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See also comment(s) by Jeffrey Liebmann •
BACKGROUND: To assess the efficacy and safety of collagen matrix implant (Ologen (TM) ) in phacotrabeculectomy surgeries in patients with primary glaucoma. DESIGN: Prospective, non-randomized, comparative study. PARTICIPANTS: Sixty-six Asian patients undergoing phacotrabeculectomy. METHODS: One eye of 33 consecutive patients underwent phacotrabeculectomy with Ologen implant and intraocular lens implantation, and 33 subjects recruited as controls underwent surgery with mitomycin-C (MMC) augmentation. MAIN OUTCOME MEASURES: The primary outcome measure was post-operative intraocular pressure (IOP) at Month 12, with comparisons made for absolute and percentage change in IOP from baseline. Additional post-operative treatments such as bleb needling, and adverse events were secondary outcomes. RESULTS: The overall percentage reduction in IOP was 13% (95%CI: 6.7-19.2) in the Ologen group and 26% (95%CI: 14.8-37.9) in the MMC group (p=0.05). At one year after surgery (after adjusting for baseline differences), IOP decreased by 4.2 mm Hg (95%Confidence Interval [CI]:2.8-5.6 mm Hg) and 5.6 mm Hg (95%CI: 4.2-7.0 mm Hg) 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 MMC group had greater central area (p=0.005), maximal area (p=0.01), height (p=0.005) and were less vascular (p=0.023) than the Ologen blebs. CONCLUSIONS: At one year, the overall performance of Ologen in combined phacotrabeculectomy was sub-optimal compared to combined surgery with MMC. Eyes in the Ologen group required more frequent bleb needling procedures.
Singapore National Eye Centre & Singapore Eye Research Institute, Singapore.
Full article12.8.10 Woundhealing antifibrosis (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
12.14.3 Phacoemulsification (Part of: 12 Surgical treatment > 12.14 Combined cataract extraction and glaucoma surgery)