Abstract
Purpose :
To report the intraocular pressure (IOP)-lowering effectiveness and safety of the gel stent in phakic patients with angle closure glaucoma (ACG) who also had angle-widening procedures (Group 1), and phakic (Group 2) and pseudophakic (Group 3) patients with ACG who did not have angle-widening procedures.
Methods :
Eligible adults had ACG (ie, iridotrabecular contact in ≥2 quadrants, glaucomatous damage to the optic disc, and visual field loss); IOP 20-35 mmHg with medications and/or prior failed glaucoma surgery; and healthy/mobile conjunctiva in the target quadrant. Angle-widening procedures were permitted before ab-interno gel stent placement. Primary effectiveness endpoint: patients (%) achieving ≥20% IOP reduction from baseline at Month 12 without IOP-lowering medication increase (vs medically/surgically treated baseline). Key secondary effectiveness endpoints: mean IOP and medication count over time and changes from baseline. Safety endpoints included surgical complications and postoperative adverse events (AEs).
Results :
Of 62 patients/eyes enrolled and implanted, 50 (80.6%), 4 (6.5%), and 8 (12.9%) were in Groups 1, 2, and 3, respectively. The overall study completion rate was 95.2% (n=59/62). At baseline in Groups 1, 2, and 3, IOP was 23.8 (4.2), 26.1 (6.6), and 24.3 (4.0) mmHg on 2.3 (1.4), 2.5 (1.7), and 2.3 (1.6) IOP-lowering medications (means [SDs]), respectively. At Month 12 in those respective groups, 81.8% (95% CI, 67.3, 91.8), 75.0% (19.4, 99.4), and 87.5% (47.3, 99.7) of patients achieved the primary endpoint. The mean IOP reduction from baseline was -8.8 (95% CI, -10.2, -7.3; P<.01), -9.5 (95% CI, -20.9, 1.9), and -9.7 (95% CI, -13.0, -6.3; P<.01) mmHg. The mean IOP-lowering medication reduction was -1.5 (95% CI, -1.9, -1.1; P<.01), -1.8 (95% CI, -4.1, 0.6), and -1.9 (95% CI, -3.0, -0.7; P<.01). Overall, there were no surgical complications. Five (8.1%) study eyes had a serious postoperative ocular AE; all were resolved without sequalae, and none were unexpected.
Conclusions :
Gel stent implantation effectively lowered IOP and the medication burden similarly in Groups 1, 2, and 3, with an acceptable safety profile. The mean change from baseline in IOP and medication number did not reach statistical significance in Group 2, possibly due to its small size (n=4).
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.