Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up.
OBJECTIVE
To describe the intraoperative and postoperative complications encountered during the first year of follow-up in the Tube Versus Trabeculectomy (TVT) Study.


METHODS
Multicenter randomized clinical trial.


METHODS



METHODS
Seventeen clinical centers.


METHODS
Two hundred twelve patients aged 18 to 85 years who had undergone previous trabeculectomy and/or cataract extraction with intraocular lens implantation and uncontrolled glaucoma with intraocular pressure > 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).


METHODS
Surgical complications, reoperation for complications, visual acuity, and cataract progression.


RESULTS
Intraoperative complications occurred in seven patients (7%) in the tube group and 10 patients (10%) in the trabeculectomy group (P = .59). Postoperative complications developed in 36 patients (34%) in the tube group and 60 patients (57%) in the trabeculectomy group during the first year of follow-up (P = .001). Surgical complications were associated with reoperation and/or loss of > or =2 lines of Snellen visual acuity in 18 patients (17%) in the tube group and 28 patients (27%) in the trabeculectomy group (P = .12).


CONCLUSIONS
There were a large number of surgical complications during the first year of follow-up in the study, but most were self-limited. The incidence of postoperative complications was higher after trabeculectomy with MMC than nonvalved tube shunt surgery. Serious complications resulting in reoperation and/or vision loss occurred with similar frequency with both surgical procedures.
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
Herndon
Leon W
LW
Brandt
James D
JD
Budenz
Donald L
DL
Feuer
William J
WJ
Schiffman
Joyce C
JC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002387:Cataract Extraction; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000601:surgery*; D020327:Glaucoma Drainage Implants; D006801:Humans; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D012086:Reoperation; D014130:Trabeculectomy; D016896:Treatment Outcome; D014792:Visual Acuity