Sustained IOP and medication reduction after MIGS with second-generation trabecular bypass stents in OAG: 48-month outcomes

Session Details

Session Title: Presented Poster Session: Glaucoma I

Venue: Poster Village: Pod 3

First Author: : F.Aptel FRANCE

Co Author(s): :                           

Abstract Details

Purpose:

To prospectively evaluate implantation of iStent inject® (2nd generation trabecular micro-bypass stents) 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 prospective, single-arm study enrolled subjects with OAG not controlled on 1 ocular hypotensive medication, and with preoperative intraocular pressure (IOP) of 18-30 mmHg (medicated) and 22-28 mmHg (unmedicated 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, best-corrected visual acuity (BCVA), and findings from slit-lamp, gonioscopy, and fundus/optic nerve examinations. Postoperative safety and efficacy evaluation through 5 years is ongoing.

Results:

All subjects (n=57) underwent standalone iStent inject implantation and completed 48 months of follow-up.  Preoperatively, mean medicated IOP was 19.5±1.5mmHg and post-washout IOP was 24.4±1.3mmHg.  Postoperatively, mean IOP was < 15 mmHg at all visits through M48; M48 mean IOP was 13.2 mmHg (32% and 46% reduction vs. preoperative medicated and unmedicated IOPs).  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 cupdisc ratio and visual field mean deviation.

Conclusions:

In this cohort of OAG eyes with IOP not controlled on 1 medication, standalone iStent inject implantation resulted in sustained 48-month IOP and medication reductions. A high safety profile was observed including stable optic nerve and visual fields. These findings of iStent inject implanted as a standalone procedure show significant beneficial outcomes.

Financial Disclosure:

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