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

Not Applicable

Recruiting

• Conditions: Primary Open Angle Glaucoma; Open Angle Glaucoma
• Interventions: Device: Minimally Invasive Micro Sclerostomy Device

• Registration Number: NCT06313749
• Lead Sponsor: Sanoculis Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-02
• Study First Submitted QC: 2024-03-09
• Study First Posted: 2024-03-15
• Study Start: 2024-06-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 129

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIMS® Device/Procedure Arm	Minimally Invasive Micro Sclerostomy Device	Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.

Primary Outcome Measures

Name	Time	Method
Surgical success rate of the MIMS® device/procedure at 12 months after surgery	12 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

Secondary Outcome Measures

Name	Time	Method
Safety Outcome 3	12 months	Preservation of Best-Corrected Visual Acuity (BCVA)
Exploratory Effectiveness Endpoint 2	12 months	Change in IOP (% change) from baseline to 12 months follow-up
Exploratory Effectiveness Endpoint 3	12 months	Change in the number of IOP lowering topical medications from screening to 12 months follow-up
Exploratory Effectiveness Endpoint 1	12 months	Change in IOP (mmHg) from baseline to 12 months follow-up
Safety Outcome 2	12 months	Biomicroscopic slit lamp and ophthalmoscopy findings
Safety Outcome 1	12 months	Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period
Exploratory Effectiveness Endpoint 4	12 months	Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up

Trial Locations

Locations (1)

Glaucoma Associates of Texas; 🇺🇸 Dallas, Texas, United States