Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Recruiting · NCT06313749 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanoculis Ltd
View the official record on ClinicalTrials.gov →Interventions studied
Minimally Invasive Micro Sclerostomy Device
What this trial is about
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.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female, ≥ 40 years to ≤ 85 years old
- Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
- Primary open angle glaucoma diagnosis based on:
- Visual field mean deviation of -3dB or worse and
- 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
- Presence of healthy, free, and mobile conjunctiva in the target quadrant
- Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\])
- Subject is able and willing to attend all scheduled follow-up exams
- Subject understands and signs the informed consent
Where it is running
1 location listed across 1 US state.
- Glaucoma Associates of Texas - Dallas, Texas, United States