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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Feasibility Clinical Evaluation of the Calibreye System
