title: Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up.
abstract: OBJECTIVE
  To describe postoperative complications encountered in the Tube Versus Trabeculectomy (TVT) Study during 5 years of follow-up.
  
  
  METHODS
  Multicenter randomized clinical trial.
  
  
  METHODS
  
  
  
  METHODS
  Seventeen 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) ≥18 mm Hg and ≤40 mm Hg on maximum tolerated medical therapy.
  
  
  METHODS
  Tube shunt (350-mm(2) Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC 0.4 mg/mL for 4 minutes).
  
  
  METHODS
  Surgical complications, reoperations for complications, visual acuity, and cataract progression.
  
  
  RESULTS
  Early postoperative complications occurred in 22 patients (21%) in the tube group and 39 patients (37%) in the trabeculectomy group (P = .012). Late postoperative complications developed in 36 patients (34%) in the tube group and 38 patients (36%) in the trabeculectomy group during 5 years of follow-up (P = .81). The rate of reoperation for complications was 22% in the tube group and 18% in the trabeculectomy group (P = .29). Cataract extraction was performed in 13 phakic eyes (54%) in the tube group and 9 phakic eyes (43%) in the trabeculectomy group (P = .43).
  
  
  CONCLUSIONS
  A large number of surgical complications were observed in the TVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than tube shunt surgery. The rates of late postoperative complications, reoperation for complications, and cataract extraction were similar with both surgical procedures after 5 years of follow-up.
authors.affiliation: Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Florida, USA. sgedde@med.miami.edu
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Gedde
authors.forename: Leon W
authors.initials: LW
authors.lastname: Herndon
authors.forename: James D
authors.initials: JD
authors.lastname: Brandt
authors.forename: Donald L
authors.initials: DL
authors.lastname: Budenz
authors.forename: William J
authors.initials: WJ
authors.lastname: Feuer
authors.forename: Joyce C
authors.initials: JC
authors.lastname: Schiffman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000477:Alkylating Agents / Q000008:administration & dosage; D003131:Combined Modality Therapy; 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; D011183:Postoperative Complications; D012086:Reoperation; D014130:Trabeculectomy; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000477:Alkylating Agents; D016685:Mitomycin