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NCT06313749 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
A NA study of Open Angle Glaucoma and Primary Open Angle Glaucoma, sponsored by Sanoculis.
- Recruiting
- Registry status
- NA
- Development phase
- 129
- Enrollment target
- 1
- Study location
NCT06313749 is a NA study of Open Angle Glaucoma and Primary Open Angle Glaucoma that is actively recruiting participants, run by Sanoculis. The registered enrollment target is 129 participants, below the 330-participant average among 28 other Open Angle Glaucoma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06313749, a NA study of Open Angle Glaucoma and Primary Open Angle Glaucoma, is actively recruiting participants, sponsored by Sanoculis.
- RECRUITING
- Registry status
- NA
- Development phase
- 129 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Minimally Invasive Micro Sclerostomy Device
Study Locations (1)
Texas
- Glaucoma Associates of Texas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06313749
The ClinicalTrials.gov registry entry for NCT06313749 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 330-participant average among 28 other Open Angle Glaucoma trials with a reported enrollment target (61% lower). The listed sponsor is Sanoculis, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Open Angle Glaucoma appearing as the primary indexed condition, and to 1 intervention - of which Minimally Invasive Micro Sclerostomy Device is the first listed.
NCT06313749 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06313749 about?
NCT06313749 is a clinical study titled "Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy". 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 p...
What is the current status of trial NCT06313749?
This trial is currently recruiting. It is a NA study. The enrollment target is 129 participants. The study started on 2024-06-01. Estimated completion is 2025-12.
What conditions does trial NCT06313749 study?
This clinical trial studies the following conditions: Open Angle Glaucoma, Primary Open Angle Glaucoma.
What interventions are being tested in trial NCT06313749?
The interventions under investigation include: Minimally Invasive Micro Sclerostomy Device (DEVICE).
Who is sponsoring clinical trial NCT06313749?
This trial is sponsored by Sanoculis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06313749 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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