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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06612346
Enrollment
36
Registered
2024-09-25
Start date
2022-11-04
Completion date
2024-12-31
Last updated
2025-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma

Keywords

MINT, Trabeculostomy, Minimally Invasive Glaucoma Surgery, MIGS, Intraocular Pressure

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.

Interventions

DEVICEMinimally Invasive Micro Trabeculostomy

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

Sponsors

Sanoculis Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraocular Pressure Measurement18 months +/- 2 months post-MINT surgery from previous study (MMS-EEU-4).Observed IOP at long-term timepoints

Other

MeasureTime frameDescription
Adverse Events Outcomes0-24 +/-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.

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026