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

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Primary Open Angle Glaucoma; Open Angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIMS® Device/Procedure Arm

Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.

Group Type: EXPERIMENTAL

Minimally Invasive Micro Sclerostomy Device

Intervention Type: 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.

Interventions

Minimally 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.

Intervention Type: DEVICE

Other Intervention Names

MIMS® Device

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanoculis Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glaucoma Associates of Texas

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Khan Lau, OD

Role: CONTACT

khan@sanoculis.com

8082862666

Facility Contacts

Davinder Grover, MD

Role: primary

dgrover@glaucomaassociates.com

Other Identifiers

MMS-US-1

Identifier Type: -

Identifier Source: org_study_id