Performance And Safety Of Minimally Invasive Nasal Trabeculostomy (Mint) In Open-Angle Glaucoma: A 12-Month Open-Label Study

Minimally invasive nasal trabeculostomy (MINT™) is an ab interno stent-less glaucoma filtration procedure that is designed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). The powered device creates trabeculostomy openings of ~100μm diameter each, directly from the anterior chamber into Schlemm’s canal, by removing segments of the trabecular meshwork (TM), thus increasing aqueous outflow with minimal damage to the surrounding tissues. This 12-month, prospective, single-arm, open-label study aimed to evaluate the performance and safety of the MINT™ device in patients with OAG with uncontrolled IOP (NCT05638906).

The MINT™ procedure was performed on 66 eyes of 66 patients by one surgeon at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. The procedures were conducted between 11 April 2022 and 24 October 2022.

Eligible patients underwent the MINT™ procedure if they had uncontrolled OAG (IOP ≥21 mmHg with tolerated glaucoma medications). IOP, glaucoma medications, best corrected visual acuity, complications/adverse events (AEs) and biomicroscopy were investigated at baseline and at all post-operative visits up to Week 24, with additional optional follow up to Week 52. The primary efficacy endpoint was the proportion of patients achieving ≥20% IOP reduction from baseline on the same or fewer medications at Week 24. Secondary efficacy endpoints were mean change in IOP from baseline at Weeks 24 and 52, and the proportion of patients achieving a ≥20% reduction in IOP from baseline on the same or less number of medications at Week 52.

Sixty-six eyes of 66 patients underwent the MINT™ procedure; 63 and 56 patients completed the 24 and 52 week visits, respectively. The mean SD procedure duration was 02:56±00:58 (min:sec). Fifty-two of 63 (82.5%) patients achieved ≥20% IOP reduction from baseline on the same or less number of medications at Week 24, and 52/56 (92.9%) at Week 52. The mean SD baseline IOP of 22.7±1.4 mmHg was reduced by 34.2% to 15.0±2.8 mmHg at Week 24, and by 35.2% to 14.7±2.4 mmHg at Week 52. A total of 22 AEs were reported, including 17 postoperative ocular AEs in 15 patients (22.7%). All ocular AEs were non-serious and mild. No intraoperative complications were reported.

In this patient population, the MINT™ device effectively lowered IOP from baseline, below the European Glaucoma Society target range for early (<20 mmHg) and moderate (<17 mmHg) glaucoma. No intra-operative and minimal post-operative complications were reported, possibly owing to the minimally invasive nature and short duration of the procedure.