Efficacy and Safety of the iStent infinite Trabecular Micro-Bypass Device for Glaucoma: A Systematic Review and...

The iStent infinite (Glaukos Corporation) is a third-generation trabecular micro-bypass device approved for stand-alone use in patients with inadequately controlled open-angle glaucoma, but overall efficacy and safety estimates have not been quantitatively synthesized via meta-analysis. Our objective was to evaluate the 12-month efficacy and safety of iStent infinite device implantation by examining intraocular pressure reduction and glaucoma medication reduction.

We conducted a systematic review and meta-analysis per the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 guidelines after registering the review protocol with the International Prospective Register of Systematic Reviews (PROSPERO). We searched PubMed/MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and ClinicalTrials.gov from inception through November 2025 for studies reporting 12-month outcomes after iStent infinite device implantation (stand-alone or combined with phacoemulsification). Pooled mean changes in intraocular pressure and medications were calculated, heterogeneity was assessed with I², and surgical approach (stand-alone vs combined with phacoemulsification) was evaluated via meta-regression.

Three nonrandomized studies comprising 199 eyes with 12-month follow-up were included. The pooled mean intraocular pressure reduction at 12 months was 4.48 mm Hg (95% CI 3.04 to 5.92; P<0.0001) with high heterogeneity (I²=83.4%). Meta-regression showed greater intraocular pressure reduction with stand-alone implantation vs phacoemulsification-combined procedures (an additional 2.16 mm Hg; 95% CI 0.52 to 3.81; P=0.010), explaining 88.4% of heterogeneity. The pooled mean reduction in glaucoma medications was 0.48 (95% CI 0.29 to 0.67; P<0.0001) with moderate heterogeneity (I²=45.0%) and no significant difference by surgical approach (P=0.65).

iStent infinite device implantation was associated with clinically meaningful 12-month reductions in intraocular pressure, a modest reduction in medication burden, and a favorable short-term safety profile.