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
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sanoculis Ltd
- Enrollment
- 129
- Locations
- 1
- Primary Endpoint
- Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
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.
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Surgical success rate of the MIMS® device/procedure at 12 months after surgery
Time Frame: 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 Outcomes
- Exploratory Effectiveness Endpoint 2(12 months)
- Exploratory Effectiveness Endpoint 3(12 months)
- Safety Outcome 3(12 months)
- Exploratory Effectiveness Endpoint 1(12 months)
- Safety Outcome 2(12 months)
- Safety Outcome 1(12 months)
- Exploratory Effectiveness Endpoint 4(12 months)