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Feasibility Clinical Evaluation of the Calibreye System

Sponsor
Myra Vision Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05885022
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
22
Anticipated Duration (Months)
10
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Calibreye System
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility Clinical Evaluation of the Calibreye System
Actual Study Start Date :
May 31, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Apr 1, 2025

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure [12 Months]

      Percent change in IOP from baseline to the 12-month visit

    2. Adverse Events [12 Months]

      Number and percentage of subjects having any adverse event

    Secondary Outcome Measures

    1. Glaucoma Medication Usage [12 Months]

      Change in number of medications used compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lions Eye Diabet Clinic Tbilisi Georgia 0177
    2 Dr. Agarwal's Eye Hospital Ltd. Chennai India 600018
    3 Oftalmología Láser de Puebla S.C. Puebla Mexico 72540

    Sponsors and Collaborators

    • Myra Vision Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myra Vision Inc.
    ClinicalTrials.gov Identifier:
    NCT05885022
    Other Study ID Numbers:
    • CFP-101, CFP-102, CFP-103
    First Posted:
    Jun 1, 2023
    Last Update Posted:
    Jun 6, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Glaucoma, Open-Angle

    Study Results

    No Results Posted as of Jun 6, 2023