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The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP) | Clinical Trials | Clareo Health

COMPLETEDNA

The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)

Minimally Invasive Micro Sclerostomy System - Long- Term Follow-Up Extension Study

NCT07051174•Sanoculis Ltd

View on ClinicalTrials.gov

Summary

No new investigational device is used in this study. This study is an extension follow up study conducted in continuation of the prior MIMS® study (see: STUDY ID: MMS EEU-1), in which the long-term (i.e., 28, 36, 42 months) clinical outcomes of Minimally Invasive Micro Sclerostomy System \[MIMS® System\] \[CE Marked device\] are evaluated.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female ≥ 18 years to ≤ 85 years old
•Subject who underwent either standalone MIMS® surgery or MIMS® surgery in combination with phacoemulsification, in continuation of the previous clinical investigation with the MIMS® device (see: STUDY ID: MMS EEU-1), and surgery was performed not earlier than 2 years from enrollment
•Subject who is considered complete success (i.e., 20% or greater reduction in IOP from Baseline on no medications) and qualified success (i.e., 20% or greater reduction in IOP from Baseline on the same or less number of medications) or failure with IOP \>21mmHg with no medications at 1 year post MIMS® surgery (see: STUDY ID: MMS EEU-1)
•Subject who is able and willing to attend all scheduled assessments
•Subject understands and signs the informed consent

Exclusion Criteria

•Subject who was considered failure at 1 year after the MIMS® surgery
•Any subject with major protocol deviation from the prior MIMS® study (ID: MMS EEU-1)
•Other secondary glaucoma (such as neovascular, uveitic, lens-induced, trauma-induced, or glaucoma associated with increased episcleral venous pressure) in the study eye, since the MIMS® surgery in the study eye
•Any ocular disease in the study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements
•Any ocular surgery since the MIMS® surgery in the study eye
•Severe trauma in the study eye since the MIMS® surgery in the study eye
•Current participation or participation in another investigational drug or device clinical trial within the last 30 days before enrollment in the study
•Pregnant or lactating women

Locations (1)

Malayan

Yerevan, Armenia

Key Dates

Start Date

April 11, 2022

Primary Completion Date

August 30, 2023

Completion Date

October 27, 2023

Last Updated

July 4, 2025

Enrollment

ACTUAL participants

Conditions

Glaucoma

Interventions

MIMS

DIAGNOSTIC_TEST

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT04354545

GlaucomaOcular Surface Disease

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RECRUITINGNA

Automated Applanation Tonometry - Updated

NCT07298356

GlaucomaGlaucoma, Suspect

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP): The Minimally Invasive Micro Sclerostomy (MIMS®) System is Intended for the Reduction of Elevated Intraocular Pressure (IOP)

Inclusion Criteria

Exclusion Criteria

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

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