Treatment Outcomes in the Tube Versus Trabeculectomy (TVT) Study After Five Years of Follow-up

PURPOSE: To report 5-year treatment outcomes in the Tube Versus Trabeculectomy (TVT) Study. DESIGN: Multicenter randomized clinical trial. METHODS: SETTINGS: Seventeen 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: Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C ([MMC]; 0.4 mg/mL for 4 minutes). MAIN OUTCOME MEASURES: TOP, visual acuity, use of supplemental medical therapy, and failure (IOP >21 mm Hg or not reduced by 20%, IOP <= 5 mm Hg, reoperation for glaucoma, or loss of light perception vision). RESULTS: A total of 212 eyes of 212 patients were enrolled, including 107 in the tube group and 105 in the trabeculectomy group. At 5 years, TOP (mean +/- SD) was 14.4 +/- 6.9 mm Hg in the tube group and 12.6 +/- 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean SD) was 1.4 +/- 1.3 in the tube group and 1.2 +/- 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025). CONCLUSIONS: Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement. (Am J Ophthalmol 2012;153:789-803. (C) 2012 by Elsevier Inc. All rights reserved.)