Background: The study aimed to investigate the 24-month safety and efficacy of implantation of two secondgeneration 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.
Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial assistance in the preparation of the manuscript.
Lens epithelial cell proliferation was mild and confined to the periphery of the capsular bag during follow-up, and the bag-in-the-lens IOL optic remained clear.
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