Feasibility Clinical Evaluation of the Calibreye System

August 17, 2023 updated by: Myra Vision Inc.
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Barbara Niksch
  • Phone Number: 19495336101

Study Locations

  • India
      • Chennai, India, 600018
        • Recruiting
        • Dr. Agarwal's Eye Hospital Ltd.
        • Contact:
        • Principal Investigator:
          • Ashvin Agarwal, MD
  • Mexico
      • Puebla, Mexico, 72540
        • Recruiting
        • Oftalmología Láser de Puebla S.C.
        • Contact:
        • Principal Investigator:
          • Gabriel Salomón Lazcano Gómez, MD
  • Panama
      • Panama City, Panama
        • Recruiting
        • Panama Eye Center
        • Contact:
        • Principal Investigator:
          • Ernesto Calvo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational Device Arm
Subjects will receive a Calibreye glaucoma device (permanent implant)
Device: Calibreye System
Implantation of a glaucoma device to reduce intraocular pressure
Other Names:
  • Glaucoma device, Glaucoma implant, Aqueous Shunt

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myra Vision Inc.

Investigators

  • Study Chair: Keith Barton, MD, Moorfields Eye Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFP-101, CFP-102, CFP-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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