Malik Y Kahook1. 1. Department of Ophthalmology, University of Colorado Denver School of Medicine, Rocky Mountain Lions Eye Institute, 1675 Aurora Court, Aurora, CO 80045, USA. malik.kahook@gmail.com
Abstract
PURPOSE: To investigate outcomes after trabeculectomy using intraoperative intravitreal ranibizumab and topical mitomycin C (MMC) vs MMC alone. DESIGN: Prospective randomized single-site pilot study. METHODS:Patients diagnosed with primary open-angle glaucoma were randomized 1:1 to either combination intravitreal ranibizumab 0.5 mg and topically applied MMC (0.4 mg/mL for 2 min) or MMC (0.4 mg/mL for 2 min) therapy alone at time of trabeculectomy surgery. The primary endpoint measured was bleb morphology and vascularity using the Moorfields Bleb Grading System. Unqualified success was defined as postoperative intraocular pressure (IOP) of >5 and <22 mm Hg and a 30% decrease from baseline without use of postoperative hypotensive drops. Qualified success was defined as postoperative IOP of >5 and <22 mm Hg and a 30% decrease from baseline with use of postoperative hypotensive drops. RESULTS: Ten patients were randomized to either standard trabeculectomy with MMC (Group A) or trabeculectomy with intravitreal ranibizumab and MMC (Group B). All patients completed the study and were classified as unqualified successes. There were statistically significant differences in peripheral bleb area (P = .02), peripheral bleb vascularity (P = .02), and non-bleb-related peripheral conjunctiva vascularity (P = .0003), with Group B exhibiting more diffuse blebs with a lower degree of vascularity. CONCLUSIONS: Combination intravitreal ranibizumab and topical MMC at time of trabeculectomy resulted in more diffuse blebs with less vascularity when compared to use of topical MMC alone. Further studies are planned to better understand the utility of anti-vascular endothelial growth factor agents as modulators of wound healing post trabeculectomy. Copyright (c) 2010 Elsevier Inc. All rights reserved.
RCT Entities:
PURPOSE: To investigate outcomes after trabeculectomy using intraoperative intravitreal ranibizumab and topical mitomycin C (MMC) vs MMC alone. DESIGN: Prospective randomized single-site pilot study. METHODS:Patients diagnosed with primary open-angle glaucoma were randomized 1:1 to either combination intravitreal ranibizumab 0.5 mg and topically applied MMC (0.4 mg/mL for 2 min) or MMC (0.4 mg/mL for 2 min) therapy alone at time of trabeculectomy surgery. The primary endpoint measured was bleb morphology and vascularity using the Moorfields Bleb Grading System. Unqualified success was defined as postoperative intraocular pressure (IOP) of >5 and <22 mm Hg and a 30% decrease from baseline without use of postoperative hypotensive drops. Qualified success was defined as postoperative IOP of >5 and <22 mm Hg and a 30% decrease from baseline with use of postoperative hypotensive drops. RESULTS: Ten patients were randomized to either standard trabeculectomy with MMC (Group A) or trabeculectomy with intravitreal ranibizumab and MMC (Group B). All patients completed the study and were classified as unqualified successes. There were statistically significant differences in peripheral bleb area (P = .02), peripheral bleb vascularity (P = .02), and non-bleb-related peripheral conjunctiva vascularity (P = .0003), with Group B exhibiting more diffuse blebs with a lower degree of vascularity. CONCLUSIONS: Combination intravitreal ranibizumab and topical MMC at time of trabeculectomy resulted in more diffuse blebs with less vascularity when compared to use of topical MMC alone. Further studies are planned to better understand the utility of anti-vascular endothelial growth factor agents as modulators of wound healing post trabeculectomy. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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