To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Implantation of a glaucoma device to reduce intraocular pressure
Dr. Agarwal's Eye Hospital Ltd.
Chennai, India
ACTIVE_NOT_RECRUITINGCentro Oftalmologico de Chihuahua
Chihuahua City, Mexico
RECRUITINGOftalmología Láser de Puebla S.C.
Puebla City, Mexico
RECRUITINGIntraocular Pressure
Percent change in IOP from baseline to the 12-month visit
Time frame: 12 Months
Adverse Events
Number and percentage of subjects having any adverse event
Time frame: 12 Months
Glaucoma Medication Usage
Change in number of medications used compared to baseline
Time frame: 12 Months
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Panama Eye Center
Panama City, Panama
RECRUITING