Minimally Invasive Micro Sclerostomy (MIMS®) for Open-Angle Glaucoma

This study is testing a new procedure called Minimally Invasive Micro Sclerostomy (MIMS®) using a special device to lower eye pressure in people with open-angle glaucoma. This is for individuals whose eye pressure is not well-controlled even with multiple medications. The goal is to see if the MIMS® procedure is as successful at lowering eye pressure as a traditional surgery called trabeculectomy, both used with Mitomycin-C. You may be able to join if you are between 40 and 85 years old and have primary open-angle glaucoma with specific vision field changes and eye pressure between 21 and 40 mmHg. The study aims to measure the success rate of the MIMS® procedure 12 months after surgery. The current recruitment status is unclear.

Study design
This is a single-arm study planning to enroll 129 participants. It will compare the results of the MIMS® procedure to the known success rate of traditional trabeculectomy.
What's involved
Eligible participants will undergo the MIMS® procedure and will be followed for 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the surgery.

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NCT06313749

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

Recruiting
NAAges 40–85InterventionalTreatment
Sanoculis Ltd
~129 participants
Updated 2024-08-07 on ClinicalTrials.gov
What's tested:Minimally Invasive Micro Sclerostomy Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Measured over 12 months
Primary Open Angle Glaucoma
Open Angle Glaucoma
1 sites across 1 states
Texas1

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  • Surgical success rate of the MIMS® device/procedure at 12 months after surgery12 months

    Definition of Surgical Success: the subject's eye, after having the MIMS® procedure: 1. Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND 2. Using the same number or fewer topical IOP lowering medications