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

Abstract

To evaluate the efficacy and safety of the bilateral simultaneous XEN (BISIXEN) surgery in open-angle glaucoma patients. 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. 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 12months. 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 ≤ 18mm 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. Bilateral simultaneous XEN implantation may be a feasible strategy in those patients with high anesthetic risk.