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)

NCT07051174 | Completed

• 1 other identifier: MMS EEU-3
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:

  • IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.

  28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

Secondary Outcomes (1)

• • IOP Levels at the following time points:

  28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

Study Arms (1)

Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up)

EXPERIMENTAL

This follow-up extension study is aimed to monitor the long-term IOP-lowering performance/efficacy and safety of the MIMS® procedure in open angle glaucoma eyes.

Diagnostic Test: MIMS

Interventions

MIMS DIAGNOSTIC_TEST

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.

Intervention Arm: MIMS® Minimally Invasive Trabeculostomy in OAG Patients (36-Month Follow-Up)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanoculis Ltd: lead

Study Sites (1)

Malayan

Yerevan, Armenia

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 4, 2025
• Study Start: April 11, 2022
• Primary Completion: August 30, 2023
• Study Completion: October 27, 2023
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

AR (1)