Glaucoma, Open-AngleNCT05885022
Feasibility Clinical Evaluation of the Calibreye System
A study testing Calibreye System in people with Glaucoma, Open-Angle, run by Myra Vision Inc. at 4 sites in 3 countries.
Trial summary
To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Calibreye System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 31 May 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Mexico2 sites, 2 recruiting
- Recruiting
Centro Oftalmologico de Chihuahua
Chihuahua City
Mayra Salinas, 52 61 4364 7898, mayra_dj@hotmail.com
Ana Cristina Luna, MD
- Recruiting
Oftalmología Láser de Puebla S.C.
Puebla City, 72540
Aimee Hernandez, (22) 2257-0970, aimeehdz20@gmail.com
Gabriel Salomón Lazcano Gómez, MD
India1 site
- Active, not recruiting
Dr. Agarwal's Eye Hospital Ltd.
Chennai, 600018
Panama1 site, 1 recruiting
- Recruiting
Panama Eye Center
Panama City
Idabel Orillac, +507 269 7475, idabelo28@gmail.com
Lautaro Vera, MD
About this study
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Calibreye System
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibreye SystemDevice
Also called Glaucoma device, Glaucoma implant, Aqueous Shunt
Implantation of a glaucoma device to reduce intraocular pressure
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device Arm | Experimental | Subjects will receive a Calibreye glaucoma device (permanent implant) Receives: Device: Calibreye System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
Percent change in IOP from baseline to the 12-month visit
Measured: 12 Months
Adverse Events
Number and percentage of subjects having any adverse event
Measured: 12 Months
Secondary outcomes (1)
Glaucoma Medication Usage
Change in number of medications used compared to baseline
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start31 May 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myra Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Barton, MD, Study chair, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885022
- Sponsor's protocol ID
- CFP-101, CFP-103
- Status last verified
- Dec 2025
- First submitted
- 22 May 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Evaluation of the Calibreye System
- ClinicalTrials.gov ID
- NCT05885022
- Acronym / sponsor ID
- CFP-101, CFP-103
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Myra Vision Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Device Arm | Experimental | Device: Calibreye SystemSubjects will receive a Calibreye glaucoma device (permanent implant) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calibreye SystemAlso: Glaucoma device, Glaucoma implant, Aqueous ShuntImplantation of a glaucoma device to reduce intraocular pressure | Device | Investigational Device Arm |
Primary outcome
Intraocular Pressure
Time frame: 12 Months
Percent change in IOP from baseline to the 12-month visit
Adverse Events
Time frame: 12 Months
Number and percentage of subjects having any adverse event
1 secondary outcome
Glaucoma Medication Usage
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keith Barton, MD study chair
Moorfields Eye Hospital NHS Foundation Trust
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibreye System in people with Glaucoma, Open-Angle, run by Myra Vision Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Mexico, India, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shienal Patel (14085602500, info@myravision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular Pressure (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.