PURPOSE: To report 3-year results of the Tube Versus
Trabeculectomy (TVT) Study. DESIGN: Multicenter
randomized clinical trial. METHODS: setting: Seventeen clinical centers.
study population: Patients 18 to 85 years of age who had previous
trabeculectomy,
cataract extraction with
intraocular lens implantation, or both and uncontrolled
glaucoma with
intraocular pressure (IOP) > 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 0.4 mg/ml for 4 minutes). main outcome measures: IOP,
visual acuity, use of supplemental medical therapy,
surgical complications, and failure (IOP >21 mm Hg or not reduced by 20%, IOP < or =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 3 years, IOP (
mean +/-
standard deviation [SD]) was 13.0 +/- 4.9 mm Hg in the tube group and 13.3 +/- 6.8 mm Hg in the
trabeculectomy group (P = .78). The number of
glaucoma medications (
mean +/- SD) was 1.3 +/- 1.3 in the tube group and 1.0 +/- 1.5 in the
trabeculectomy group (P = .30). The
cumulative probability of failure during the first 3 years of follow-up was 15.1% in the tube group and 30.7% in the
trabeculectomy group (P = .010; hazards ratio, 2.2; 95%
confidence interval, 1.2 to 4.1). Postoperative complications developed in 42 patients (39%) in the tube group and 63 patients (60%) in the
trabeculectomy group (P = .004).
Surgical complications were associated with reoperation and/or loss of > or =2
Snellen lines in 24 patients (22%) in the tube group and 28 patients (27%) in the
trabeculectomy group (P = .58). CONCLUSIONS: Tube shunt
surgery had a higher success rate compared to
trabeculectomy with MMC during the first 3 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 3 years. While the incidence of postoperative complications was higher following
trabeculectomy with MMC relative to tube shunt
surgery, most complications were transient and self-limited.
