iStent Trabecular Micro-bypass Stent Implantation Combined with Phacoemulsification for Open-Angle Glaucoma: A 2-Year Post-marketing Surveillance Study in Japan

INTRODUCTION: We report 2-year outcomes after implantation of iStent trabecular micro-bypass stent with phacoemulsification, in Japanese patients with mild–moderate open-angle glaucoma (OAG). METHODS: This was a 24-month, prospective, longitudinal, observational, post-marketing study conducted between July 2017 and September 2020. Patients consisted of adults with OAG on antiglaucoma medications who had cataract surgery combined with one iStent implantation. Outcome measures included intraocular pressure (IOP), antiglaucoma medications, treatment success rates (defined as eyes having lower IOP with same or reduced number of medications from baseline, or same IOP with reduced number of medications from baseline, and not requiring secondary glaucoma surgeries postoperatively), and safety. Outcomes were analyzed in the overall cohort and in glaucoma subtypes: primary OAG, normal-tension glaucoma, and exfoliative glaucoma. RESULTS: Overall, 232 eyes were enrolled. At 24 months, mean ± standard deviation IOP decreased from 17.6 ± 4.0 mmHg preoperatively to 14.3 ± 3.0 mmHg (p < 0.05), and mean number of medications reduced from 2.2 ± 1.2 preoperatively to 0.7 ± 1.2 (p < 0.05). Similar trends were observed across glaucoma subtypes. In the overall cohort, 96.7%, 95.3%, and 93.7% of patients achieved treatment success at 6, 12, and 24 months, respectively. There were 67.6% medication-free eyes at 24 months compared to 3.2% medication-free eyes preoperatively (p < 0.0001). Safety profile was favorable over the 2-year period. CONCLUSIONS: Following iStent implantation with phacoemulsification, clinically relevant and statistically significant reductions in IOP and number of medications were observed in Japanese eyes with OAG over 2 years, with favorable safety profile. These reductions were observed across all glaucoma subtypes. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02207-0.