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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: Recruiting NA study of Open Angle Glaucoma and Primary Open Angle Glaucoma, sponsored by Sanoculis.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06313749 shows while recruiting
NCT06313749 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 330-participant average among 28 other Open Angle Glaucoma trials with a reported enrollment target (61% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06313749's enrollment target sits among peer trials
129 16th of 28 higher than 13 of 28 other Open Angle Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Open Angle Glaucoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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