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

NCT06313749 | Recruiting FDA Device

• 1 other identifier: MMS-US-1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Keywords

Open Angle Glaucoma; Polypharmacy; Intraocular Pressure; MIMS; Minimally Invasive Glaucoma Surgery; MIGS; MTMT

Outcome Measures

Primary Outcomes (1)

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

  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

  12 months

Secondary Outcomes (7)

• Exploratory Effectiveness Endpoint 1

  12 months

• Exploratory Effectiveness Endpoint 2

  12 months

• Exploratory Effectiveness Endpoint 3

  12 months

• Exploratory Effectiveness Endpoint 4

  12 months

• Safety Outcome 1

  12 months

Study Arms (1)

MIMS® Device/Procedure Arm

EXPERIMENTAL

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

Device: Minimally Invasive Micro Sclerostomy Device

Interventions

Minimally Invasive Micro Sclerostomy Device 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.

Also known as: MIMS® Device

MIMS® Device/Procedure Arm

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Primary open angle glaucoma diagnosis based on:
• Visual field mean deviation of -3dB or worse and
• 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
• Presence of healthy, free, and mobile conjunctiva in the target quadrant
• Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy \[GATT\])
• Subject is able and willing to attend all scheduled follow-up exams
• Subject understands and signs the informed consent

Sponsors & Collaborators

• Sanoculis Ltd: lead

Study Sites (1)

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Central Study Contacts

Khan Lau, OD

CONTACT

8082862666; khan@sanoculis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This clinical study is observer masked only when measuring intraocular pressure (using Goldmann Applanation Tonometry). Intraocular pressure measurements will be determined using the 2-person method to reduce bias. Observer 1 (masked to real time reading) will look through the slit lamp and turn the Goldmann Tonometer dial, and Observer 2 will read and record the intraocular pressure readings. Observer 1 will be unable to see the readings with the use of a masking card.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 15, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

US (1)