XEN implant in primary and secondary open-angle glaucoma: A 12-month retrospective study.

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).

One-year follow-up of the XEN® implant with mitomycin-C in pseudoexfoliative glaucoma patients.

PURPOSE: To evaluate the intraocular pressure-lowering effect, the safety profile, and the success rate of the XEN45 Gel Stent (Allergan, Dublin, Ireland) in patients with pseudoexfoliative glaucoma. METHODS: Retrospective study conducted on patients with pseudoexfoliative glaucoma, with or without cataract, who underwent XEN45 implantation surgery with subconjunctival mitomycin-C and had a minimum postoperative follow-up period of 12 months. The primary outcome measure was intraocular pressure reduction at 1 year as compared to baseline. Complete success was defined as a postoperative intraocular pressure reduction of ⩾20% from preoperative baseline at 12 months without any glaucoma medications. Qualified success was defined as a postoperative intraocular pressure reduction of ⩾20% at 12 months with medications. RESULTS: Of the 24 screened patients, 21 eyes of 20 patients met the inclusion/exclusion criteria and were included in the study. A total of 13 (62%) eyes underwent XEN alone surgery and 8 (38%) eyes had combined XEN + cataract surgery. Mean intraocular pressure was significantly reduced from 21.1 (3.8) mmHg at baseline to 15.2 (3.9) mmHg at 1 year, p < 0.001. Mean antiglaucoma medications dropped from 2.95 (0.97) preoperatively to 1.23 (1.22) at month 12 (p < 0.001). Of the 21 eyes included in the study, 18 (85.7%) were considered as success, 6 (28.6%) as complete success, and 12 (57.1%) as qualified success. Five eyes required needling revision. Complications included uveitis, choroidal detachment, hyphema, and cystoid macular edema in 2, 1, 1, and 1 eye, respectively. CONCLUSION: XEN45 Gel Stent implant significantly reduced the intraocular pressure and the number of antiglaucoma medications in patients with pseudoexfoliative glaucoma.