E Dahan1, G J Ben Simon, A Lafuma. 1. Department of Ophthalmology, University of Witwatersrand, Johannesburg, South Africa.
Abstract
PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG). DESIGN: Prospective, randomised study. PATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests. RESULTS:Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS. CONCLUSIONS:Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications.
RCT Entities:
PURPOSE: To compare intraocular pressure (IOP) over time after standard trabeculectomy vs Ex-PRESS implantation in patients with bilateral primary open-angle glaucoma (POAG). DESIGN: Prospective, randomised study. PATIENTS AND METHODS: This study included adult patients with bilateral POAG necessitating surgery. Each patient underwent trabeculectomy in one eye and Ex-PRESS implantation under a scleral flap in the other eye according to randomised contralateral allocations. Efficacy was assessed by IOP values and success rates (IOP threshold and/or need for topical glaucoma medication) during 30 months. Statistical analysis included Generalised Estimate Equation and Cox Survival models, and paired t-tests. RESULTS: Thirty eyes of 15 patients were studied for a mean of 23.6 months (SD, ± 6.9). At the last follow-up visit, mean pre-operative IOP decreased from 31.1 (± 14.2) to 16.2 (± 1.5) mm Hg after trabeculectomy, and from 28.1 (± 9.0) to 15.7 (± 1.8) mm Hg after Ex-PRESS implantation (P=0.001). The mean number of anti-glaucoma medicines prescribed at the last follow-up decreased from 3.7 pre-operatively (both groups) to 0.9 after trabeculectomy vs 0.3 after Ex-PRESS implantation (P=0.001). Complete success rates (5<IOP<18 mm Hg without medications) were higher with Ex-PRESS compared with trabeculectomy (P=0.0024). Postoperative complications were more frequent after trabeculectomy (33%) compared with Ex-PRESS (20%), with four trabeculectomy eyes (27%) needing postoperative interventions, compared with none with Ex-PRESS. CONCLUSIONS: Trabeculectomy and Ex-PRESS implantation provided similar IOP control, but the Ex-PRESS group had a lower rate of complications, fewer postoperative interventions, and needed less glaucoma medications.