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NCT05885022 Clinical Trial

Feasibility Clinical Evaluation of the Calibreye System

Glaucoma, Open-Angle Clinical Trial

Official title:
Feasibility Clinical Evaluation of the Calibreye System

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05885022
Other study ID # CFP-101, CFP-102, CFP-103
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date April 2025

Study information
Verified date August 2023
Source Myra Vision Inc.
Contact Robert Chang
Phone 14085602500
Email info@myravision.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date April 2025
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Calibreye System
Implantation of a glaucoma device to reduce intraocular pressure

Locations
Country Name City State
India Dr. Agarwal's Eye Hospital Ltd. Chennai
Mexico Oftalmología Láser de Puebla S.C. Puebla
Panama Panama Eye Center Panama City

Sponsors (1)
Lead Sponsor Collaborator
Myra Vision Inc.

Countries where clinical trial is conducted

India,  Mexico,  Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular Pressure Percent change in IOP from baseline to the 12-month visit 12 Months
Primary Adverse Events Number and percentage of subjects having any adverse event 12 Months
Secondary Glaucoma Medication Usage Change in number of medications used compared to baseline 12 Months
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