Feasibility Clinical Evaluation of the Calibreye System

Myra Vision

Status: Enrolling

Conditions: Glaucoma, Open-Angle

Treatments: Device: Calibreye System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05885022

CFP-101, CFP-103

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Investigational Device Arm

Experimental group

Description:

Subjects will receive a Calibreye glaucoma device (permanent implant)

Treatment:

Device: Calibreye System