Actively Recruiting
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS4) to Reduce Intraocular Pressure in Open-Angle Glaucoma Not Controlled Despite Multiple Medications
Led by Sanoculis Ltd · Updated on 2024-08-07
129
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Minimally Invasive Micro Sclerostomy (MIMS4) device and procedure to reduce intraocular pressure in people with primary open angle glaucoma that is not controlled despite multiple medications. The study aims to show that the MIMS4 procedure with Mitomycin-C is not less effective than traditional trabeculectomy with Mitomycin-C in controlling eye pressure. This is a single-arm, interventional clinical trial sponsored by Sanoculis Ltd.
CONDITIONS
Brief 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 aged 40 to 85 years
- Diagnosed with primary open angle glaucoma
- Intraocular pressure between 21 mmHg and 40 mmHg despite multiple glaucoma medications
- Visual field mean deviation of -3 dB or worse
- Evidence of glaucomatous optic nerve damage shown by structural abnormalities
- Presence of healthy, free, and mobile conjunctiva in the target eye area
- Prior conjunctival-sparing glaucoma procedures (e.g., iStent, Trabectome, GATT) done more than 6 months ago
- Able and willing to attend all scheduled follow-up exams
- Understands and signs 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo the Minimally Invasive Micro Sclerostomy (MIMS®) surgical procedure using the proprietary MIMS® device, followed by immediate post-operative care.
1 surgical visit (in-person)
Duration - 12 months
Participants return for follow-up visits to monitor safety and effectiveness of the MIMS® procedure over time.
Approximately 12 follow-up visits
Trial Site Locations
Total: 1 location
1
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
Actively Recruiting
Research Team
K
Khan Lau, OD
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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