NCT05885022

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
May 2023Dec 2028

First Submitted

Initial submission to the registry

May 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

4.5 years

First QC Date

May 22, 2023

Last Update Submit

December 8, 2025

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

  • Intraocular Pressure

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

    12 Months

  • Adverse Events

    Number and percentage of subjects having any adverse event

    12 Months

Secondary Outcomes (1)

  • Glaucoma Medication Usage

    12 Months

Study Arms (1)

Investigational Device Arm

EXPERIMENTAL

Subjects will receive a Calibreye glaucoma device (permanent implant)

Device: Calibreye System

Interventions

Calibreye SystemDEVICE

Implantation of a glaucoma device to reduce intraocular pressure

Also known as: Glaucoma device, Glaucoma implant, Aqueous Shunt
Investigational Device Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr. Agarwal's Eye Hospital Ltd.

Chennai, 600018, India

ACTIVE NOT RECRUITING

Centro Oftalmologico de Chihuahua

Chihuahua City, Mexico

RECRUITING

Oftalmología Láser de Puebla S.C.

Puebla City, 72540, Mexico

RECRUITING

Panama Eye Center

Panama City, Panama

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Glaucoma Drainage Implants

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Keith Barton, MD

    Moorfields Eye Hospital NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Shienal Patel

CONTACT

14085602500info@myravision.com

Michelle Tran

CONTACT

14085602500info@myravision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)ME(2)IN(1)