NCT05885022RecruitingNot Applicable
Feasibility Clinical Evaluation of the Calibreye System
Myra Vision Inc.7 sites in 3 countries60 target enrollmentStarted: May 31, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 7
- Primary Endpoint
- Intraocular Pressure
Study Overview
Brief Summary
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Detailed Description
This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Open angle, pseudoexfoliative or pigmentary glaucoma
- •IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
- •Visual field mean deviation score of -3dB or worse
- •Area of healthy, free and mobile conjunctiva in the target quadrant
- •Shaffer angle grade ≥ 3 in the target quadrant
Exclusion Criteria
- •Angle closure glaucoma
- •Congenital, neovascular or other secondary glaucomas
- •Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring > 3 months prior to the preoperative visit)
- •Previous glaucoma shunt/valve in the target quadrant
- •Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
- •History of corneal surgery, corneal opacities or corneal disease
- •Active diabetic retinopathy
Outcomes
Primary Outcomes
Intraocular Pressure
Time Frame: 12 Months
Percent change in IOP from baseline to the 12-month visit
Adverse Events
Time Frame: 12 Months
Number and percentage of subjects having any adverse event
Secondary Outcomes
- Glaucoma Medication Usage(12 Months)
Investigators
Study Sites (7)
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