PURPOSE: To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C (MMC) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs. METHODS:Patients undergoing bleb needle revision procedures were enrolled in this study. All patients received a subconjunctival injection of 0.1 mL MMC (0.4 mg/mL) mixed with 0.1 mL preservative-free lidocaine (1%) at the beginning of the procedure. The patients were randomized into 2 cohorts assigned to receive either 1.0 mg (0.04 mL of 25 mg/mL) subconjunctival bevacizumab (treatment group) or 0.04 mL of balanced salt solution (control group) injected in an identical manner posterior to the bleb after the bleb needling. Success was defined as ≥20% reduction in intraocular pressure (IOP) without any IOP-lowering medications. Qualified success was defined as ≥20% reduction of IOP with IOP-lowering medications. Failure was defined as IOP>21 mm Hg, IOP reduction <20%, or need for additional surgery. Bleb morphology was classified using the Indiana Bleb Appearance Grading Scale. RESULTS: Six months postoperatively, in treatment group (n=29), 57% of patients achieved complete success, and 43% failed. In control group (n=29), 41% of patients achieved complete success, 7% achieved qualified success, and 52% failed. The difference in success rates between the 2 groups was not statistically significant (P=0.35). At 6 months, the mean IOP was 11.52 in treatment group and 12.83 in control group (P=0.45); patients in treatment group were on a mean of 0.16 medications as compared with 0.58 medications in control group (P=0.058). For bleb morphology of treatment group compared with control group, the blebs had less vascularity (0.76 vs. 1.20, respectively, on a scale of 0 to 4, P<0.05) and greater extent (2.68 vs. 2.36, on a scale of 0 to 3, P=0.022) in treatment group. CONCLUSIONS: There was no significant difference between the success rates and IOPs at postoperative month 6 between treatment and control groups. Postoperative blebs in the treatment group were less vascular and had greater extent.
RCT Entities:
PURPOSE: To report the 6-month comparative outcomes and bleb morphology for needle revision with bevacizumab and mitomycin C (MMC) versus MMC alone of failed trabeculectomy and ExPRESS shunt blebs. METHODS:Patients undergoing bleb needle revision procedures were enrolled in this study. All patients received a subconjunctival injection of 0.1 mL MMC (0.4 mg/mL) mixed with 0.1 mL preservative-free lidocaine (1%) at the beginning of the procedure. The patients were randomized into 2 cohorts assigned to receive either 1.0 mg (0.04 mL of 25 mg/mL) subconjunctival bevacizumab (treatment group) or 0.04 mL of balanced salt solution (control group) injected in an identical manner posterior to the bleb after the bleb needling. Success was defined as ≥20% reduction in intraocular pressure (IOP) without any IOP-lowering medications. Qualified success was defined as ≥20% reduction of IOP with IOP-lowering medications. Failure was defined as IOP>21 mm Hg, IOP reduction <20%, or need for additional surgery. Bleb morphology was classified using the Indiana Bleb Appearance Grading Scale. RESULTS: Six months postoperatively, in treatment group (n=29), 57% of patients achieved complete success, and 43% failed. In control group (n=29), 41% of patients achieved complete success, 7% achieved qualified success, and 52% failed. The difference in success rates between the 2 groups was not statistically significant (P=0.35). At 6 months, the mean IOP was 11.52 in treatment group and 12.83 in control group (P=0.45); patients in treatment group were on a mean of 0.16 medications as compared with 0.58 medications in control group (P=0.058). For bleb morphology of treatment group compared with control group, the blebs had less vascularity (0.76 vs. 1.20, respectively, on a scale of 0 to 4, P<0.05) and greater extent (2.68 vs. 2.36, on a scale of 0 to 3, P=0.022) in treatment group. CONCLUSIONS: There was no significant difference between the success rates and IOPs at postoperative month 6 between treatment and control groups. Postoperative blebs in the treatment group were less vascular and had greater extent.