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.