title: The singapore 5-Fluorouracil trabeculectomy study: effects on intraocular pressure control and disease progression at 3 years.
abstract: OBJECTIVE
  To report 3-year results of a randomized, controlled trial comparing the use of a single application of 5-fluorouracil (5-FU) with placebo in trabeculectomy surgery.
  
  
  METHODS
  Prospective, randomized, double-blinded treatment trial.
  
  
  METHODS
  Two hundred forty-three Asian patients with primary open-angle or primary angle-closure glaucoma undergoing primary trabeculectomy.
  
  
  METHODS
  One eye of each patient was randomized to receive either intraoperative 5-FU or normal saline (placebo) during trabeculectomy.
  
  
  METHODS
  Primary outcome measure was the level of intraocular pressure (IOP). Secondary outcomes were progression of visual field loss, rates of adverse events, and interventions after surgery.
  
  
  RESULTS
  Of the 288 eligible patients, 243 were enrolled and 228 completed 3 years follow-up; 120 patients received 5-FU and 123 received placebo. Trial failure, according to predefined IOP criteria, was lower in the 5-FU group compared with the placebo group, although the difference was only significant with a failure criterion of IOP >17 mmHg (P = 0.0154). There was no significant difference in progression of optic disc and/or visual field loss over 36 months between 5-FU and placebo (relative risk [RR], 0.67; 95% confidence interval [CI], 0.34-1.31; P = 0.239). Uveitis occurred more often in the 5-FU-treated group (14/115 [12%] vs 5/120 [4%]; P = 0.032).
  
  
  CONCLUSIONS
  This is the first masked, prospective, randomized trial reporting the effect of adjunctive 5-FU in trabeculectomy surgery in an East Asian population. The trial shows that an increased success rate can be achieved for several years after a single intraoperative treatment with 5-FU. We conclude that 5-FU is relatively safe and can be routinely used in low-risk East Asian patients.
  
  
  BACKGROUND
  The authors have no proprietary or commercial interest in any materials discussed in this article.
authors.affiliation: Singapore National Eye Center, Singapore and Singapore Eye Research Institute, Singapore. ttl_wong@hotmail.com
authors.forename: Tina T
authors.initials: TT
authors.lastname: Wong
authors.forename: Peng T
authors.initials: PT
authors.lastname: Khaw
authors.forename: Tin
authors.initials: T
authors.lastname: Aung
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Foster
authors.forename: Hla Myint
authors.initials: HM
authors.lastname: Htoon
authors.forename: Francis T S
authors.initials: FT
authors.lastname: Oen
authors.forename: Gus
authors.initials: G
authors.lastname: Gazzard
authors.forename: Rahat
authors.initials: R
authors.lastname: Husain
authors.forename: Joe G
authors.initials: JG
authors.lastname: Devereux
authors.forename: Darwin
authors.initials: D
authors.lastname: Minassian
authors.forename: Say-Beng
authors.initials: SB
authors.lastname: Tan
authors.forename: Paul T K
authors.initials: PT
authors.lastname: Chew
authors.forename: Steve K L
authors.initials: SK
authors.lastname: Seah
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; 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 / Q000502:physiology*; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D009898:Optic Disk / Q000473:pathology; D011446:Prospective Studies; D012306:Risk; D012846:Singapore; D014130:Trabeculectomy; D014794:Visual Fields
chemical_list: D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil