Prospective randomised study evaluating one, two, or three trabecular micro-bypass stents for OAG: 5-year outcomes

Session Details

Session Title: Microinvasive Glaucoma Surgery

Session Date/Time: Sunday 15/09/2019 | 14:00-16:00

Paper Time: 14:06

Venue: Free Paper Forum: Podium 4

First Author: : A.Carceller Guillamet SPAIN

Co Author(s): :                                 

Abstract Details

Purpose:

To assess intraocular pressure (IOP) decrease, medication burden reduction, and safety of 1, 2, or 3 trabecular micro-bypass stents (iStent®) implanted in eyes with open-angle glaucoma (OAG) on topical glaucoma medications.

Setting:

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

Methods:

Subjects with OAG on 1 to 3 ocular hypotensive medications were enrolled in this prospective, randomized study. Preoperative IOP was required to be 18-30 mmHg on medication and 22-38 mmHg following medication washout. Subjects were randomized (1:1:1) to undergo trabecular micro-bypass surgery with 1, 2 or 3 trabecular micro-bypass stents as a standalone procedure. Medication washout was performed annually. Postoperative ocular hypotensive medications were to be started in cases of elevated IOP and/or optic nerve change. The study assessed IOP, medication use, best-corrected visual acuity (BCVA), slit-lamp examination, gonioscopy findings, fundus/optic nerve evaluation, complications and adverse events.

Results:

Subjects were randomized to 1 stent (n=38), 2 stents (n=41), and 3 stents (n=40). Preoperatively, mean medicated IOP ranged from 19.8-20.4 mmHg and post-washout IOP was 25.0-25.1 mmHg in the three groups. Through 5 years postoperative, mean medicated IOP was ≤18 mmHg in all 3 groups. Medication was needed in significantly more single-stent eyes (22 of 38 initial eyes) than eyes with 2 or 3 stents (9 of 41 initial eyes, and 6 of 40 initial eyes, respectively). Favorable safety included no intra- or perioperative complications, and stable C:D ratio through 5 years.

Conclusions:

Outcomes through 5 years following standalone single or multiple iStent implantation(s) demonstrated safe, clinically meaningful IOP and medication reduction in eyes with OAG, with incrementally greater benefits in eyes receiving multiple stents. More eyes in the multiple stent groups remained medication-free compared to the single-stent group. These findings add to existing clinical evidence for iStent devices as an effective, durable and safe treatment modality for OAG.

Financial Disclosure:

research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented