Purpose: The aim of this study was to compare the efficacy and safety of the XEN45 gel stent implant in patients with primary open-angle glaucoma or secondary open-angle glaucoma. Patients and methods: This is a retrospective, single-center, and comparative study conducted in consecutive primary open-angle glaucoma or secondary open-angle glaucoma patients, who underwent a XEN45 implant, alone or in combination with phacoemulsification. The primary end point was the intraocular pressure at the end of the follow-up period. Complete success was defined as an intraocular pressure reduction of ⩾20% from baseline to month 12 without antiglaucoma treatment. Results: Of the 69 patients (74 eyes) who were screened, 68 patients (73 eyes) were included in this study. In the overall study population, XEN gel stent significantly reduced intraocular pressure from 22.3 (21.0–23.5) mmHg at baseline to 15.3 (14.3–16.3) mmHg, p < 0.0001. As compared to baseline, mean intraocular pressure reduction was –7.3 (−9.7 to −5.0) and –6.6 (−8.4 to −4.8) mmHg in the primary open-angle glaucoma and secondary open-angle glaucoma groups, respectively, p = 0.6357. At month 12, 53 (72.6%) eyes were classified as success. The mean number of antiglaucoma medications was significantly reduced in both groups ( p < 0.0001, each). Complications included anterior chamber flattening (one eye), XEN implant extrusion (four eyes), one of whom had an endophthalmitis that required vitrectomy, and one eye underwent a trabeculectomy due to inadequate intraocular pressure control. Conclusion: XEN gel stent, either alone or in combination with phacoemulsification, provided a significant reduction in both intraocular pressure and medical antiglaucoma treatment, but with some safety concerns, in a cohort of patients with open-angle glaucoma (primary or secondary).
Efficacy and safety at 6 months of the XEN implant for the management of open angle glaucoma
