Feasibility Clinical Evaluation of the Calibreye System

Last updated: December 9, 2024
Sponsor: Myra Vision Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Calibreye System

Clinical Study ID

NCT05885022
CFP-101, CFP-103
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Angle closure glaucoma

  • Congenital, neovascular or other secondary glaucomas

  • Previous intraocular surgery (with the exception of laser trabeculoplasty oruncomplicated phacoemulsification with IOL occurring > 3 months prior to thepreoperative visit)

  • Previous glaucoma shunt/valve in the target quadrant

  • Clinically significant inflammation or infection in the study eye within 30 daysprior to the preoperative visit

  • History of corneal surgery, corneal opacities or corneal disease

  • Active diabetic retinopathy

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Calibreye System
Phase:
Study Start date:
May 31, 2023
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Lions Eye Diabet Clinic

    Tbilisi, 0177
    Georgia

    Site Not Available

  • Dr. Agarwal's Eye Hospital Ltd.

    Chennai, 600018
    India

    Site Not Available

  • Centro Oftalmologico de Chihuahua

    Chihuahua,
    Mexico

    Active - Recruiting

  • Oftalmología Láser de Puebla S.C.

    Puebla, 72540
    Mexico

    Active - Recruiting

  • Panama Eye Center

    Panama City,
    Panama

    Active - Recruiting

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