New eye implant aims to ease glaucoma pressure without daily drops
NCT ID NCT05885022
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called the Calibreye System, a small implant placed in the eye to help drain fluid and lower pressure in people with open-angle glaucoma. Researchers will check if it is safe and works well over 12 months in 60 adults. The goal is to see if the device can reduce eye pressure and possibly cut down on the number of glaucoma medications needed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Calibreye System (glaucoma implant device)
- What this could lead to
- If successful, this device could offer a new way to lower eye pressure and reduce the need for daily eye drops in people with open-angle glaucoma.
- What could go wrong
- This is an early feasibility study with only 60 people, so results may not apply to everyone. The device may not lower pressure enough or could cause side effects like infection or implant failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Centro Oftalmologico de Chihuahua
RECRUITINGChihuahua City, Mexico
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Dr. Agarwal's Eye Hospital Ltd.
ACTIVE_NOT_RECRUITINGChennai, 600018, India
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Oftalmología Láser de Puebla S.C.
RECRUITINGPuebla City, 72540, Mexico
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Panama Eye Center
RECRUITINGPanama City, Panama
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Other studies related to the condition(s) this trial covers.
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- Can a bangkok community eye check reveal hidden glaucoma risks?
- Can a laser treat glaucoma without touching the eye?
- Micro-Coil stent aims to drain glaucoma pressure during cataract surgery
- Eye implant could replace daily drops for glaucoma