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

• Published in: American journal of ophthalmology Vol. 183; pp. 25 - 36
• Main Authors: Grover, Davinder S., Flynn, William J., Bashford, Kent P., Lewis, Richard A., Duh, Yi-Jing, Nangia, Rupali S., Niksch, Barbara
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-11-2017; Elsevier Limited
• Subjects: Aged; Cataracts; Clinical outcomes; Diabetic retinopathy; Eye surgery; FDA approval; Female; Filtering Surgery - methods; Follow-Up Studies; Gelatin; Glaucoma; Glaucoma Drainage Implants; Glaucoma, Open-Angle - diagnosis; Glaucoma, Open-Angle - physiopathology; Glaucoma, Open-Angle - surgery; Gonioscopy; Humans; Intraocular Pressure; Male; Middle Aged; Ophthalmology; Patients; Prospective Studies; Prosthesis Design; Stents; Time Factors; Trabecular Meshwork - pathology; Transplants & implants; Treatment Outcome; Visual Fields - physiology; United States > US; California
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2017.07.023

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.
Single-arm, open-label, multicenter clinical study.
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.
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).
The gelatin stent reduced IOP and medication use without raising unexpected safety concerns, offering a minimally invasive surgical option for refractory glaucoma patients.