NCT06614218
Not yet recruiting
Not Applicable
Minimally Invasive Micro Sclerostomy (MIMS®) Retrospective Chart Review
ConditionsOpen Angle Glaucoma
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sanoculis Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in IOP from medicated baseline at 12 months post-MIMS® surgery
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eye treated with MIMS® Device as a standalone procedure
- •MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in IOP from medicated baseline at 12 months post-MIMS® surgery
Time Frame: 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
Time Frame: Medicated baseline at 12 months post-MIMS® surgery
Success rate at 12 months post-MIMS® surgery
Time Frame: 12 months post-MIMS® surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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