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

摘要

IntroductionThe purpose of this study was to evaluate intraocular pressure (IOP) lowering and safety of XENsup?/sup stent in medically refractory, progressive, open-angle glaucoma (OAG). MethodsForty-seven eyes of 42 patients were treated with XENsup?/sup stent alone or combined with phacoemulsification. ResultsMean 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. ConclusionsXENsup?/sup stent is effective and relatively safe surgery for medically refractory, progressive, OAG out to 1?year. Intraocular pressure and medications were significantly reduced.