NCT07081347

This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.

Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sanoculis Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study. It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or less medications in the prior MMS EEU-7 study, will be available for assessment in this study. The data from these patients will be included in the IOP performance and medication use analysis. In addition to these subjects, data from subjects defined as failure in the prior investigations with MINT® (see: STUDY ID: MMS EEU-4; STUDY ID: MMS EEU-7) will be included in the overall success analysis (i.e., Kaplan Mayer survival analysis). Based on recommendations of the EGS expert discussion group (European Glaucoma Society (EGS), 2023), the IOP levels of 2-3 mmHg and 20%-30% medication free patients have been proposed as the minimal clinically important difference (MCID) for surgical interventions for glaucoma. In this study, by 3 years post MINT® surgery, a sample size of 20 patients is expected to be adequate to demonstrate a reduction of at least -6 mmHg with 95% confidence interval (CI) lower limit of at least -4.6 mmHg which is higher than the MCID required; and at least 45% of free-medication patients with 95%CI lower limit of 21.8% which is in line with the minimum MCID recommendations.

Conditions

• Glaucoma
• Ocular Hypertension
• Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	MINT Minimally Invasive Nasal Trabeculostomy	The MINT® system is a powered surgical device for ab-interno nasal trabeculostomy. It creates \~100-micron trabeculostomy openings from the anterior chamber into Schlemm's canal by removing trabecular meshwork (TM) segments. The system includes a sterile stainless-steel Surgical Device with a micro trephine, driven by a motorized Activation Device that controls rotation and movement. The procedure facilitates aqueous outflow to lower IOP, with minimal collateral tissue damage.

Timeline

• Start date: 2025-06-16
• Primary completion: 2025-06-30
• Completion: 2025-07-21
• First posted: 2025-07-23
• Last updated: 2025-07-28

Locations

1 site across 1 country: Armenia