PURPOSE: To investigate the outcome of trabeculectomy with or without adjunctive intracameral bevacizumab. MATERIALS AND METHODS: In this prospective, double-blind, randomized clinical trial, 71 patients with primary open-angle or pseudoexfoliation glaucoma were randomly assigned to receive either 1.25 mg intracameral bevacizumab (n=36) or balanced salt solution as placebo (n=35) at the end of trabeculectomy. Success was defined as at least a 30% drop in intraocular pressure (IOP) compared with baseline values and an IOP between 6 and 21 mm Hg at the last postoperative visit with (qualified) or without (complete) glaucoma medications. RESULTS: Thirty-two patients in bevacizumab group and 33 in placebo group completed a mean follow-up of 10.7±2.1 and 10.5±2.5 months, respectively (P=0.731). The mean preoperative IOP was 28.25±5.64 and 29.11±4.65 mm Hg in the bevacizumab and placebo groups, respectively (P=0.485). Last visit IOP was 14.5±3.7 mm Hg in the bevacizumab group and 18.55±3.64 mm Hg in the placebo group (P<0.001). At last visit, complete success was achieved in 26 cases (81.3%) of bevacizumab group and 16 cases (48.5%) of placebo group (P<0.006). Filtering bleb leak during the first postoperative month was seen in 11 (34%) and in 3 (9%) cases of bevacizumab and placebo groups, respectively (P=0.013). CONCLUSIONS: A single 1.25 mg dose of intracameral bevacizumab significantly improves the success of trabeculectomy; however, it increases the risk of early filtering bleb leakage.
RCT Entities:
PURPOSE: To investigate the outcome of trabeculectomy with or without adjunctive intracameral bevacizumab. MATERIALS AND METHODS: In this prospective, double-blind, randomized clinical trial, 71 patients with primary open-angle or pseudoexfoliation glaucoma were randomly assigned to receive either 1.25 mg intracameral bevacizumab (n=36) or balanced salt solution as placebo (n=35) at the end of trabeculectomy. Success was defined as at least a 30% drop in intraocular pressure (IOP) compared with baseline values and an IOP between 6 and 21 mm Hg at the last postoperative visit with (qualified) or without (complete) glaucoma medications. RESULTS: Thirty-two patients in bevacizumab group and 33 in placebo group completed a mean follow-up of 10.7±2.1 and 10.5±2.5 months, respectively (P=0.731). The mean preoperative IOP was 28.25±5.64 and 29.11±4.65 mm Hg in the bevacizumab and placebo groups, respectively (P=0.485). Last visit IOP was 14.5±3.7 mm Hg in the bevacizumab group and 18.55±3.64 mm Hg in the placebo group (P<0.001). At last visit, complete success was achieved in 26 cases (81.3%) of bevacizumab group and 16 cases (48.5%) of placebo group (P<0.006). Filtering bleb leak during the first postoperative month was seen in 11 (34%) and in 3 (9%) cases of bevacizumab and placebo groups, respectively (P=0.013). CONCLUSIONS: A single 1.25 mg dose of intracameral bevacizumab significantly improves the success of trabeculectomy; however, it increases the risk of early filtering bleb leakage.