Three-Year Outcomes of Second-generation Trabecular Micro-bypass Stents (iStent inject) With Phacoemulsification in Various Glaucoma Subtypes and Severities.

Abstract

This longitudinal case series provides valuable long-term data on the safety and efficacy of iStent inject with concomitant cataract surgery. Patients experienced significant and durable reductions in both intraocular pressure (IOP) and medication burden through 3 years postoperative. The purpose of this study was to examine the 3-year effectiveness and safety of iStent inject second-generation trabecular micro-bypass stent implantation with concomitant phacoemulsification cataract surgery in eyes with various glaucoma subtypes and severities. This was a single-center consecutive case series. Three-year outcomes included mean IOP and medications, the proportions of eyes with IOP ≤18, ≤15, and ≤12 mm Hg, and success (absence of secondary glaucoma interventions). Safety included best-corrected visual acuity (BCVA), cup-to-disc ratio, visual field (VF) mean deviation, retinal nerve fiber layer (RNFL), and ganglion cell-inner plexiform layer (GCIPL) thickness, and adverse events. A total of 124 eyes with different glaucoma subtypes and severities were included. At 3 years postoperative, mean IOP reduced from 16.90±3.85 mm Hg preoperatively to 13.17±2.83 mm Hg (22% reduction, P<0.001) and mean medication burden decreased from 2.38±1.29 medications preoperatively to 1.16±1.22 medications (51% reduction, P<0.001). At 3 years, 96% of eyes achieved IOP ≤18 mm Hg (vs. 69% preoperatively), 80% of eyes achieved IOP ≤15 mm Hg (vs. 40% preoperatively), and 42% of eyes achieved IOP ≤12 mm Hg (vs. 7% preoperatively) with 76% of eyes eliminating ≥1 medication and 37% of eyes eliminating ≥2 medications versus preoperative medication burden. The 3-year cumulative survival rate was 74%. Postphacoemulsification BCVA improvement was preserved, and cup-to-disc ratio, VF mean deviation, and RNFL and GCIPL thickness remained stable. A favorable safety profile included no intraoperative complications and few, transient, postoperative adverse events. Significant and sustained IOP and medication reductions were achieved through 3 years after iStent inject implantation with cataract surgery in a real-world clinical population with mild-to-severe glaucoma, along with favorable safety including stable BCVA, VF, and RNFL and GCIPL thickness.