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

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: Minimally Invasive Micro Trabeculostomy

• Registration Number: NCT06612346
• Lead Sponsor: Sanoculis Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-25
• Primary Completion: 2024-10-22
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MINT Surgery Cohort	Minimally Invasive Micro Trabeculostomy	Cohort that includes subjects that have undergone the MINT surgical procedure.

Primary Outcome Measures

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

Trial Locations

Locations (1)

S. Malayan Eye Center; 🇦🇲 Yerevan, Armenia