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Optimizing Pediatric OCT Imaging for Retinal Diseases

This study is comparing two new handheld OCT (Optical Coherence Tomography) systems to see how well they can image the eyes of children. OCT is a special camera that takes detailed pictures of the back of the eye, which is very helpful for conditions like retinal disease, glaucoma, and optic nerve diseases. The study is testing a new contact system called Theia imaging and an investigational noncontact system developed at Duke University. Researchers want to see if Theia imaging can capture a wider area of the retina while still providing clear images. They will look for abnormal retinal microanatomy (tiny structures in the retina), how severe it is, and the thickness of the retina. This study plans to include 30 participants, including healthy adults and children. The current recruitment status is unclear.

Study design
This is an observational study comparing two investigational OCT systems, planning to enroll 30 participants.
What's involved
You would participate in a single imaging session on one day. This involves having your eyes imaged with the OCT systems.
Compensation
Not stated in the trial record.
Follow-up
Your retinal microanatomy and thickness will be measured during a single imaging session, with no further follow-up specified.

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NCT06139523

Optimize Pediatric OCT Imaging

Recruiting
Not specifiedAll AgesObservational
Duke University
~30 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Investigational contact OCT systemInvestigational noncontact OCT system:

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of abnormal retinal microanatomy as measured by OCT reading
Measured over Single imaging session (day 1)
+2 more outcomes measured

Conditions

Retinal Disease
Glaucoma
Optic Nerve Diseases

Explore related trials

GlaucomaOptic Nerve DisorderRetinal Disorder

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

Xi Chen, MD
[email protected]
(919)684-8434
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Presence of abnormal retinal microanatomy as measured by OCT readingSingle imaging session (day 1)
  • Severity of abnormal retinal microanatomy as measured by OCT readingSingle imaging session (day 1)
  • Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysisSingle imaging session (day 1)

    Retinal thickness (microns) at the fovea and surrounding optic nerve.