Third-Generation Trabecular Micro-Bypass Implantation and Phacoemulsification in Patients with Glaucoma: A Multicenter Study.

Abstract

This multicenter study evaluated the effectiveness and safety of third-generation trabecular micro-bypass implantation (iStent^® infinite) combined with phacoemulsification (n = 233 eyes). Key outcomes through 12 months included the mean change in intraocular pressure (IOP) and the number of topical medications, as well as proportions achieving IOPs ≤ 18/15/12 mmHg or using 0/1/2/ ≥ 3 medications. In all eyes with 12-month follow-up data (n = 96, consistent cohort), the mean IOP reduced from 17.2 ± 4.2 mmHg preoperatively to 13.8 ± 3.0 mmHg at Month 12 (p = 0.001), while the mean number of medications reduced from 1.24 ± 0.91 preoperatively to 0.61 ± 0.96 at Month 12 (p = 0.001). The proportions of eyes achieving IOP ≤ 18/15/12 mmHg increased from 63.5%, 34.4%, and 14.6% preoperatively to 92.7%, 71.9%, and 37.5%, respectively at Month 12, (all p = 0.001). The proportions of eyes off medication increased from 16.7% preoperatively to 62.5% at Month 12 (p = 0.001). This study provides clinically relevant, real-world results that demonstrate significant reductions in IOP and the number of topical glaucoma medications required following iStent infinite trabecular micro-bypass and phacoemulsification.