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)

Not Applicable

Completed

• Conditions: Glaucoma

• Registration Number: NCT07051174
• Lead Sponsor: Sanoculis Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Primary Completion: 2023-08-30
• Study Completion: 2023-10-27
• Study First Submitted: 2025-05-28
• Status Verified: 2025-06
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Observed IOP at Long- Term ( >2 Years) post-MIMS® surgery:	28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery	• IOP will be measured for subjects who have completed the MIMS® surgery and no earlier than 2 years from the procedure.

Secondary Outcome Measures

Name	Time	Method
• 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	IOP will be measured for subjects who have completed the MIMS® surgery and assessed at least one of the following visits (the data from more than one visit will be also collected): 28 +/-3 months post-MIMS® surgery 36 +/-3 months post-MIMS® surgery 42 +/-3 months post-MIMS® surgery

Trial Locations

Locations (1)

Malayan; 🇦🇲 Yerevan, Armenia