Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up.
OBJECTIVE
To report one-year results of the Tube Versus Trabeculectomy (TVT) Study.


METHODS
Multicenter randomized clinical trial.


METHODS



METHODS
17 Clinical Centers.


METHODS
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) > or =18 mm Hg and < or =40 mm Hg on maximum tolerated medical therapy.


METHODS
350 mm(2) Baerveldt glaucoma implant or trabeculectomy with mitomycin C (MMC).


METHODS
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.
Gedde
Steven J
SJ
Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, 900 NW 17th Street, 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; D000903:Antibiotics, Antineoplastic; D002387:Cataract Extraction; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000503:physiopathology / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D019919:Prosthesis Implantation; D019591:Pseudophakia / Q000150:complications; D012086:Reoperation; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D000903:Antibiotics, Antineoplastic; D016685:Mitomycin