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

Open Angle Glaucoma Clinical Trial

Official title:

An Observer-Masked, Single-Arm, Multicenter Study to Evaluate the Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313749
• Other study ID #: MMS-US-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Sanoculis Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 129
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma
• Primary Open Angle Glaucoma

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanoculis Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Achieved 20% or more reduction in average diurnal IOP from baseline at 12 months after surgery; AND; Using the same number or fewer topical IOP lowering medications	12 months
Secondary	Exploratory Effectiveness Endpoint 1	Change in IOP (mmHg) from baseline to 12 months follow-up	12 months
Secondary	Exploratory Effectiveness Endpoint 2	Change in IOP (% change) from baseline to 12 months follow-up	12 months
Secondary	Exploratory Effectiveness Endpoint 3	Change in the number of IOP lowering topical medications from screening to 12 months follow-up	12 months
Secondary	Exploratory Effectiveness Endpoint 4	Change in number (% change) of IOP lowering topical medications from screening to 12 months follow-up	12 months
Secondary	Safety Outcome 1	Incidence of ocular adverse events in the study eye (overall and related to MIMS® device/procedure) throughout the follow-up period	12 months
Secondary	Safety Outcome 2	Biomicroscopic slit lamp and ophthalmoscopy findings	12 months
Secondary	Safety Outcome 3	Preservation of Best-Corrected Visual Acuity (BCVA)	12 months