Actively Recruiting
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Led by Sanoculis Ltd · Updated on 2024-08-07
129
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 40 to 85 years old
- Inadequately controlled primary open angle glaucoma with screening mean diurnal intraocular pressure of 21 mmHg to 40 mmHg despite multiple medications
- Diagnosis of primary open angle glaucoma based on visual field mean deviation of -3dB or worse
- Glaucomatous optic nerve damage confirmed by optic disc or retinal nerve fiber layer abnormalities
- Presence of healthy, free, and mobile conjunctiva in the target quadrant
- Prior ab interno conjunctival-sparing glaucoma procedures done more than 6 months before enrollment
- Ability and willingness to attend all scheduled follow-up exams
- Understanding and signing of informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
K
Khan Lau, OD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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