Feasibility Clinical Evaluation of the Calibreye System

Launched by MYRA VISION INC. · May 22, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Feasibility Clinical Evaluation of the Calibreye System" is looking into a new device called the Calibreye System, designed for patients with open-angle glaucoma. The main goal of this study is to see how safe and practical this device is for helping manage eye pressure in individuals with this condition. If you or a loved one is between the ages of 65 and 74 and has open-angle glaucoma with certain characteristics, you might be eligible to participate.

To qualify for this trial, participants must have specific types of glaucoma, a certain level of eye pressure (between 18 and 45 mmHg), and a particular score on a vision test that indicates their condition is serious enough. However, individuals with other types of glaucoma, significant eye infections, or certain previous eye surgeries might not be eligible. Participants can expect to be closely monitored throughout the trial to assess the safety and effectiveness of the Calibreye System. This study is currently recruiting, so if you think you or someone you know might be interested, it could be a great opportunity to contribute to advancing treatment options for glaucoma.

Gender

ALL

Eligibility criteria

• 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