XEN® Gel Stent in Medically Refractory Open-Angle Glaucoma: Results and Observations After One Year of Use in the United States

Introduction The purpose of this study was to evaluate intraocular pressure (IOP) lowering and safety of XEN (R) stent in medically refractory, progressive, open-angle glaucoma (OAG). Methods Forty-seven eyes of 42 patients were treated with XEN (R) stent alone or combined with phacoemulsification. Results Mean IOP decreased from 22.34 +/- 7.34 mmHg to 12.91 +/- 4.21, 12.95 +/- 4.36, 13.49 +/- 3.91, and 13.36 +/- 3.63 mmHg at 1, 3, 6, and 12 months (95% confidence interval [CI] [20.24, 24.44], [11.71, 14.12], [11.63, 14.27], [12.36, 14.62], and [12.10, 14.62]), respectively. Mean number of medications decreased from 2.96 +/- 1.20 (95% CI [2.62, 3.30]) at baseline to 0.75 +/- 1.27 (95% CI [0.31, 1.19]) at 1 year. At 1 year (n = 32), complete success was achieved in 68.8% (n = 22/32) (i.e., IOP reduction >= 20% and IOP < 18 mmHg without medication or any secondary glaucoma intervention). Qualified success was achieved in 90.6% (n = 29/32) (i.e., IOP reduction of >= 20% and IOP < 18 mmHg with and without medication or any secondary glaucoma intervention). Eleven eyes had not yet reached 12 months. Two patients (three eyes) died before 1 year; one patient (one eye) was lost to follow up. Adverse events: localized choroidal hemorrhage in one eye; hypotony (IOP < 6 mmHg) at day 1 in 10 eyes, with full resolution by 2 weeks. No persistent hypotony or maculopathy occurred. Stent erosion with removal occurred in two eyes. Fourteen eyes (29.8%) underwent needling. One patient required trabeculectomy. Conclusions XEN (R) stent is effective and relatively safe surgery for medically refractory, progressive, OAG out to 1 year. Intraocular pressure and medications were significantly reduced.