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

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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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

S. Malayan Eye Center

Yerevan, Armenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Minimally Invasive Micro Trabeculostomy

Device

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

Other names: MINT

Primary outcomes

Intraocular Pressure Measurement

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

Observed IOP at long-term timepoints

Other outcomes

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.

Sponsors and collaborators

Lead sponsor

Sanoculis Ltd

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 25, 2024
Registry last updated: Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed