Safety and efficacy of bilateral simultaneous XEN implant surgery: a pilot study

Objective To evaluate the efficacy and safety of the bilateral simultaneous XEN (BISIXEN) surgery in open-angle glaucoma patients. Methods Retrospective analysis of a prospective data base conducted on uncontrolled glaucoma patients who underwent BISIXEN surgery. Primary endpoint measure was the incidence of sight-threatening complications. Secondary endpoints included intraocular pressure (IOP) reduction and in number of required antiglaucoma medications. Results Ten patients (20 eyes) were included in the analysis. Median (95% confidence interval) follow-up was 12.0 (7.0–12.0) months, with 14 eyes having a follow-up of 12 months. No sight-threatening complications, such as endophthalmitis, retinal detachment, corneal decompensation, or intraocular hemorrhages were observed in any eye of study sample. Mean IOP decreased significantly from 25.2 (21.5–28.9) mm Hg at baseline to 15.1 (13.4–16.8) mm Hg at the last follow-up visit ( p = 0.0001). Mean number of antiglaucoma medications was significantly reduced from 2.9 (2.5 to 3.3) drugs at baseline to 0.40 (0.00–0.70) at the end of the study ( p < 0.0001). At the last study visit, 14 (70.0%) eyes had an IOP ≥ 6 and ≤ 18 mm Hg without treatment. Two eyes needed surgical revision and three ones needed a new glaucoma surgery: two underwent Ahmed valves (one eye with aniridia and the other previously operated on) and one underwent non-penetrating deep sclerectomy. Conclusions Bilateral simultaneous XEN implantation may be a feasible strategy in those patients with high anesthetic risk.