Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Recruiting
N/A
Interventional Study
Primary Open Angle Glaucoma
Open Angle Glaucoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 129 (estimated)
- Sponsor
- Sanoculis Ltd · Industry
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About This Trial
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 f…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female, ≥ 40 years to ≤ 85 years old
2. Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
3. Primary open angle glaucoma diagnosis based on:
1. Visual field mean deviation of -3dB or…
Contacts