NCT06313749 Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
| NCT ID | NCT06313749 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanoculis Ltd |
| Condition | Primary Open Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 129 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 129 participants in total. It began in 2024-06-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\]) 6. Subject is able and willing to attend all scheduled follow-up exams 7. Subject understands and signs the informed consent
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06313749 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Primary Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06313749 currently recruiting?
Yes, NCT06313749 is actively recruiting participants. Contact the research team at khan@sanoculis.com for enrollment information.
Where is the NCT06313749 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06313749 clinical trial?
NCT06313749 is sponsored by Sanoculis Ltd. The trial plans to enroll 129 participants.