Sana' Muhsen1, Javiera Compan2, Tze Lai3, Christoph Kranemann2, Catherine Birt2. 1. Department of Ophthalmology, School of Medicine, The University of Jordan, Amman 11942, Jordan. 2. Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto ON M4N 3M5, Canada. 3. Department of Ophthalmology, Curtin University, Western Australia, GPO Box U1987 Perth WA 6845, Australia.
Abstract
AIM: To compare the effectiveness of postoperative adjunctive use of subconjunctival bevacizumab in altering the outcome of primary trabeculectomy in terms of sustained lowering of intraocular pressure (IOP) and reduction of postoperative bleb vascularization and fibrosis. METHODS: A prospective, one center, randomized, placebo-control study. Fifty-nine patients (59 eyes) with uncontrolled IOP under maximal tolerated medical treatment (MTMT) were recruited. A primary trabeculectomy with mitomycin C (MMC) was done and the patients were randomized to either postoperative subconjunctival injection of bevacizumab (1.25 mg/0.05 mL) or balanced salt solution (BSS). Forty-seven patients (47 eyes) completed at least one year of follow up and were included in the study. The main outcome measure was the IOP, and secondary outcome measures include bleb morphology, vascularization, and fibrosis, as well as the need for glaucoma medications and 5-fluorouracil (5-FU) needling. RESULTS: At 1-year follow up, there was no significant difference between groups for IOP (P=0.65), bleb morphology (P=0.65), and the need for glaucoma medications (P=0.65) or 5-FU needling requirements (P=0.11). However, the bevacizumab group had a higher rate of success results, lower use of glaucoma medications after surgery, and optimal bleb aspect in more patients, but more 5-FU needling procedures required. CONCLUSION: A bigger sample size is needed in order to determine whether the differences found in the bevacizumab group are statistically significant. International Journal of Ophthalmology Press.
RCT Entities:
AIM: To compare the effectiveness of postoperative adjunctive use of subconjunctival bevacizumab in altering the outcome of primary trabeculectomy in terms of sustained lowering of intraocular pressure (IOP) and reduction of postoperative bleb vascularization and fibrosis. METHODS: A prospective, one center, randomized, placebo-control study. Fifty-nine patients (59 eyes) with uncontrolled IOP under maximal tolerated medical treatment (MTMT) were recruited. A primary trabeculectomy with mitomycin C (MMC) was done and the patients were randomized to either postoperative subconjunctival injection of bevacizumab (1.25 mg/0.05 mL) or balanced salt solution (BSS). Forty-seven patients (47 eyes) completed at least one year of follow up and were included in the study. The main outcome measure was the IOP, and secondary outcome measures include bleb morphology, vascularization, and fibrosis, as well as the need for glaucoma medications and 5-fluorouracil (5-FU) needling. RESULTS: At 1-year follow up, there was no significant difference between groups for IOP (P=0.65), bleb morphology (P=0.65), and the need for glaucoma medications (P=0.65) or 5-FU needling requirements (P=0.11). However, the bevacizumab group had a higher rate of success results, lower use of glaucoma medications after surgery, and optimal bleb aspect in more patients, but more 5-FU needling procedures required. CONCLUSION: A bigger sample size is needed in order to determine whether the differences found in the bevacizumab group are statistically significant. International Journal of Ophthalmology Press.
Authors: Alicia How; Jocelyn Leng Leng Chua; Amanda Charlton; Roseline Su; Marcus Lim; Rajesh S Kumar; Jonathan G Crowston; Tina T Wong Journal: Invest Ophthalmol Vis Sci Date: 2009-09-24 Impact factor: 4.799