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

Abstract

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. 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. 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. XEN45 Gel Stent implant significantly reduced the intraocular pressure and the number of antiglaucoma medications in patients with pseudoexfoliative glaucoma.