Efficacy and safety of collagen matrix implants in phacotrabeculectomy and comparison with mitomycin C augmented phacotrabeculectomy at 1 year

Abstract

To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. Prospective, non-randomized, comparative study. Sixty-six Asian patients. Thirty three consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin C augmentation. The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. The overall percentage reduction in intraocular pressure was 13% (95% confidence interval 6.7-19.2) in the Ologen group and 26% (95% confidence interval 14.8-37.9) in the mitomycin C group (P = 0.05). At 1 year after surgery (after adjusting for baseline differences), intraocular pressure decreased by 4.2 mmHg (95% confidence interval 2.8-5.6 mmHg) and 5.6 mmHg (95% confidence interval 4.2-7.0 mmHg), respectively (P = 0.16). Needling with 5-fluorouracil was required more often in the Ologen group (39% vs. 6%; P = 0.003). There was similar frequency (<10%) of adverse events in both groups, and there were no complications directly related to the Ologen implant. The blebs in the mitomycin C group had greater central area (P = 0.005), maximal area (P = 0.01) and height (P = 0.005), and were less vascular (P = 0.023) than the Ologen blebs. At 1 year, the overall performance of Ologen in combined phacotrabeculectomy was suboptimal compared with combined surgery with mitomycin C. Eyes in the Ologen group required more frequent bleb needling procedures.