title: Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up.
abstract: OBJECTIVE
  To report 5-year treatment outcomes in 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 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
  IOP, visual acuity, use of supplemental medical therapy, 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 5 years, IOP (mean ± SD) was 14.4 ± 6.9 mm Hg in the tube group and 12.6 ± 5.9 mm Hg in the trabeculectomy group (P = .12). The number of glaucoma medications (mean ± SD) was 1.4 ± 1.3 in the tube group and 1.2 ± 1.5 in the trabeculectomy group (P = .23). The cumulative probability of failure during 5 years of follow-up was 29.8% in the tube group and 46.9% in the trabeculectomy group (P = .002; hazard ratio = 2.15; 95% confidence interval = 1.30 to 3.56). The rate of reoperation for glaucoma was 9% in the tube group and 29% in the trabeculectomy group (P = .025).
  
  
  CONCLUSIONS
  Tube shunt surgery had a higher success rate compared to trabeculectomy with MMC during 5 years of follow-up in the TVT Study. Both procedures were associated with similar IOP reduction and use of supplemental medical therapy at 5 years. Additional glaucoma surgery was needed more frequently after trabeculectomy with MMC than tube shunt placement.
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: Joyce C
authors.initials: JC
authors.lastname: Schiffman
authors.forename: William J
authors.initials: WJ
authors.lastname: Feuer
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
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000477:Alkylating Agents / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000008:administration & dosage; D002387:Cataract Extraction; 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; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D012086:Reoperation; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000477:Alkylating Agents; D000959:Antihypertensive Agents; D016685:Mitomycin