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

January 8, 2025 updated by: Sanoculis Ltd
This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • S. Malayan Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of subjects of Armenian descent that underwent the MINT procedure.

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years to ≤ 85 years old
  2. Subject who underwent MINT, and surgery was performed not earlier than 18 months from enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MINT Surgery Cohort
Cohort that includes subjects that have undergone the MINT surgical procedure.
Device: Minimally Invasive Micro Trabeculostomy
The MINT system is a surgical device designed to create a trabeculostomy within the eye.
Other Names:
  • MINT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular Pressure Measurement
Time Frame: 18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).
Observed IOP at long-term timepoints
18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Outcomes
Time Frame: 0-24 +/-2 months post MINT surgery from previous study (MMS-EEU-4).
Incidence of adverse events related to MINT device/procedure, including visual acuity and postoperative complications, throughout the study follow-up.
0-24 +/-2 months post MINT surgery from previous study (MMS-EEU-4).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanoculis Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2022

Primary Completion (Actual)

October 22, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMS-EEU-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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