Performance And Safety Of Minimally Invasive Nasal Trabeculostomy (Mint®) In Open-Angle Glaucoma: A 24-Month Open-Label Study
Published 2025 - 43rd Congress of the ESCRS
Reference: PO643 | Type: Free paper | DOI: 10.82333/qbfx-pc16
Authors: Uri Elbaz* 1 , Li-Tal Pratt 2 , Iliya Simantov 3 , Issac Levy 1 , Azzam Ghaben 4 , Romi Noy Achiron 5
1Department of Ophthalmology ,Rabin Medical Center, Petah Tikva, and Faculty of Medicine Tel Aviv University,Petah Tikva,Israel, 2Department of Radiology,Tel Aviv Sourasky Medical Center and Faculty of Medicine, Tel Aviv University,Tel Aviv ,Israel, 3Department of Ophthalmology ,Rabin Medical Center and Faculty of Medicine Tel Aviv University,Petah Tikva,Israel, 4Department of Radiology Neuro-radiology unit,Rabin Medical Center, Petah Tikva, and Faculty of Medicine Tel Aviv University,Petah Tikva,Israel, 5department of Radiology,Tel Aviv Sourasky Medical Center and Faculty of Medicine, Tel Aviv University,Tel Aviv ,Israel
Purpose
Minimally Invasive Nasal Trabeculostomy (MINT®) is an ab interno, stent-less glaucoma drainage procedure that is designed to reduce intraocular pressure (IOP) in patients with mild to moderate open-angle glaucoma (OAG). The motorized device creates one or more trabeculostomy openings of ~140μm diameter each, directly from the anterior chamber into Schlemm’s canal, by removing segments of the trabecular meshwork (TM), thus facilitating aqueous outflow with minimal damage to the surrounding tissues. This 2 Years, prospective, single-arm, open-label study aimed to evaluate the performance and safety of the MINT® device in patients with mild to moderate OAG and uncontrolled IOP (NCT05638906).
Setting
The MINT® procedure was performed on 66 eyes of 66 patients by one surgeon at the Ophthalmologic Center at the S.V. Malayan Eye Center in Yerevan, Armenia. The procedures were conducted between 11 April 2022 and 24 October 2022.
Methods
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 2 Years. The primary efficacy endpoint was the proportion of patients achieving ≥20% IOP reduction from baseline on the same or fewer medications. Secondary efficacy endpoints were mean change in IOP and number of anti-glaucoma medications from baseline.
Results
Sixty-six eyes of 66 patients underwent the MINT® procedure; 56 and 36 patients completed the 1 and 2-years visits, respectively. Fifty-two of 56 (92.9%) patients achieved ≥20% IOP reduction from baseline on the same or fewer number of medications at Year 1, and 35/36 (97.2%) at Year 2. The mean SD baseline IOP of 22.7±1.4 mmHg was reduced by 35.2% to 14.7±2.4 mmHg at Year 1, and by 35.9% to 14.6±2.2 mmHg at Year 2. A total of 31 AEs were reported, including 29 post-operative ocular AEs in 22 patients (33.3%). All ocular AEs were non-serious and mild. No intraoperative complications were reported.
Conclusions
In this patient population, the MINT® device effectively lowered average IOP from baseline at 1 and 2 tears, below the European Glaucoma Society target range for early (<20 mmHg) and moderate (<17 mmHg) glaucoma. The success rates at 1 and 2 years were satisfactory. No intra-operative and minimal post-operative complications were reported, possibly owing to the minimally invasive nature and short duration of the procedure.