Feasibility Clinical Evaluation of the Calibreye System
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
India
Dr. Agarwal's Eye Hospital Ltd.
ACTIVE_NOT_RECRUITING
Chennai
Mexico
Centro Oftalmologico de Chihuahua
RECRUITING
Chihuahua City
Oftalmología Láser de Puebla S.C.
RECRUITING
Puebla City
Panama
Panama Eye Center
RECRUITING
Panama City
Contact Information
Primary
Shienal Patel
info@myravision.com
14085602500
Backup
Michelle Tran
info@myravision.com
14085602500
Time Frame
Start Date: 2023-05-31
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: Investigational Device Arm
Subjects will receive a Calibreye glaucoma device (permanent implant)
Related Therapeutic Areas
Sponsors
Leads: Myra Vision Inc.