title: Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial.
abstract: OBJECTIVE
  To evaluate whether beta radiation may offer a practical method of improving surgical success for glaucoma drainage surgery in South Africa.
  
  
  METHODS
  Double blind, randomised controlled trial.
  
  
  METHODS
  Three public hospitals in South Africa.
  
  
  METHODS
  450 black Africans with primary glaucoma.
  
  
  METHODS
  Trabeculectomy with 1000 cGy beta radiation or standard trabeculectomy without beta radiation (placebo).
  
  
  METHODS
  Primary outcome measure was surgical failure within 12 months (intraocular pressure > 21 mm Hg while receiving no treatment for ocular hypotension). Secondary outcomes were visual acuity, surgical reintervention for cataract, and intraoperative and postoperative complications.
  
  
  RESULTS
  320 people were recruited. beta radiation was given to 164; 20 (6%) were not seen again after surgery. One year after surgery the estimated risk of surgical failure was 30% (95% confidence interval 22% to 38%) in the placebo arm compared with 5% (2% to 10%) in the radiation arm. The radiation group experienced a higher incidence of operable cataract (18 participants) than the placebo group (five participants; P = 0.01). At two years the estimated risks with placebo and beta radiation were, respectively, 2.8% (0.9% to 8.3%) and 16.7% (10.0% to 27.3%).
  
  
  CONCLUSIONS
  beta radiation substantially reduced the risk of surgical failure after glaucoma surgery. Some evidence was, however, found of an increased risk for cataract surgery (a known complication of trabeculectomy) in the beta radiation arm during the two years after surgery.
  
  
  BACKGROUND
  ISRCTN62430622 [controlled-trials.com].
authors.affiliation: Department of Epidemiology and International Eye Health, Institute of Ophthalmology, University College London, London EC1V 9EL.
authors.forename: James F
authors.initials: JF
authors.lastname: Kirwan
authors.forename: Simon
authors.initials: S
authors.lastname: Cousens
authors.forename: Lynette
authors.initials: L
authors.lastname: Venter
authors.forename: Colin
authors.initials: C
authors.lastname: Cook
authors.forename: Andries
authors.initials: A
authors.lastname: Stulting
authors.forename: Paul
authors.initials: P
authors.lastname: Roux
authors.forename: Ian
authors.initials: I
authors.lastname: Murdoch
mesh_terms: D000328:Adult; D000368:Aged; D001610:Beta Particles; D002387:Cataract Extraction; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000503:physiopathology / Q000532:radiotherapy / Q000601:surgery*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D014130:Trabeculectomy / Q000379:methods*; D017211:Treatment Failure; D014792:Visual Acuity / Q000502:physiology