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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.

NCT07081347 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-07-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sanoculis Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2025-06-30
Completion
2025-07-21

Countries

  • Armenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081347 on ClinicalTrials.gov