Three-year follow-up of the tube versus trabeculectomy study.
OBJECTIVE
To report 3-year results of the Tube Versus Trabeculectomy (TVT) Study.


METHODS
Multicenter randomized clinical trial.


METHODS



METHODS
Seventeen clinical centers.


METHODS
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.


METHODS
A 350-mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC 0.4 mg/ml for 4 minutes).


METHODS
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.
Gedde
Steven J
SJ
Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, FL 33136, USA. sgedde@med.miami.edu
Schiffman
Joyce C
JC
Feuer
William J
WJ
Herndon
Leon W
LW
Brandt
James D
JD
Budenz
Donald L
DL
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002387:Cataract Extraction; D003657:Decision Making; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology*; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011183:Postoperative Complications; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D012086:Reoperation; D014065:Tonometry, Ocular; D014130:Trabeculectomy / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult
D000959:Antihypertensive Agents; D016685:Mitomycin