Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

Launched by SANOCULIS LTD · Mar 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called Minimally Invasive Micro Sclerostomy (MIMS®) to help lower eye pressure in patients with primary open-angle glaucoma who have not had success with multiple medications. The trial aims to show that MIMS® is at least as effective as a traditional surgery called trabeculectomy, both using a medication called Mitomycin-C to improve outcomes. Participants will undergo the MIMS® procedure and will be monitored for a year to see how well it works.

To be eligible for this trial, you need to be between 40 and 85 years old and have glaucoma that isn’t well controlled, with eye pressure readings higher than 21 mmHg. You should also have specific signs of glaucoma as confirmed by an eye doctor. Participants will be expected to attend follow-up appointments regularly to track their progress. If you’re interested, make sure you understand the study and can provide consent before enrolling.

Gender

ALL

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