Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Recruiting now · Not applicable
Conditions studied: Primary Open Angle Glaucoma, Open Angle Glaucoma
In brief
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.
Key facts
- Study ID
- NCT06313749
- Run by
- Sanoculis Ltd
- People needed
- 129
- Starts
- 2024-06-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-08-07
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Glaucoma Associates of Texas — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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