An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Sanoculis Ltd
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.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
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 worse and 2. Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos 4. Presence of healthy, free, and mobile conjunctiva in the target quadrant 5. Prior ab interno conj…
Interventions
- DeviceMinimally Invasive Micro Sclerostomy Device
During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.
Location
- Glaucoma Associates of TexasDallas, Texas