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To prospectively evaluate long-term performance of 2nd generation trabecular micro-bypass stents (iStent inject®) implanted as a standalone procedure in patients with open-angle glaucoma (OAG) not controlled by 1 ocular hypotensive medication.
This 5-year controlled, prospective, single-arm study enrolled subjects with OAG and preoperative intraocular pressure (IOP) of 18-30 mmHg on 1 medication (med) and 22-28 mmHg after washout. All subjects underwent implantation of iStent inject stents as a standalone procedure. Assessments through Month 60 (M60) included IOP, med burden, adverse events (AEs), best-corrected visual acuity (BCVA), visual fields (VF), cup-to-disc ratio (C:D), and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations.
All 57 subjects underwent successful standalone iStent inject implantation and completed M60 follow-up. Preoperatively, mean IOP on a single med was 19.5±1.5 mmHg and unmedicated (post-washout) IOP was 24.4±1.3 mmHg. At all visits through M60, mean IOP was ≤14.6 mmHg. At M60, mean IOP was 12.9 mmHg (34% and 47% reduction vs preoperative medicated and unmedicated IOPs, respectively; p<0.0001 for both). At M60, of med-free eyes, 91% achieved unmedicated IOP ≤18 mmHg and 91% had IOP reduction ≥20% vs preoperative washout IOP. All but 4 eyes were med-free at M60. Favorable safety included no intraoperative or device-related AEs, BCVA 20/40 or better in 93% of eyes, and stable C:D and VF.
In OAG eyes with IOP not controlled on 1 med, standalone iStent inject implantation resulted in significant, sustained, and safe IOP and med reductions through 5 years postop with most eyes med-free. This favorable benefit-to-risk profile of standalone iStent inject implantation adds to existing evidence of the device’s safety and efficacy.
This presentation is from the session "SPS-105 Minimally Invasive Glaucoma Surgery: Viscocanalostomy, Combined Procedures, Outcomes" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.