Efficacy and Safety of Pairing iStent Inject Trabecular Micro-Bypass and iAccess Precision Blade Goniotomy in Patients with Open-Angle Glaucoma

INTRODUCTION: This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG). METHODS: This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1 month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries. RESULTS: In group A, mean IOP reduced from 14.9 ± 3.2 mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5 mmHg on 0.24 ± 0.61 medications at month 3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2 mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3 mmHg on 0.57 ± 1.27 medications at month 3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3 months, the percent of eyes with IOP ≤ 12 mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15 mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups. CONCLUSIONS: Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade.