OBJECTIVE: To establish the efficacy and safety of simultaneous subconjunctival and subscleral application of mitomycin-C in trabeculectomy. DESIGN: A prospective, randomized study. PARTICIPANTS: Sixty-eight patients (68 eyes) with refractory glaucomas were included in the study. INTERVENTION: Eyes were randomly assigned to receive intraoperative mitomycin-C (0.3 mg/ml) applied under the conjunctival flap (group 1), scleral flap (group 2), or under both flaps (group 3). MAIN OUTCOME MEASURES: Mean intraocular pressure (IOP), postoperative medications, visual acuity, filtering bleb appearance, and complications. RESULTS: There was a significant difference in IOP at 6, 9, and 12 months after surgery among the three groups (P = 0.021, 0.026, and 0.033, respectively ANOVA). At 12 months, the mean IOP in group 3 was 9.8+/-3.7 mm Hg compared with 13.4+/-5.5 mm Hg in group 2. (P = 0.015) and 12.4+/-4.4 mm Hg in group 1 (P = 0.039). Success rate (21 mm Hg or less), number of antiglaucoma medications, and complications showed no statistical significant difference between the three groups at each postoperative visit. CONCLUSIONS:Mitomycin-C applied under the scleral flap may have an additional beneficial effect when combined with simultaneous subconjunctival exposure.
RCT Entities:
OBJECTIVE: To establish the efficacy and safety of simultaneous subconjunctival and subscleral application of mitomycin-C in trabeculectomy. DESIGN: A prospective, randomized study. PARTICIPANTS: Sixty-eight patients (68 eyes) with refractory glaucomas were included in the study. INTERVENTION: Eyes were randomly assigned to receive intraoperative mitomycin-C (0.3 mg/ml) applied under the conjunctival flap (group 1), scleral flap (group 2), or under both flaps (group 3). MAIN OUTCOME MEASURES: Mean intraocular pressure (IOP), postoperative medications, visual acuity, filtering bleb appearance, and complications. RESULTS: There was a significant difference in IOP at 6, 9, and 12 months after surgery among the three groups (P = 0.021, 0.026, and 0.033, respectively ANOVA). At 12 months, the mean IOP in group 3 was 9.8+/-3.7 mm Hg compared with 13.4+/-5.5 mm Hg in group 2. (P = 0.015) and 12.4+/-4.4 mm Hg in group 1 (P = 0.039). Success rate (21 mm Hg or less), number of antiglaucoma medications, and complications showed no statistical significant difference between the three groups at each postoperative visit. CONCLUSIONS:Mitomycin-C applied under the scleral flap may have an additional beneficial effect when combined with simultaneous subconjunctival exposure.