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Procedure

MIMS Device for Glaucoma

N/A
Recruiting
Research Sponsored by Sanoculis Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the success rate of a new device/procedure called MIMS® with Mitomycin-C to the traditional trabeculectomy with Mitomycin-C in patients with primary

Who is the study for?
This trial is for men and women aged 40-85 with primary open-angle glaucoma, whose eye pressure isn't controlled despite using multiple medications. Participants must have a certain level of vision loss and be able to attend follow-up exams. They should not have had any recent eye surgeries that affect the conjunctiva.
What is being tested?
The study tests the MIMS® device/procedure against traditional trabeculectomy, both using Mitomycin-C, in reducing eye pressure for glaucoma patients over a period of 12 months. The goal is to show that MIMS® is at least as effective as the standard surgery.
What are the potential side effects?
While specific side effects are not listed here, minimally invasive procedures like MIMS® typically may cause less discomfort, redness or swelling compared to more extensive surgeries but can still include risks such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 85 years old.
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My glaucoma is not well-controlled, with eye pressure between 21 and 40 despite multiple medications.
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The targeted area of my eye's outer covering is healthy and moves freely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Secondary study objectives
Exploratory Effectiveness Endpoint 1
Exploratory Effectiveness Endpoint 2
Exploratory Effectiveness Endpoint 3
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MIMS® Device/Procedure ArmExperimental Treatment1 Intervention
Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.

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Who is running the clinical trial?

Sanoculis LtdLead Sponsor
8 Previous Clinical Trials
557 Total Patients Enrolled
~79 spots leftby Dec 2025
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