Posters

Sustained 5-year safety and IOP outcomes in open-angle glaucoma subjects treated with trabecular micro-bypass stents (iStent inject)

Poster Details

First Author: F.Aptel FRANCE

Co Author(s):                        

Abstract Details

Purpose:

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.

Setting:

All surgeries and follow-up visits were completed at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

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.

Results:

All 57 subjects underwent successful standalone iStent inject implantation and completed M60 follow-up. Preoperatively, mean IOP on one medication was 19.5±1.5 mmHg and post-washout IOP was 24.4±1.3 mmHg. At all visits through M60, mean IOP was ≤15 mmHg off medication. At M60, mean medication-free IOP was 12.9 mmHg (47% reduction vs preoperative washout IOP; p<0.0001); 91% achieved medication-free IOP ≤18 mmHg and 91% had IOP reduction ≥20% vs preoperative washout IOP. All but 5 eyes were medication-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.

Conclusions:

In OAG eyes with IOP not controlled on 1 medication, standalone iStent inject implantation resulted in significant, sustained, safe IOP and medication reductions through 5 years postoperative with most eyes off medication. This favorable benefit-to-risk profile of standalone iStent inject implantation adds to existing evidence of the device’s safety and efficacy.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a competing company