Standalone iStent infinite surgery achieves clinically significant IOP reduction in uncontrolled glaucoma
The iStent infinite Trabecular Micro-Bypass System is an effective and safe treatment option for patients with open-angle glaucoma (OAG) that is uncontrolled by prior surgical or medical therapy, according to study results presented at ASCRS 2023.
In this prospective, multicenter, single-arm, open-label pivotal trial that evaluated the safety and effectiveness of the iStent infinite system in this patient population, 72 eyes of 72 patients, with a mean age of 71.9 years were included. Prior to the surgery, the patients had a mean medicated mean diurnal intraocular pressure (MDIOP) of 23.4±2.8 mmHg on a mean of 3.1±0.9 IOP-lowering medications.
The primary effectiveness endpoint of the study was the proportion of eyes achieving ≥20% MDIOP reduction from baseline at Month 12 on the same or fewer IOP-lowering medication classes (responder endpoint), as well as the mean change in MDIOP from baseline at Month 12.
Overall, 76.1% of enrolled patients met the responder endpoint, with a mean reduction in MDIOP at 12 months of 5.9(0.6) mmHg. For patients on the same or fewer medications as baseline, 53.0% achieved ≥30% MDIOP reduction without surgical interventions or other events.
Safety was favorable, with no explants or infection, and no device-related interventions, hypotony, or significant vision loss.
IK Ahmed. Prospective Study of Standalone Multiple Trabecular Micro-Bypass Stents for Uncontrolled Glaucoma. Presented at: ASCRS 2023.