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Clinical Trials in Mexico / NCT05885022
Recruiting Not applicable

Feasibility Clinical Evaluation of the Calibreye System

NCT05885022 · tracked via the Priya Life Science Mexico tracker
Sponsor
Myra Vision Inc
Phase
Not applicable
Started
2023-05-31
Last updated
2025-12-15

Condition(s) studied

Glaucoma, Open-Angle

Investigational drug(s) / intervention(s)

Calibreye System

Calibreye System: Implantation of a glaucoma device to reduce intraocular pressure

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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

Trial sites (4)

FacilityCityRegionStatus
Dr. Agarwal's Eye Hospital Ltd. Chennai India Active Not Recruiting
Centro Oftalmologico de Chihuahua Chihuahua City Mexico Recruiting
Oftalmología Láser de Puebla S.C. Puebla City Mexico Recruiting
Panama Eye Center Panama City Panama Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05885022 on ClinicalTrials.gov ↗ ← All trials in Mexico