TY - JOUR
T1 - Three-Year Follow-up of the Tube Versus Trabeculectomy Study
AU - Tube Versus Trabeculectomy Study Group
AU - Gedde, Steven J.
AU - Schiffman, Joyce C.
AU - Feuer, William J.
AU - Herndon, Leon W.
AU - Brandt, James D.
AU - Budenz, Donald L.
N1 - Funding Information:
This study was supported by Research Grants from Pfizer Inc, New York, New York; Advanced Medical Optics, Irvine, California; the National Eye Institute (Grant No. EY014801), National Institutes of Health, Bethesda, Maryland; and Research to Prevent Blindness Inc, New York, New York. The following investigators have disclosed a financial interest in the previous or current manufacturer of the Baerveldt glaucoma implant: Keith Barton: Pfizer, grant support, honoraria; Advanced Medical Optics, grant support. James Brandt: Pfizer, consultant, honoraria; Advanced Medical Optics, consultant. Donald Budenz: Pfizer, consultant, grant support, honoraria. Francisco Fantes: Pfizer, honoraria. William Feuer: Advanced Medical Optics, grant support. David Greenfield: Pfizer, consultant, grant support, honoraria. Leon Herndon: Pfizer, honoraria. Dale Heuer: Pfizer, consultant, honoraria. Paul Kaufman: Pfizer, honoraria, travel expenses. Richard Lee: Pfizer, consultant, stock. Quang Nguyen: Pfizer, consultant, honoraria. Paul Palmberg: Pfizer, consultant, honoraria. Richard Parrish II: Pfizer, consultant, honoraria. Adam Reynolds: Pfizer, speaker's bureau. Steven Sarkisian: Pfizer, honoraria. Joyce Schiffman: Advanced Medical Optics, grant support. Kuldev Singh: Pfizer, consultant, honoraria. Gregory Skuta: Pfizer, consultant. George Spaeth: Pfizer, consultant, grant support, honoraria. Rohit Varma: Pfizer, consultant, grant support, honoraria. Darrell WuDunn: Pfizer, honoraria. Involved in design and conduct of study (S.J.G., J.C.S., W.J.F., L.W.H., J.D.B., D.L.B.); collection, management, analysis, and interpretation of data (S.J.G., J.C.S., W.J.F., L.W.H., J.D.B., D.L.B.); and preparation, review, and approval of the manuscript (S.J.G., J.C.S., W.J.F., L.W.H., J.D.B., D.L.B.). The study was approved by the Institutional Review Board at each clinical center. The study adhered to the Declaration of Helsinki and the Health Insurance Portability and Accountability Act (HIPAA). This study is registered at http://www.clinicaltrials.gov ( NCT00306852 ).
PY - 2009/11
Y1 - 2009/11
N2 - 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) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 350-mm2 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 ≤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 ≥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.
AB - 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) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy. interventions: A 350-mm2 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 ≤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 ≥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.
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U2 - 10.1016/j.ajo.2009.06.018
DO - 10.1016/j.ajo.2009.06.018
M3 - Article
C2 - 19674729
AN - SCOPUS:70350471224
VL - 148
SP - 670
EP - 684
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 5
ER -