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Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up.

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC

Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, 900 NW 17th Street, Miami, FL 33136, USA. sgedde@med.miami.edu

PURPOSE: To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. METHODS: Setting: Seventeen clinical centers. Study Population: Two hundred twelve patients aged 18 to 85 years who had undergone previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure > or =18 mm Hg and < or =40 mm Hg on maximum tolerated medical therapy. INTERVENTIONS: A 350-mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). Main Outcome Measures: Surgical complications, reoperation for complications, visual acuity, and cataract progression. RESULTS: Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the trabeculectomy group (P = .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the trabeculectomy group during the first year of follow-up (P = .001). Surgical complications were associated with reoperation and/or loss of > or =2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the trabeculectomy group (P = .12). CONCLUSIONS: There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures.

Published 25 December 2006 in Am J Ophthalmol, 143(1): 23-31.
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