Performance and Safety of a New Ab Intern Gelatin Stent in Refractory Glaucoma at 12 Months

PURPOSE: To evaluate the intraocular pressure (IOP)lowering performance and safety of an ab interno gelatin stent (XEN 45 Gel Stent, Allergan plc, Irvine, California, USA), a minimally invasive glaucoma surgery device, in refractory glaucoma. DESIGN: Single-arm, open-label, multicenter clinical study. METHODS: Following mitomycin C pretreatment, the stent was placed ab intern in patients who failed prior filtering/cilioablative procedure or had uncontrolled IOP on maximum-tolerated medical therapy, with medicated IOP >= 20 and <= 35 mm Hg and visual field mean deviation <=-3 dB. Primary performance outcomes: patients (%) achieving >= 20% IOP reduction from baseline on the same or fewer medications and mean lop change from baseline at month 12. Procedure-related complications and ocular adverse events (AEs) were assessed. RESULTS: Sixty-five patients were implanted (intentto-treat/safety population). At 12 months, 75.4% (46/61; observed data) reported >= 2.0% IOP lowering from baseline on the same or fewer medications. Mean IOP change from baseline was -9.1 mm Hg (95% confidence interval [CI]: -10.7, -7.5) (n = 52; observed data) at 12 months, excluding patients with missing data (n = 4) and those requiring a glaucoma-related secondary surgical intervention (n = 9). Mean medication count decreased from 3.5 (baseline) to 1.7 (12 months). No intraoperative complications or unexpected postoperative AEs were reported. Most AEs were mild/moderate; common AEs included needling (without sight threatening complications), nonpersistent loss of best corrected visual acuity, and transient hypotony (requiring no surgical intervention). CONCLUSIONS: The gelatin stent reduced IOP and medication use without raising unexpected safety concerns, offering a minimally invasive surgical option for refractory glaucoma patients. (C) 2017 The Authors. Published by Elsevier Inc.