NCT06612346

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

August 27, 2024

Last Update Submit

January 8, 2025

Conditions

Open Angle Glaucoma

Keywords

MINTTrabeculostomyMinimally Invasive Glaucoma SurgeryMIGSIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure Measurement

    Observed IOP at long-term timepoints

    18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).

Other Outcomes (1)

  • Adverse Events Outcomes

    0-24 +/-2 months post MINT surgery from previous study (MMS-EEU-4).

Study Arms (1)

MINT Surgery Cohort

Cohort that includes subjects that have undergone the MINT surgical procedure.

Device: Minimally Invasive Micro Trabeculostomy

Interventions

Minimally Invasive Micro TrabeculostomyDEVICE

The MINT system is a surgical device designed to create a trabeculostomy within the eye.

Also known as: MINT
MINT Surgery Cohort

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S. Malayan Eye Center

Yerevan, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2024

First Posted

September 25, 2024

Study Start

November 4, 2022

Primary Completion

October 22, 2024

Study Completion

December 31, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Locations

AR(1)