Efficacy and Safety of Ologen Implant Versus Mitomycin C in Primary Trabeculectomy: A Meta-analysis of Randomized Clinical Trials.

PURPOSE: To assess the efficacy and safety of trabeculectomy with Ologen implant versus trabeculectomy with mitomycin C (MMC) for treatment of glaucoma.

PATIENTS AND METHODS: Medline, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and Google Scholar were searched for relevant randomized controlled trials. The outcome measures of efficacy were intraocular pressure and glaucoma medications reductions, and success rate. Safety estimates were measured by relative ratio for complications.

RESULTS: A total of 6 studies including 224 participants were included in this meta-analysis. Ologen implant was associated with a numerically lower but nonsignificant percentage reduction in IOP compared with MMC. The pooled absolute IOP decreases from baseline (95% confidence interval) were: 13.28 mm Hg (11.33-15.23 mm Hg) versus 15.8 mm Hg (13.21-18.38 mm Hg) at 1 month; 12.95 mm Hg (11.45-14.44 mm Hg) versus 13.87 mm Hg (11.77-15.97 mm Hg) at 3 months; 11.44 mm Hg (8.77-14.11 mm Hg) versus 13.34 mm Hg (11.48-15.20 mm Hg) at 6 months; 10.05 mm Hg (7.14-12.96 mm Hg) versus 11.59 mm Hg (10.27-12.91 mm Hg) at 12 months; and 12.17 mm Hg (8.88-15.47 mm Hg) versus 10.64 mm Hg (8.15-13.12 mm Hg) at 24 months for Ologen implant versus MMC, respectively. There was no significant difference in the reduction in glaucoma medications, success rate, and incidence of complications.

CONCLUSIONS: Trabeculectomy with an Ologen implant is comparable to the use of MMC with a similar long-term success rate. However, it does not seem to offer significant advantages of avoiding the potential complications related to MMC.