Clinical Trial

Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

Recruiting
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Record status
This record was last updated August 7, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to show non-inferiority of the MIMS® device/procedure with Mitomycin-C, in terms of its surgical success rate, compared to trabeculectomy with Mitomycin-C in subjects diagnosed with primary open angle glaucoma, whose intraocular pressure is not controlled despite polypharmacy. Eligible screened participants will undergo the MIMS® procedure and will be followed for a period of 12 months in this single-arm study. Investigators will compare the results of this study to the surgical success rate of traditional trabeculectomy with Mitomycin-C.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-03-09.
Status change: Not Yet Recruiting → Recruiting 2024-08-06
Trial Details
NCT Number NCT06313749
Lead Sponsor Sanoculis Ltd
Conditions Primary Open Angle Glaucoma, Open Angle Glaucoma
Enrollment 129 participants
Start Date 2024-06-01
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-07