Clinical Impact of the Use of Ologen in Filtering Surgery

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Purpose: To compare the efficacy and safety of trabeculectomy with a collagen matrix implant (Ologen®) versus trabeculectomy with mitomycin C (MMC) versus trabeculectomy with both Ologen® and MMC (OLO+MMC). Methods: This non-randomized study included 119 eyes of 101 patients with uncontrolled open-angle glaucoma who underwent trabeculectomy, either alone or combined with phacoemulsification. Data were initially registered following a standard surgical protocol and using an electronic database with structured fields. Patients were divided into three groups: 44 received trabeculectomy with adjunctive MMC (MMC group), 34 with Ologen® (OLO group), and 41 with both Ologen® and MMC (OLO+MMC group). The main outcome measures were the change in intraocular pressure (IOP), change in number of medications needed, complete success rate (defined as IOP≤20 mmHg and at least 20% IOP reduction without hypotensive medications), rate of complications, and rate of postoperative interventions. The follow-up period was 36 months. Results: IOP significantly decreased (p=0,01) in all groups across all study visits, decreasing from 19.8 ± 4.6 mmHg to 12.7 ± 4.2 mmHg in the MMC group, from 20.5 ± 4.7 mmHg to 13.9 ± 3.5 mmHg in the OLO group, and from 23.5 ± 6.1 mmHg to 13.1 ± 3.5 mmHg in the OLO+MMC group. After correcting for baseline IOP, only the first two postoperative visits (first week and first month) showed significantly greater IOP reduction in the OLO+MMC group. The number of hypotensive medications was significantly reduced from 3.1±0.6 to 0.56±1.1 in the MMC group, from 2.9±0.4 to 0.83±1.1 in the OLO group, and from 3.0±0.6 to 0.45±0.95 in OLO + MMC group, with no statistically significant differences among the groups (p=0,57). Complete success rates were 63,6% in the MMC group, 67,6% in the OLO group, and 80,5% in the OLO +MMC group, with no statistically significant differences among the groups (p=0,21). Suture release was significantly more frequent in the MMC group (86,1%) than in the OLO group (62,1%) and in the OLO + MMC group (45,9%; p=0,02). Bleb needling, with (33.3%; p=0.005) or without (66.7%; p=0.0001) 5-Fluorouracil injection (5-FU), was significantly more common in the MMC group. The highest complete-success rate (61%) was offered by the OLO+MMC group. Conclusion: The use of Ologen® and Mitomycin C provided similar surgical IOP reduction in glaucoma surgery compared with MMC or Ologen® either alone but significantly reduced the need for postoperative interventions.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.