Davinder S Grover1, William J Flynn2, Kent P Bashford3, Richard A Lewis4, Yi-Jing Duh5, Rupali S Nangia6, Barbara Niksch6. 1. Glaucoma Associates of Texas, Dallas, Texas. Electronic address: dgrover@glaucomaassociates.com. 2. Rashid, Rice, Flynn & Reilly Eye Associates, San Antonio, Texas. 3. Eye Center of Northern Colorado, Fort Collins, Colorado. 4. Sacramento Eye Consultants, Sacramento, California. 5. StatServe Consulting Inc, Chino Hills, California. 6. Allergan plc, Irvine, California.
Abstract
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 interno in patients who failed prior filtering/cilioablative procedure or had uncontrolled IOP on maximum-tolerated medical therapy, with medicated IOP ≥20 and ≤35 mmHg 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 IOP change from baseline at month 12. Procedure-related complications and ocular adverse events (AEs) were assessed. RESULTS: Sixty-five patients were implanted (intent-to-treat/safety population). At 12 months, 75.4% (46/61; observed data) reported ≥20% 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.
RCT Entities:
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 interno 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 IOP change from baseline at month 12. Procedure-related complications and ocular adverse events (AEs) were assessed. RESULTS: Sixty-five patients were implanted (intent-to-treat/safety population). At 12 months, 75.4% (46/61; observed data) reported ≥20% 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 glaucomapatients.
Authors: Michael M Lin; William H Morgan; Natasha N Kolomeyer; Stephen J Moster; Cindy X Zheng; Antonio Giubilato; Marlene R Moster Journal: J Glaucoma Date: 2019-12 Impact factor: 2.503
Authors: Anna Do; Elyse McGlumphy; Aakriti Shukla; Sonal Dangda; Joel S Schuman; Michael V Boland; Jithin Yohannan; Joseph F Panarelli; E Randy Craven Journal: Ophthalmol Glaucoma Date: 2020-12-13