RecruitingNot ApplicableNCT06313749

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

An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy


Sponsor

Sanoculis Ltd

Enrollment

129 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive surgical procedure called MIMS (Minimally Invasive Micro Sclerostomy) for lowering eye pressure in patients with open-angle glaucoma that remains uncontrolled despite using multiple eye drops. The device creates a tiny drainage channel in the eye to allow fluid to escape and reduce pressure. **You may be eligible if...** - You are between 40 and 85 years old - You have open-angle glaucoma with elevated eye pressure (21–40 mmHg) even while using multiple prescription eye drops - Your glaucoma has caused measurable visual field loss and structural damage to the optic nerve - The white part of your eye (conjunctiva) in the target area is healthy and free of scarring - Any previous minimally invasive glaucoma procedures were done more than 6 months ago **You may NOT be eligible if...** - Your eye pressure is above 40 mmHg or is controlled on medications - You have scarring or damage to the conjunctiva in the target area - You have had a prior surgery that would prevent the MIMS procedure (such as a trabeculectomy or tube shunt) - You have active eye inflammation or other eye conditions that could affect results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMinimally Invasive Micro Sclerostomy Device

During this clinical trial, the Minimally Invasive Micro Sclerostomy (MIMS®) procedure will be performed by investigators using the proprietary MIMS® device developed by Sanoculis Ltd.


Locations(1)

Glaucoma Associates of Texas

Dallas, Texas, United States

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NCT06313749


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