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New baby eye scanner could spot disease faster

NCT ID NCT06139523

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tests a new handheld eye scanner (Theia 1) against an existing one to see which takes better pictures of children's retinas. Researchers will scan 30 healthy adults and children to compare image quality and field of view. The goal is to improve diagnosis of eye diseases like glaucoma and retinal problems in infants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Theia 1 widefield imaging system (contact OCT device)
What this could lead to
If successful, this could lead to better, faster eye imaging for infants, helping doctors diagnose retinal diseases and glaucoma earlier.
What could go wrong
This is a small pilot study with only 30 participants, so results may not apply broadly. The new device might not work better than existing methods.

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.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Group 1 - Healthy adult volunteers (n=10). Participants over the age of 18 without known ocular issues other than refractive error. Group 2 - Pediatric participants (n=10). Participants under the age of 18 being seen at Duke Eye Center for ocular abnormailities.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Group 1 - Healthy adult volunteers * Subject is able and willing to consent to study participation * Subject is more than 18 years of age * Healthy adult volunteers without known ocular issues other than refractive error * Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential * Group 2 - Pediatric participants * Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian * Parent/legal guardian is able and willing to consent to study participation * Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center Exclusion Criteria: * Group 1 - Healthy adult volunteers * Students or employees under direct supervision of the investigators * Subjects with prior problems with pupil dilation * Pregnant woman if receiving dilating drops * Group 2 - Pediatric participants * Parent/legal guardian unwilling or unable to provide consent * Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

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Conditions

The condition(s) this trial relates to.

glaucoma optic nerve disorder retinal disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glaucoma Optic nerve diseases Retinal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Locations

  • Duke University Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

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