MIGS with 2 second generation trabecular bypass stents in eyes with primary open-angle glaucoma on 1 preoperative medication: outcomes through 2 years

Session Details

Session Title: Glaucoma

Session Date/Time: Monday 09/10/2017 | 08:00-10:30

Paper Time: 09:54

Venue: Room 4.1

First Author: : K.Schargel SPAIN

Co Author(s): :    J. Belda Sanchis   J. Ruiz Colecha   J. Campello              

Abstract Details

Purpose:

To evaluate long-term outcomes of micro-invasive glaucoma surgery (MIGS) with 2 second-generation trabecular micro-bypass stents (iStent inject, Glaukos) in a sole procedure without concomitant cataract surgery in patients with primary open-angle glaucoma (POAG) on 1 preoperative ocular hypotensive medication. The iStent inject stents are inserted in Schlemm’s canal via ab interno implantation and can reestablish physiologic outflow and reduce intraocular pressure (IOP) via creation of a direct access to Schlemm's canal.

Setting:

Hospital Universitario de Torrevieja, Alicante. Spain S.V. Malayan Opthalmology Centre, Yerevan, Armenia

Methods:

This 5-year, prospective, nonrandomized, unmasked, single-arm study enrolled 57 qualified phakic subjects with POAG on 1 ocular hypotensive medication prior to surgery with preoperative medicated IOP of 18-30 mmHg and unmedicated (post-washout) IOP of 22-38 mmHg. Eligible subjects were implanted with 2 second-generation trabecular micro-bypass stents in a sole procedure. Efficacy and safety evaluations include IOP, best-corrected visual acuity (BCVA), topical ocular hypotensive medication use, adverse events, and findings from slit-lamp, gonioscopy, fundus/optic nerve, visual fields and pachymetry assessments. All subjects have been followed through 24 months; longer follow-up is continuing

Results:

Mean postoperative IOP was about 14 mmHg over the 24 month follow-up (representing ~43% reduction in IOP from the mean preoperative unmedicated IOP of 24.4 mmHg). All but one subject (98%) achieved IOP ≤18 mmHg without medication at M24 as well as unmedicated IOP reduction ≥20% vs. preoperative unmedicated IOP. All subjects remained hypotensive medication-free with the exception of one who was placed on a medication at M18 (due to change in optic nerve appearance). One subject experienced BCVA reduction due to advancing of pre-existing cataract, but otherwise all subjects underwent uncomplicated implantation of stents and postoperative safety was excellent.

Conclusions:

Two year follow-up of this study provides evidence for safe sustained IOP and medication reduction in eyes with POAG on 1 preoperative glaucoma medication after standalone implantation of two second-generation trabecular micro-bypass stents (iStent inject). This microsurgical technique may constitute a desirable alternative for patients with earlier stages of OAG. The results confirm that IOP reduction to ≤15 mmHg with elimination of medication can safely be achieved after implantation of 2 iStent inject devices in POAG eyes with IOP not managed to below 18 mmHg on 1 preoperative medication. A favorable safety profile is also demonstrated.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented