title: Trabeculectomy with intraoperative mitomycin C versus 5-fluorouracil. Prospective randomized clinical trial.
abstract: OBJECTIVE
  To evaluate the relative efficacy and safety of 5-fluorouracil (5-FU) and mitomycin C (MMC) when used as adjuncts with primary trabeculectomy in eyes not at high risk for failure.
  
  
  METHODS
  Prospective multicenter, randomized clinical trial.
  
  
  METHODS
  One hundred thirteen patients with primary open-angle, pseudoexfoliative, pigmentary, or angle-closure glaucoma undergoing primary trabeculectomy were recruited.
  
  
  METHODS
  One eye of each patient was randomized to receive either 5-FU (50 mg/ml for 5 minutes) or MMC (0.4 mg/ml for 2 minutes).
  
  
  METHODS
  Intraocular pressure (IOP), visual acuity, complications, and interventions were documented at fixed intervals after surgery. The study also examined progression of visual field loss, long-term complications, and bleb appearance 3 years after surgery.
  
  
  RESULTS
  Of the 108 patients with complete perioperative information, 54 eyes received 5-FU and 54 received MMC. The proportion of patients reaching different predefined target IOPs after surgery was slightly higher in the MMC group than in the 5-FU group. This difference was less than 25%, which would have been necessary to achieve statistical significance with a power of 0.8 and the sample size used. Likewise, there was no statistically significant difference between the groups with regard to mean preoperative IOP, complications, or interventions. Mean postoperative follow-up was 309 and 330 days in the 5-FU and MMC groups, respectively (P = 0.593).
  
  
  CONCLUSIONS
  5-Fluorouracil and MMC were found to be equally safe and effective adjuncts to primary trabeculectomy in the short- and medium-term postoperative periods.
authors.affiliation: Stanford University School of Medicine, Stanford, California, USA. Kuldev.Singh@forsythe.stanford.edu
authors.forename: K
authors.initials: K
authors.lastname: Singh
authors.forename: K
authors.initials: K
authors.lastname: Mehta
authors.forename: N M
authors.initials: NM
authors.lastname: Shaikh
authors.forename: J C
authors.initials: JC
authors.lastname: Tsai
authors.forename: M R
authors.initials: MR
authors.lastname: Moster
authors.forename: D L
authors.initials: DL
authors.lastname: Budenz
authors.forename: D S
authors.initials: DS
authors.lastname: Greenfield
authors.forename: P P
authors.initials: PP
authors.lastname: Chen
authors.forename: J S
authors.initials: JS
authors.lastname: Cohen
authors.forename: G S
authors.initials: GS
authors.lastname: Baerveldt
authors.forename: S
authors.initials: S
authors.lastname: Shaikh
mesh_terms: D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005901:Glaucoma / Q000628:therapy*; D006801:Humans; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D007432:Intraoperative Period; D008297:Male; D016685:Mitomycin / Q000627:therapeutic use*; D011183:Postoperative Complications; D011446:Prospective Studies; D012449:Safety; D014130:Trabeculectomy / Q000379:methods*; D016896:Treatment Outcome; D014792:Visual Acuity; D014794:Visual Fields
chemical_list: D000964:Antimetabolites, Antineoplastic; D016685:Mitomycin; D005472:Fluorouracil