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

Background To assess the efficacy and safety of collagen matrix implant (Ologen) in phacotrabeculectomy. Design Prospective, non‐randomized, comparative study. Participants Sixty‐six Asian patients. Methods 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. Main Outcome Measures The primary outcome measure was postoperative intraocular pressure at month 12. Additional postoperative treatments, such as bleb needling, and adverse events were secondary outcomes. Results 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 (