RecruitingNot ApplicableNCT05885022
Feasibility Clinical Evaluation of the Calibreye System
Sponsor
Myra Vision Inc.
Enrollment
60 participants
Start Date
May 31, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria7
- 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
Interventions
DEVICECalibreye System
Implantation of a glaucoma device to reduce intraocular pressure
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05885022
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