Prospective, Multicenter, Single-Arm, Open-Label Study of the Safety and Effectiveness of the Gel Stent in Angle Closure Glaucoma.

PURPOSE: 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.