Calibreye System: Implantation of a glaucoma device to reduce intraocular pressure
Study summary
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Intraocular Pressure — 12 Months Percent change in IOP from baseline to the 12-month visit
Adverse Events — 12 Months Number and percentage of subjects having any adverse event
Trial sites (4)
Facility
City
Region
Status
Dr. Agarwal's Eye Hospital Ltd.
Chennai
India
Active Not Recruiting
Centro Oftalmologico de Chihuahua
Chihuahua City
Mexico
Recruiting
Oftalmología Láser de Puebla S.C.
Puebla City
Mexico
Recruiting
Panama Eye Center
Panama City
Panama
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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