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NCT Number: NCT05885022

Feasibility Clinical Evaluation of the Calibreye System

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

Recruiting

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Agarwal's Eye Hospital Ltd., Chennai, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calibreye System

Device

Implantation of a glaucoma device to reduce intraocular pressure

Other names: Glaucoma device, Glaucoma implant, Aqueous Shunt

Primary outcomes

  1. Intraocular Pressure

    Time frame: 12 Months

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

  2. Adverse Events

    Time frame: 12 Months

    Number and percentage of subjects having any adverse event

Secondary outcomes

  1. Glaucoma Medication Usage

    Time frame: 12 Months

    Change in number of medications used compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Tran

CONTACT

[email protected]

14085602500

Shienal Patel

CONTACT

[email protected]

14085602500

Sponsors and collaborators

Lead sponsor

Myra Vision Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 1, 2023
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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