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

Abstract

Abstract Background 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. Methods 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 (n = 84), pseudoexfoliation glaucoma (n = 42), normal-tension glaucoma (n = 18), and ocular hypertension (n = 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. Results At 12 months postoperatively, IOP was reduced by 25.5% (from 20.0 ± 5.5 mmHg to 14.9 ± 2.0 mmHg; p < 0.001); at 24 months postoperatively, IOP was reduced by 26.6% (from 20.3 ± 6.1 mmHg to 14.9 ± 1.9 mmHg; p < 0.001). At 12 months postoperatively, mean number of glaucoma medications was reduced by 85.0% (from 2.0 ± 1.0 to 0.3 ± 0.8 medications; p < 0.001); at 24 months postoperatively, mean number of medications was reduced by 81.0% (from 2.1 ± 1.1 to 0.4 ± 0.8 medications; p < 0.001). After 12 months, 96.3% of eyes had an IOP ≤ 18 mmHg and 58.5% of eyes had an IOP ≤ 15 mmHg, with 81.1% of eyes free of any medication, compared to 1.8% of eyes medication-free in the 12-month cohort at baseline. After 24 months, 98.9% of eyes had an IOP ≤ 18 mmHg and 53.4% of eyes had an IOP ≤ 15 mmHg, with 72.7% free of medication compared to 1.1% of eyes medication-free in the 24-month cohort at baseline. Overall, a high safety profile was observed with no significant postoperative complications. Conclusions The insertion of iStent inject (comprised of two second-generation trabecular micro-bypass stents) with cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden up to 24 months postoperatively.