Prognoi and rik factor for early potoperative wound leak after trabeculectomy with and without 5-Fluorouracil

PURPOE: To evaluate the prognoi of patient who develop early potoperative wound leak after trabeculectomy, to determine rik factor for thee leak, and to document advere outcome. DEIGN: Multicenter randomized clinical trial. METHOD: Two-hundred thirteen patient with previou cataract urgery or failed filtering urgery were randomized to either trabeculectomy (tandard group) or trabeculectomy with potoperative ubconjunctival 5-fluorouracil injection (5-FU group). Maked meaurement of intraocular preure were performed throughout 5 year of follow-up. Failure wa defined a a reoperation to control intraocular preure or an intraocular preure greater than 21 mm Hg with or without medication at or after the 1-year examination. An early potoperative wound leak wa defined a one that developed within 2 week potoperatively, determined by daily topical fluorecein teting. REULT: At 1 year (5 year), the ucce rate for the 5-FU group wa 80% (54%) in eye without a leak, and 60% (28%) in thoe with a leak. The 1-year (5-year) ucce rate in the tandard group wa 50% (24%) in thoe without a leak and 44% (15%) with a leak. (P = .018, log-rank tet, adjuted for treatment). Leak were more common in the 5-FU group, 34/105 (32%), than in the tandard treatment group, 22/108 (20%), (P = .066, χ2). More eye with one-layer conjunctiva-Tenon capule cloure developed leak 40/115 (35%) than thoe with two-layer cloure 16/95 (17%) (P = .006, χ2). More eye with a trabeculectomy located inferiorly 29/76 (38%) developed leak than thoe done uperiorly 27/137 (20%) (P = .006, χ2). Patient with leak were older (66 year) than thoe without leak (60 year) (P = .011, t tet). CONCLUION: An early potoperative wound leak wa a rik factor for trabeculectomy failure. We recommend that trabeculectomy be performed in a uperior location with a two-layer cloure.