Third-Generation Trabecular Micro-Bypass Implantation with Phacoemulsification for Glaucoma.

Introduction: This retrospective, consecutive, real-world case series assessed the efficacy and safety of third-generation trabecular micro-bypass stent implantation (iStent infinite) with phacoemulsification in patients with mild-to-moderate primary open-angle glaucoma (POAG).

Methods: Patients underwent phacoemulsification combined with implantation of iStent infinite (containing three stents) by a single U.S. glaucoma surgeon. Outcomes through 12 months included mean intraocular pressure (IOP) and medications; proportions of eyes with IOP ≤ 18 mmHg, ≤ 15 mmHg, or ≤ 12 mmHg; proportions of eyes on 0, 1, 2, or ≥ 3 topical glaucoma medications; adverse events; and secondary glaucoma procedures. Data are presented for the observed cohort of all available eyes at each time point and the consistent cohort of eyes with data at 12 months postoperative.

Results: A total of 121 eyes with mild (66.1%) or moderate (33.9%) POAG underwent iStent infinite implantation between February 2023 and June 2024. In eyes with 12-month follow-up data (n = 32), mean IOP reduced from 18.1 ± 3.3 mmHg preoperatively to 13.8 ± 3.4 mmHg at 12 months (23.8% reduction, p < 0.001), while mean number of medications reduced from 1.38 ± 0.91 to 1.06 ± 1.13 medications (23.2% reduction, p = 0.023). The proportions of eyes achieving IOP ≤ 18/15/12 mmHg increased from 53.1%/21.9%/3.1% preoperatively to 87.5%/75.0%/43.8% at 12 months, respectively (all p < 0.01). Adverse events were largely mild and transient; three eyes (< 3%) had secondary laser or micro-invasive glaucoma interventions due to IOP and/or medications above goal.

Conclusions: iStent infinite implantation with cataract surgery resulted in clinically and statistically significant IOP and medication reductions through 12 months postoperative, with favorable safety. This cohort constitutes one of the first and largest published datasets for this device in combination with cataract surgery in real-world usage.