ClinicalTrials.gg
RecruitingNCT05885022Updated Dec 15, 2025

Feasibility Clinical Evaluation of the Calibreye System

An interventional study of Calibreye System in Glaucoma, Open-Angle, sponsored by Myra Vision Inc.. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Myra Vision Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Glaucoma, Open-Angle

Browse trials for

03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

This is the only study on the registry with Myra Vision Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Investigational Device Arm

    Subjects will receive a Calibreye glaucoma device (permanent implant)

    Device: Calibreye System

Interventions

  • DeviceCalibreye System

    Implantation of a glaucoma device to reduce intraocular pressure

    Also known as: Glaucoma device, Glaucoma implant, Aqueous Shunt

06

What researchers measure

Primary outcomes

  1. Intraocular Pressure

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

    Time frame: 12 Months

  2. Adverse Events

    Number and percentage of subjects having any adverse event

    Time frame: 12 Months

Secondary outcomes

  1. Glaucoma Medication Usage

    Change in number of medications used compared to baseline

    Time frame: 12 Months

07

Study locations

3 of 4 sites recruiting
  • Dr. Agarwal's Eye Hospital Ltd.
    Chennai, 600018, India
    Active, not recruiting

    Not enrolling at this site.

  • Centro Oftalmologico de Chihuahua
    Chihuahua City, Mexico
    Recruiting
    • Mayra Salinas · Contactmayra_dj@hotmail.com · 52 61 4364 7898
    • Ana Cristina Luna, MD · Principal investigator
  • Oftalmología Láser de Puebla S.C.
    Puebla City, 72540, Mexico
    Recruiting
    • Aimee Hernandez · Contactaimeehdz20@gmail.com · (22) 2257-0970
    • Gabriel Salomón Lazcano Gómez, MD · Principal investigator
  • Panama Eye Center
    Panama City, Panama
    Recruiting
    • Idabel Orillac · Contactidabelo28@gmail.com · +507 269 7475
    • Lautaro Vera, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Dec 2027, 55 months after the start.

Of 70 industry-sponsored interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 55 months is above that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2023
First posted
Jun 1, 2023
StartActual
May 31, 2023
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2028
Last update
Dec 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05885022
Lead sponsor
Myra Vision Inc.
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
May 31, 2023
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Dec 15, 2025

Study contacts

Shienal Patel
Contact
info@myravision.com
14085602500
Michelle Tran
Contact
info@myravision.com
14085602500
Keith Barton, MD
study chair · Moorfields Eye Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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