MIMS® Retrospective Chart Review

Not yet recruiting

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

• Registration Number: NCT06614218
• Lead Sponsor: Sanoculis Ltd

Brief Summary

This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Eye treated with MIMS® Device as a standalone procedure
2. MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MIMS Surgery Cohort	Minimally Invasive Micro Sclerostomy	This cohort consists subjects treated with MIMS® Device as a standalone procedure during time period (27 Sep 2023 - 31 May 2025), and with documented post-operative follow-up available in the medical charts.

Primary Outcome Measures

Name	Time	Method
Change in IOP from medicated baseline at 12 months post-MIMS® surgery	Medicated baseline at 12 months post-MIMS® surgery
Change in the number of topical IOP-lowering medications from medicated baseline at 12 months post-MIMS® surgery	Medicated baseline at 12 months post-MIMS® surgery
Success rate at 12 months post-MIMS® surgery	12 months post-MIMS® surgery

Trial Locations

Locations (1)

S. Malayan Eye Center; 🇦🇲 Yerevan, Armenia