Trabeculectomy using mitomycin C versus an atelocollagen implant: clinical results of a randomized trial and histopathologic findings.

ABSTRACT

PURPOSE: To assess the efficacy of trabeculectomy with a biodegradable Ologen™ implant (OLO) versus mitomycin C (MMC) in patients in a prospective randomized clinical trial. METHODS: In the MMC group (15 patients), trabeculectomy was performed according to standard protocols. In the OLO group (15 patients) after standard trabeculectomy, the implant was positioned on top of the scleral flap, and no MMC was applied. RESULTS: Mean preoperative intraocular pressure (IOP) levels (OLO 28.0 ± 9.4; MMC 23.9 ± 5.0 mm Hg; p = 0.21) and medication score (OLO 3.4 ± 1.6; MMC 3.6 ± 1.5; p = 0.56) were comparable in both groups. One year after surgery, the mean IOP was 15.9 ± 4.5 mm Hg in the OLO group (p < 0.01, 43% reduction) and 11.0 ± 2.6 mm Hg in the MMC group (p < 0.01, 54% reduction). The surgical success rate 12 months after surgery was 93.3% in the MMC group and 40% in the OLO group (p = 0.01). CONCLUSIONS: With the atelocollagen-glycosaminoglycan matrix OLO it was not possible to reach the surgical success rate and pressure reduction achieved in the MMC group.