Feasibility Clinical Evaluation of the Calibreye System

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05885022

Enrollment

Registered

2023-06-01

Start date

2023-05-31

Completion date

2028-12-31

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

Brief summary

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

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

DEVICECalibreye System

Implantation of a glaucoma device to reduce intraocular pressure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

India, Mexico, Panama

Contacts

Primary ContactShienal Patel

info@myravision.com14085602500

Backup ContactMichelle Tran