Feasibility Clinical Evaluation of the Calibreye System

NCT ID: NCT05885022

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma, Open-Angle

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Device Arm

Subjects will receive a Calibreye glaucoma device (permanent implant)

Group Type EXPERIMENTAL

Calibreye System

Intervention Type DEVICE

Implantation of a glaucoma device to reduce intraocular pressure

Interventions

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Calibreye System

Implantation of a glaucoma device to reduce intraocular pressure

Intervention Type DEVICE

Other Intervention Names

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Glaucoma device, Glaucoma implant, Aqueous Shunt

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Myra Vision Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith Barton, MD

Role: STUDY_CHAIR

Moorfields Eye Hospital NHS Foundation Trust

Locations

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Dr. Agarwal's Eye Hospital Ltd.

Chennai, , India

Site Status ACTIVE_NOT_RECRUITING

Centro Oftalmologico de Chihuahua

Chihuahua City, , Mexico

Site Status RECRUITING

Oftalmología Láser de Puebla S.C.

Puebla City, , Mexico

Site Status RECRUITING

Panama Eye Center

Panama City, , Panama

Site Status RECRUITING

Countries

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India Mexico Panama

Central Contacts

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Shienal Patel

Role: CONTACT

14085602500

Michelle Tran

Role: CONTACT

14085602500

Facility Contacts

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Mayra Salinas

Role: primary

52 61 4364 7898

Aimee Hernandez

Role: primary

(22) 2257-0970

Idabel Orillac

Role: primary

+507 269 7475

Other Identifiers

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CFP-101, CFP-103

Identifier Type: -

Identifier Source: org_study_id

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