iStent Inject Shows Sustained Intraocular Pressure Reduction Capability

For patients with primary open angle glaucoma, iStent Inject plus phacoemulsification demonstrated sustained 36-month intraocular pressure (IOP) reductions compared with phacoemulsification alone. This is according to data presented at the American Academy of Ophthalmology 2020 Annual Meeting, held virtually November 13 to 15, 2020. 

Researchers assessed long-term outcomes of iStent Inject plus phacoemulsification vs phacoemulsification alone in patients who participated in the pivotal iStent Inject randomized controlled trial (ClinicalTrials.gov identifier NCT00323284). All trial participants were invited to take part in an additional 36-month visit. In total, 136 iStent Inject participants and 40 phacoemulsification participants agreed to the extended follow-up. 

At 36-months postoperative, mean IOP in med-free eyes was 15.9 ± 2.75 mm Hg in the iStent Inject group compared with 16.7 ± 2.58 mm Hg in the phacoemulsification group (n=98 and 34, respectively). Patients in the iStent Inject group experienced a significantly greater reduction in med-free IOP vs baseline (-8.0 ± 3.2 mm Hg) compared with patients in the phacoemulsification group (-6.2 ± 2.31 mm Hg; P =.011). More eyes in the iStent Inject group also experienced clinically meaningful 36-month med-free IOP reductions compared with baseline: 47.1% vs 27.5% with a ≥30% reduction (P =.028) compared with 64.7% vs 47.5% with ≥20% reduction in the phacoemulsification group (P =.05). 

“Sustained 36-month IOP and med reductions were achieved with iStent Inject plus [phacoemulsification],” the researchers concluded, “with clinically and statistically greater IOP reduction versus placebo alone.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures. 

Reference

Samuelson TW. Three-year pivotal trial outcomes of iStent Inject Trabecular Micro-Bypass + phacoemulsification vs phaco alone in POAG. Presented at: American Academy of Ophthalmology 2020 Annual Meeting; November 13-15, 2020. Abstract PO185.