PURPOSE: To compare the efficacy and safety of collagen matrix implant (Ologen® ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. METHODS: Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned toOLO and 26 to MMC. The follow-up was 12 months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12 months. The secondary outcome measures were cumulative success rates at 12 months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. RESULTS: The mean IOP decreased from 26.4 ± 6.1 mmHg to 13.7 ± 3.8 in the OLO group and from 23.4 ± 3.6 mmHg to 13.3 ± 2.8 in the MMC group at 1 year without significant intergroup differences. At 1 year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. CONCLUSION:Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.
RCT Entities:
PURPOSE: To compare the efficacy and safety of collagen matrix implant (Ologen® ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. METHODS: Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned to OLO and 26 to MMC. The follow-up was 12 months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12 months. The secondary outcome measures were cumulative success rates at 12 months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. RESULTS: The mean IOP decreased from 26.4 ± 6.1 mmHg to 13.7 ± 3.8 in the OLO group and from 23.4 ± 3.6 mmHg to 13.3 ± 2.8 in the MMC group at 1 year without significant intergroup differences. At 1 year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. CONCLUSION: Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.