Performance and Safety of Minimally Invasive Nasal Trabeculostomy (MINT™) in Open-Angle Glaucoma: A 12-month Open-Label Study on Patients with No Other Glaucoma Surgeries

Lilit Voskanyan,1,2 Hovsep Miroyan,1 Vahan Papoyan,1 Haik Babayan,1 Davinder S Grover3 1Ophtholmology Department Ophthalmological Center After S.V. Malayan, Yerevan, Armenia; 2Ophthalmology Department Mikhitar Heratsi Yerevan State Medical University, Yerevan, Armenia; 3Glaucoma Associates of Texas, Dallas, TX, USACorrespondence: Lilit Voskanyan, Ophthalmological Center After S.V. Malayan, Fučiki Street, 30 Buildings (District: Avenue), Yerevan, Armenia, Tel +374 10 344944, Email [email protected] Davinder S Grover, Glaucoma Associates of Texas, 10740 N Central Expy Ste 300, Dallas, TX, 75231, USA, Tel +1 214 360-0000, Fax +1 214 739-8562, Email [email protected]: Minimally invasive nasal trabeculostomy (MINT™) is an ab interno, stent-less, trabecular-opening glaucoma procedure designed to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). 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.Methods: Eligible patients had uncontrolled OAG (IOP ≥ 21 mmHg with maximum tolerated glaucoma medications). 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 number or fewer medications at Week 52.Results: The procedures were performed between 11 April 2022 and 24 October 2022 by one surgeon (LV) at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Sixty-six eyes of 66 patients underwent the procedure; 63 and 56 patients completed the Week 24 and 52 visits, respectively. Fifty-two of 63 (82.5%) patients achieved the primary endpoint. The mean (standard deviation) baseline IOP (22.7 ± 1.4 mmHg) was reduced by 34.2% to 15.0 ± 2.8 mmHg at Week 24, and by 35.3% to 14.7 ± 2.4 mmHg at Week 52. Twenty-two adverse events (AEs) were reported, including 20 postoperative ocular AEs in 15 patients. Ocular AEs were non-serious and mild.Conclusion: In this patient population, the MINT device achieved an 82.5% success rate as per the FDA-recommended primary endpoint. IOP was lowered from baseline, below the European Glaucoma Society target range for early glaucoma (< 20 mmHg) in 98.4% of patients and moderate glaucoma (< 17 mmHg) in 68.3% of patients. No intraoperative and minimal postoperative complications were reported.Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05638906 (NCT05638906).Keywords: ab interno, glaucoma filtration surgery, IOP-lowering medication, minimally invasive nasal trabeculostomy, open-angle glaucoma