Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

Recruiting

• Conditions: Open Angle Glaucoma
• Interventions: Device: Inferonasal Minimally Invasive Micro Sclerostomy

• Registration Number: NCT06577857
• Lead Sponsor: Sanoculis Ltd

Brief Summary

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Inferonasal MIMS Surgery Cohort	Inferonasal Minimally Invasive Micro Sclerostomy	Cohort that includes subjects that have undergone the MIMS® inferonasal surgery.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure Change (Baseline to 24 months)	Baseline to 24 months post-MIMS® surgery	Change in IOP from medicated baseline to 24 months post-MIMS® surgery
Intraocular Pressure Change (Baseline to 30 months)	Baseline to 30 months post-MIMS® surgery	Change in IOP from medicated baseline to 30 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months)	Medicated baseline to 24 months post-MIMS® surgery	Change in the number of topical IOP-lowering medications from medicated baseline to 24 months post-MIMS® surgery
Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months)	Medicated baseline to 30 months post-MIMS® surgery	Change in the number of topical IOP-lowering medications from medicated baseline to 30 months post-MIMS® surgery
Surgery Success Rate (24 months)	24 months post-MIMS® surgery	Success rate 24 months post-MIMS® surgery
Surgery Success Rate (30 months)	30 months post-MIMS® surgery	Success rate 30 months post-MIMS® surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative Complication Safety Outcomes	Baseline to 30 months post-MIMS® surgery	Late (greater than 12 months) postoperative complications
Interventional Safety Outcomes	Baseline to 30 months post-MIMS® surgery	Late (greater than 12 months) postoperative interventions

Trial Locations

Locations (1)

S. Malayan Eye Center; 🇦🇲 Yerevan, Armenia