Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial


Kirwan, JF; Cousens, S; Venter, L; Cook, C; Stulting, A; Roux, P; Murdoch, I; (2006) Effect of beta radiation on success of glaucoma drainage surgery in South Africa: randomised controlled trial. BMJ (Clinical research ed), 333 (7575). 942-994A. ISSN 0959-8138 DOI: https://doi.org/10.1136/bmj.38971.395301.7C

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Abstract

Objective To evaluate whether beta radiation may offer a practical method of improving surgical success for glaucoma drainage surgery in South Africa. Design Double blind, randomised controlled trial. Setting Three public hospitals in South Africa. Participants 450 black Africans with primary glaucoma. Interventions Trabeculectomy with 1000 cGy beta radiation or standard trabeculectomy without beta radiation (placebo). Main outcome measures 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%). Conclusion 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.

Item Type: Article
Keywords: OPEN-ANGLE GLAUCOMA, INTRAOCULAR-PRESSURE, LONG-TERM, CLINICAL-TRIAL, VISUAL-ACUITY, TRABECULECTOMY, IRRADIATION, INTERVENTION, ADJUNCT, AGIS, Adult, Aged, Beta Rays, Cataract Extraction, Double-Blind Method, Female, Glaucoma, Open-Angle, physiopathology, radiotherapy, surgery, Humans, Intraocular Pressure, physiology, Male, Middle Aged, Survival Analysis, Trabeculectomy, methods, Treatment Failure, Visual Acuity, physiology
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Tropical Epidemiology Group
PubMed ID: 17023435
Web of Science ID: 242157900015
URI: http://researchonline.lshtm.ac.uk/id/eprint/10617

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