title: The Singapore 5-fluorouracil trial: intraocular pressure outcomes at 8 years.
abstract: OBJECTIVE
  To report the 8-year outcomes of Asian subjects who underwent trabeculectomy augmented by intraoperative 5-fluorouracil (5-FU) or placebo.
  
  
  METHODS
  Retrospective review of a randomized controlled trial.
  
  
  METHODS
  Subjects with primary open-angle or angle-closure glaucoma.
  
  
  METHODS
  Study subjects were prospectively followed up for 3 years. After the last subject recruited had completed 8 years of follow-up, the charts of all subjects were reviewed to capture data from the year 3 visit onward. Kaplan-Meier survival function with Cox regression was performed to identify risk factors associated with trabeculectomy failure at 8 years.
  
  
  METHODS
  The primary outcome was trabeculectomy failure defined as intraocular pressure (IOP) >21 or <6 mmHg on 2 consecutive occasions after the first 6 weeks after surgery, repeat glaucoma surgery, or loss of light perception. Further end points were defined at IOP levels >17 and >14 mmHg. Secondary outcomes included IOP at 8 years and number of glaucoma medications. Complete success was defined using IOP end points ≤ 21, ≤ 17, or ≤ 14 mmHg at 8 years without medications.
  
  
  RESULTS
  Of the 243 enrolled subjects, 170 (70.0%) completed 8 years follow-up, 86 in the 5-FU and 84 in the placebo group. There was no significant difference in failure rates at 8 years for the failure definitions of IOP >21 mmHg (11.6% of the 5-FU group vs. 16.7% of the placebo group; P = 1.00), IOP >17 mmHg (23.3% of the 5-FU group vs. 31% of the placebo group; P = 0.78), and IOP >14 mmHg (46.5% of the 5-FU group vs. 58.3% of the placebo group; P = 0.37). Mean IOP at 8 years was 13.7 mmHg in the 5-FU versus 14.4 mmHg in the placebo group (P = 0.24). Mean number of medications was 0.65 drops in the 5-FU versus 0.93 drops in the placebo group (P = 0.06). Complete success with IOP ≤ 21 mmHg at 8 years was achieved in 48 subjects (55.8%) in the 5-FU and 33 subjects (39.3%) in the placebo group (P = 0.09). Absence of bleb microcysts at 1 year, preoperative IOP, and number of bleb needlings performed within the first year were significantly associated with failure.
  
  
  CONCLUSIONS
  There was no significant difference in IOP between the 5-FU and the placebo group at 8 years.
  
  
  BACKGROUND
  The author(s) have no proprietary or commercial interest in any materials discussed in this article.
authors: Singapore National Eye Centre, Singapore & Singapore Eye Research Institute, Singapore.
authors: Melissa H Y
authors: MH
authors: Wong
authors: Rahat
authors: R
authors: Husain
authors: Bryan C H
authors: BC
authors: Ang
authors: Gus
authors: G
authors: Gazzard
authors: Paul J
authors: PJ
authors: Foster
authors: Hla M
authors: HM
authors: Htoon
authors: Tina T
authors: TT
authors: Wong
authors: Francis T
authors: FT
authors: Oen
authors: Peng T
authors: PT
authors: Khaw
authors: Steve K
authors: SK
authors: Seah
authors: Tin
authors: T
authors: Aung
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D000963:Antimetabolites / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D015812:Glaucoma, Angle-Closure / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D005902:Glaucoma, Open-Angle / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D012846:Singapore; D014065:Tonometry, Ocular; D014130:Trabeculectomy; D017211:Treatment Failure; D016896:Treatment Outcome; D014794:Visual Fields
chemical_list: D000959:Antihypertensive Agents; D000963:Antimetabolites; D005472:Fluorouracil