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Purpose

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

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
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.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MIMS® Device/Procedure Arm 		Arm which includes subjects undergoing the MIMS® surgical procedure using the proprietary MIMS® device developed by Sanoculis Ltd.
  • 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.
    Other names:
    • MIMS® Device

Recruiting Locations

Glaucoma Associates of Texas
Dallas, Texas 75231
Contact:
Davinder Grover, MD
dgrover@glaucomaassociates.com

More Details

Status
Recruiting
Sponsor
Sanoculis Ltd

Study Contact

Khan Lau, OD
8082862666
khan@sanoculis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.