Prospective, Multicenter, Single-Arm, Open-Label Study of the Safety and Effectiveness of the Gel Stent in Angle Closure Glaucoma
Michael Coote, Nathan Kerr, Paul Harasymowycz, Chelvin C.A. Sng, Katherine W.X. Lun, Yuen-Chieh Lee, Saumya Nagar, Daisy Yuan, Eleonora Safyan, Michael R. Robinson, Susan S. LeePurpose:
To evaluate the gel stent’s intraocular pressure (IOP)-lowering safety and effectiveness in angle closure glaucoma (ACG).
Methods:
Prospective, multicenter, nonrandomized, 12-month, interventional study. Adults with ACG (iridotrabecular contact in ≥2 quadrants, glaucomatous optic disc damage, and visual field loss) and baseline IOP 20–35 mmHg received ab-interno gel stent implantation on Day 1. The primary endpoint was the proportion of patients achieving ≥20% IOP reduction from baseline without IOP-lowering medication increase at Month 12.
Results:
Of 62 patients/eyes enrolled and implanted, 45 (72.6%) had a history of glaucoma procedures, 50 (80.6%) underwent ≥1 concomitant angle-widening procedure(s) (usually cataract surgery), and 59 (95.2%) completed the study. Baseline IOP was 24.0 mmHg on 2.3 IOP-lowering medications (mean). At Month 12, 80.5% (95% confidence interval [CI]: 68.4–88.8) of patients achieved the primary endpoint, with similar proportions in the presence (81.8%; 95% CI: 67.3–91.8) and absence (83.3%; 95% CI: 51.6–97.9) of concomitant angle-widening procedures. Month 12 mean changes from baseline in IOP and number of IOP-lowering medications were −8.9 mmHg (95% CI: −10.2 to −7.6) and −1.6 (95% CI: −1.9 to −1.2), respectively. Twenty-one eyes (33.9%) required needling. There were no surgical complications. Serious postoperative ocular adverse events occurred in 6 (9.7%) study eyes; all resolved without sequelae.
Conclusion:
Gel stent implantation had an acceptable safety profile and effectively lowered IOP and the medication burden in ACG.