Clinical Impact of the Use of Ologen in Filtering Surgery Performed in Uncontrolled Glaucoma

Abstract

Introduction: To compare the efficacy and safety of trabeculectomy with a collagen matrix implant (Ologen (R)) versus trabeculectomy with mitomycin C (MMC) versus trabeculectomy with both Ologen (R) 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. The data were initially recorded following a standard surgical protocol, using an electronic database with structured fields. The patients were divided into three groups: 44 received trabeculectomy with adjunctive MMC (MMC group), 34 received surgery with Ologen (R) (OLO group), and 41 received surgery with both Ologen (R) 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: IOPs 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 the baseline IOP, only the first two postoperative visits (first week and first month) showed a 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). The 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 between 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 observed in the OLO + MMC group. Conclusions: The use of Ologen (R) and mitomycin C provided similar surgical IOP reduction in glaucoma surgery compared with either MMC or Ologen (R) alone, but significantly reduced the need for postoperative interventions.