Background: Minimally invasive glaucoma surgery (MIGS) has become more widespread in open-angle glaucoma (OAG) management. Broad evidence has shown a greater decrease in mean intraocular pressure (IOP) when cataract surgery is combined with MIGS, compared with cataract surgery alone. In this study, we evaluated the effectiveness and safety of second-generation trabecular micro-bypass implantation (iStent inject®) either in combination with cataract surgery (Combined subgroup) or as a standalone procedure (Standalone subgroup) in eyes with OAG. Our hypothesis was that implementing interventional glaucoma management would provide meaningful reductions in IOP and topical medication burden.

Methods: This long-term retrospective consecutive case series included patients with mild to moderate OAG who received the iStent inject® Trabecular Micro-bypass stent with or without phacoemulsification between 2018 and 2024. Eligible patients were ≥ 18 years of age with mild or moderate OAG, cataract requiring surgery (for the Combined subgroup), and the need for IOP and/or medication reduction. Study outcomes included mean and proportional analyses of IOP and medications over time. Analyses were completed for the overall population and for the Combined/Standalone and Mild/Moderate subgroups.

Results: The study included 271 eyes with mean age 69 years and a mean of 40 months of follow-up (range 10-79 months). In the overall population, mean IOP decreased from 16.4 mmHg at baseline to 13.7 mmHg at last follow-up (p = 0.001), while the mean number of medications decreased from 2.24 at baseline to 0.62 at last follow-up (p = 0.001). IOP reductions were also significant in the Combined/Standalone subgroups and in the Mild/Moderate subgroups (p = 0.001 for all), and all subgroups experienced increased proportions of eyes on no topical medications at last follow-up versus preoperative (p = 0.001 for all).

Conclusions: This 5-year real-world study showed significant and sustained reductions in IOP and topical medication burden following iStent inject trabecular micro-bypass with or without cataract surgery in eyes with mild and moderate open-angle glaucoma.