Name

561 - Réduction pressionnelle après implantation du stent trabéculaire de seconde génération iStent inject® : résultats à 48 mois

To prospectively evaluate implantation of 2 second-generation trabecular micro-bypass stents (iStent inject®) as a standalone procedure in patients with OAG not controlled by 1 ocular hypotensive medication.

This prospective, single-arm study enrolled subjects with OAG not controlled on 1 ocular hypotensive medication, and with preoperative IOP of 18-30 mmHg (medicated) and 22-28 mmHg (post- washout).  All subjects underwent implantation of 2 iStent inject stents as a standalone procedure.  Medication washout was performed annually.  Assessments through 48 months included IOP, medication burden, adverse events, BCVA, and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations. Postoperative safety and efficacy evaluation through 5 years is ongoing.

All subjects (n=57) underwent standalone iStent inject implantation and completed 48 months of follow-up.  Preoperatively, mean medicated IOP was 19.5±1.5 mmHg and post-washout IOP was 24.4±1.3 mmHg.  Postoperatively, mean IOP was ≤14.6 mmHg at all visits through M48; and M48 mean IOP was 13.2 mmHg (32% and 46% reduced vs. preoperative medicated and unmedicated IOP’s, respectively).  At M48, 95% of subjects achieved both medication-free IOP ≤18 mmHg and IOP reduction ≥20% vs. preoperative unmedicated IOP.  Favorable safety included no intraoperative or device-related AEs, BCVA of 20/40 or better in 93% of eyes, and stable C:D ratio and VF MD.

In OAG eyes with IOP not controlled on 1 medication, standalone iStent inject implantation resulted in sustained 48-month IOP and medication reductions, together with favorable safety, including stable optic nerve and visual fields.

These findings of iStent inject implanted as a standalone procedure show significant beneficial outcomes.