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A European study of the efficacy and safety of a supraciliary glaucoma drainage device in patients with open-angle glaucoma

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First Author: J.Garcia-Feijoo SPAIN

Co Author(s):    N. Pfeiffer   P. Denis   C. Hirneiß   F. Aptel           

Abstract Details

Purpose:

To describe the safety and efficacy profile of a novel, supraciliary, micro-invasive glaucoma surgery (MIGS) drainage system, MINIject (iSTAR Medical, Wavre, Belgium), in European patients with medically-uncontrolled open-angle glaucoma. ClinicalTrials.gov: NCT03624361

Setting:

The trial was carried out as a prospective, multi-centre, interventional, single-arm study (STAR-II) in 8 sites across 3 countries in Europe.

Methods:

A 5mm-long supraciliary device was successfully implanted in 29 eyes in a stand-alone, ab-interno procedure. The device is made of biocompatible STAR® material which is soft and flexible silicone in a micro-porous network design. Intraocular pressure (IOP), medication use, and other ocular parameters are evaluated preoperatively and postoperatively at pre-specified timepoints up to 24-month follow-up. The primary endpoint is the success rate 6 months after surgery, greater than 60%. Success is defined as diurnal IOP ≤ 21mmHg and > 5mmHg with a minimum 20% reduction from baseline, with or without the concomitant use of glaucoma hypotensive medication.

Results:

Baseline mean diurnal IOP was 24.6±3.8mmHg using 2.9±1.2 IOP-lowering medications. At 6-month follow-up, 75.9% of patients reached success, meeting the primary endpoint. Mean diurnal IOP was reduced by 9.9mmHg (40.2%) from baseline to 14.7mmHg (p<0.0001), and medication was 1.0±1.3. Furthermore, 79.3% of patients had mean IOP≤18mmHg, 82.8% achieved ≥20% IOP-reduction from baseline and 55.2% were medication-free. Six SAEs associated with medical events and related to the device were reported in the study eye, including eye pain (1), corneal erosion (1), chorioretinal folds (1), and IOP increase (3), all resolved. There were no cases of hypotony.

Conclusions:

This supraciliary MIGS device implanted in a standalone procedure was shown to be a powerful treatment option 6 months post-implantation to reduce IOP and decrease the need for medication in patients with open-angle glaucoma. Long-term results up to 24 months are awaited.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by 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