intraocular pressure greater than 21 mm Hg with or without medication at or after the 1-year examination. An early postoperative wound leak was defined as one that developed within 2 weeks postoperatively, determined by daily topical fluorescein testing. RESULTS: At 1 year (5 years), the success rate for the 5-FU group was 80% (54%) in eyes without a leak, and 60% (28%) in those with a leak. The 1-year (5-year) success rate in the standard group was 50% (24%) in those without a leak and 44% (15%) with a leak. (P = .018, log-rank test, adjusted for treatment). Leaks were more common in the 5-FU group, 34/105 (32%), than in the standard treatment group, 22/108 (20%), (P = .066, χ2). More eyes with one-layer conjunctiva-Tenon capsule closure developed leaks 40/115 (35%) than those with two-layer closure 16/95 (17%) (P = .006, χ2). More eyes with a trabeculectomy located inferiorly 29/76 (38%) developed leaks than those done superiorly 27/137 (20%) (P = .006, χ2). Patients with leaks were older (66 years) than those without leaks (60 years) (P = .011, t test). CONCLUSION: An early postoperative wound leak was a risk factor for trabeculectomy failure. We recommend that trabeculectomy be performed in a superior location with a two-layer closure.
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