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 mm Hg and ≤40 mm Hg 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 mm Hg in the tube group and 12.7 ± 5.8 mm Hg 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.
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