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PURPOSE: To report one-year results of the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. METHODS: Setting: 17 Clinical Centers. Study Population: Patients 18 to 85 years of age who had previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure (IOP) ≥18 mmHg and ≤40 mmHg on maximum tolerated medical therapy. Interventions: 350 mm2 Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC). Main Outcome Measures: IOP, visual acuity, and reoperation for glaucoma. RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At one year, IOP (mean ± SD) was 12.4 ± 3.9 mmHg in the tube group and 12.7 ± 5.8 mmHg in the trabeculectomy group (P = .73). The number of glaucoma medications (mean ± SD) was 1.3 ± 1.3 in the tube group and 0.5 ± 0.9 in the trabeculectomy group (P < .001). The cumulative probability of failure during the first year of follow-up was 3.9% in the tube group and 13.5% in the trabeculectomy group (P = .017). CONCLUSIONS: Nonvalved tube shunt surgery was more likely to maintain IOP control and avoid persistent hypotony or reoperation for glaucoma than trabeculectomy with MMC during the first year of follow-up in the TVT Study. Both surgical procedures produced similar IOP reduction at one year, but there was less need for supplemental medical therapy following trabeculectomy with MMC.
Dr. S.J. Gedde, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, 900 NW 17th Street, Miami, FL 33136, USA. sgedde@med.miami.edu
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
12.8.1 Without tube implant (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
13.2.1 IOP (Part of: 13 Therapeutic prognosis and outcome > 13.2 Outcome)