Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial.
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].
Kirwan
James F
JF
Department of Epidemiology and International Eye Health, Institute of Ophthalmology, University College London, London EC1V 9EL.
Cousens
Simon
S
Venter
Lynette
L
Cook
Colin
C
Stulting
Andries
A
Roux
Paul
P
Murdoch
Ian
I
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