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

NCT ID: NCT06612346

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-04

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Open Angle Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MINT Surgery Cohort

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

Minimally Invasive Micro Trabeculostomy

Intervention Type DEVICE

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

Interventions

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Minimally Invasive Micro Trabeculostomy

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

Intervention Type DEVICE

Other Intervention Names

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MINT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanoculis Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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S. Malayan Eye Center

Yerevan, , Armenia

Site Status

Countries

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Armenia

Other Identifiers

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MMS-EEU-7

Identifier Type: -

Identifier Source: org_study_id

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