Outcomes through 60 months following standalone implantation of two trabecular micro-bypass stents in eyes with OAG not controlled on one medication

Session Details

Session Title: Glaucoma & Posterior Segment

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 08:30

Venue: Room A3, Podium 1

First Author: : E.Donnenfeld USA

Co Author(s): :                        

Abstract Details

Purpose:

Trabecular micro-bypass stents have shown to safely reduce IOP in patients with glaucoma. This ongoing 5-year study evaluates long-term outcomes relating to safety and efficacy of two trabecular micro-bypass stents (iStent®) implanted as a standalone procedure in patients with open-angle glaucoma (OAG).

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 one ocular hypotensive medication. Qualified subjects were implanted with two iStent devices as a standalone procedure. Study eyes were phakic or pseudophakic with a C/D ratio of ≤0.9 and preoperative IOP of 18-30 mmHg (medicated) and 22-38 mmHg (after medication washout). Efficacy and safety evaluations included IOP, medication burden, slit-lamp, gonioscopy, funduscopy/ON evaluation, BCVA, and AEs. A previously published report showed favorable outcomes through three years.

Results:

Thirty-nine subjects enrolled underwent uncomplicated implantation. Thirty subjects have completed 60 months postoperative follow-up. Preoperative medicated IOP was 20.6 mmHg and post-washout IOP was 24.1. IOP reduction ≥20% from baseline and IOP ≤18 mmHg without medication were achieved by ~90% of subjects at M60. Postoperatively, mean IOP remained ≤15.2 mmHg for all visits through M60. 87% of subjects did not require additional glaucoma medication following implantation. No device-related AEs were observed. Six eyes experienced BCVA loss due to progression of pre-existing cataract, the most frequently reported AE. BCVA, C/D ratio and VFs were stable over the course of the study.

Conclusions:

The study showed that two iStents implanted as a standalone procedure to treat OAG subjects on a single preoperative medication provided significant, sustained, and safe reduction of IOP to less than or equal to 15 mmHg through 60 months postoperative. Long-term IOP reduction without postoperative medication burden after implantation of 2 iStents is an encouraging finding. Micro-invasive glaucoma surgery with iStent adds to the treatment option for patients with OAG.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented