Second-generation trabecular micro-bypass stent implantation: Retrospective analysis after 12- and 24-month follow-up

The study aimed to investigate the 24-month safety and efficacy of implantation of two second-generation iStent inject trabecular micro-bypass stents with concomitant cataract surgery. This consecutive case series included 164 eyes of 109 patients implanted with the iStent inject® device with concomitant cataract surgery. The series was comprised of eyes with primary open-angle glaucoma ( = 84), pseudoexfoliation glaucoma ( = 42), normal-tension glaucoma ( = 18), and ocular hypertension ( = 20). All 164 eyes reached 9-14 months of follow-up ("12-month consistent cohort"), with a subset of 88 eyes reaching 21-26 months of follow-up ("24-month consistent cohort"). Performance outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included intra- or postoperative complications, the need for secondary procedures and corrected distance visual acuity. Comparisons of change in continuous (e.g., IOP) and categorical (e.g., proportions of eyes on zero medications) measures between baseline and postoperative times were made with the paired t-test and McNemar's chi-squared test, respectively. At 12 months postoperatively, IOP was reduced by 25.5% (from 20.0 ± 5.5 mmHg to 14.9 ± 2.0 mmHg;