Feasibility Clinical Evaluation of the Calibreye System

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Investigational Device Arm
    • Subjects will receive a Calibreye glaucoma device (permanent implant)

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular Pressure
    • Time Frame: 12 Months
    • Percent change in IOP from baseline to the 12-month visit
  • Adverse Events
    • Time Frame: 12 Months
    • Number and percentage of subjects having any adverse event

Secondary Measures

  • Glaucoma Medication Usage
    • Time Frame: 12 Months
    • Change in number of medications used compared to baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Myra Vision Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Keith Barton, MD, Study Chair, Moorfields Eye Hospital NHS Foundation Trust
  • Overall Contact(s)
    • Robert Chang, 14085602500, info@myravision.com

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