Feasibility Clinical Evaluation of the Calibreye System | NCT05885022

Studies
Feasibility Clinical Evaluation of the Calibreye System

NCT05885022

Sponsor

Myra Vision Inc.

Status

Recruiting

Last Update Posted

Dec 15, 2025Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Glaucoma, Open-Angle

Interventions

Calibreye System

Countries

India
Mexico
Panama

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2023Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 22, 2023

First Submission Date that Met QC Criteria

May 22, 2023

First Posted Date

Jun 1, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2025

Last Update Posted Date

Dec 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Device Arm	Experimental	Subjects will receive a Calibreye glaucoma device (permanent implant)	Device: Calibreye System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Calibreye System	Device	Implantation of a glaucoma device to reduce intraocular pressure	Investigational Device Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shienal Patel	Contact	14085602500		info@myravision.com
Michelle Tran	Contact	14085602500		info@myravision.com

Overall Officials

Name	Affiliation	Role
Keith Barton, MD	Moorfields Eye Hospital NHS Foundation Trust	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Agarwal's Eye Hospital Ltd.	Active, not recruiting	Chennai		600018	India

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020327	Glaucoma Drainage Implants

Ancestor Terms

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided