Sustained 36-month IOP and medication reductions were achieved with the second generation Trabecular Micro-Bypass (iStent Inject) plus phacoemulsification, with clinically and statistically greater IOP reduction vs phaco alone, according to a recent poster presentation at 2020 AAO Virtual.
The study assessed long-term outcomes of the microinvasive glaucoma surgery (MIGS) device (iStent inject, Glaukos Corp.) + phaco vs phaco alone in primary open angle glaucoma (POAG) patients from the pivotal iStent inject randomized controlled clinical trial (RCT). From the pivotal RCT, 136 iStent inject (INJ) and 40 phaco alone (CS) patients were followed for an additional 36-month visit and completed all visits. Results at 36 months postop demonstrated mean IOP in med-free eyes was 15.9 ± 2.75 mm Hg in INJ (n=98) and 16.7 ± 2.58 mm Hg in CS (n=24) eyes. Overall medication-free IOP reduction was significantly greater in INJ (−8.0 ± 3.2 mm Hg) than CS (−6.2 ± 2.31 mm Hg) eyes. Also, more INJ eyes than CS eyes had clinically meaningful 36-month medication-free IOP reductions vs baseline: 47.1% vs 27.5% with ≥30% reduction, and 64.7% vs 47.5% with ≥20% reduction, respectively. Eyes that received the device had greater improvements in patient quality of life, had additional risk of safety concerns vs cataract surgery alone, had a lower rate of secondary glaucoma surgery.
Samuelson TW. Three-year pivotal trial outcomes of iStent Inject Trabecular Micro-Bypass + phacoemulsification vs phaco alone in POAG. Presented at: AAO 2020 Virtual [Session: PO185].