iStent inject Trabecular Micro-Bypass with or Without Cataract Surgery Yields Sustained 5-Year Glaucoma Control

Abstract

Introduction: This study evaluated the 5-year effectiveness and safety of iStent inject® trabecular micro-bypass with or without cataract surgery (Combined or Standalone, respectively) in patients with open-angle glaucoma (OAG). Methods: This prospective longitudinal case series included consecutive iStent inject cases from a single surgeon at a large German academic hospital. Intraocular pressure (IOP), medications, safety, and indicators of disease stability through 5 years were assessed in the Overall cohort and in subgroup analyses stratified by usage (Combined or Standalone). Results: Preoperative mean IOP in the Overall cohort (n = 125) was 23.5 ± 6.2 mmHg on 2.68 ± 1.02 mean medications, reducing to 14.1 ± 1.8 mmHg on 0.77 ± 0.82 medications at 5 years (40% and 71% reductions, respectively; both p < 0.001). All but 1 eye (> 99%) were on medication(s) preoperatively, but 46% were medication-free at 5 years (p < 0.001). In Combined eyes (n = 81), mean IOP decreased by 39% (22.6 mmHg to 13.8 mmHg, p < 0.001) and medications by 69% (2.52 to 0.78, p < 0.001). In Standalone eyes, mean IOP reduced by 42% (25.3 mmHg to 14.6 mmHg, p < 0.001) and medications by 75% (2.98 to 0.74, p < 0.001). At final follow-up, 83% of eyes had achieved ≥ 20% IOP reduction, and all but 1 eye (> 99%) had the same or lower IOP versus preoperative; all eyes (100%) maintained or reduced their medication burden versus preoperative. Favorable safety included 0 intraoperative complications and 0 filtration surgeries through 5 years. Long-term indicators of disease stability (visual fields, retinal nerve-fiber layer thickness, and cup:disc ratio) were unchanged over the course of 5-year follow-up. Conclusions: iStent inject produced significant and durable 5-year reductions in IOP (nearly 10-mmHg reduction) and medications (nearly 2-medication reduction), with stable disease parameters over time. Combined and Standalone subgroups had similar outcomes.