Advancing Pediatric Retinal Imaging With Auto-aligned OCT

This study is testing a new version of a handheld device called Auto-aligned OCT. This device helps doctors take pictures of the retina (the light-sensitive tissue at the back of your eye) more easily and clearly, especially in children. The goal is to improve how we detect and monitor eye conditions like retinal disease and glaucoma. Researchers will look at how many participants have abnormal retinal microanatomy (tiny structures in the retina), the severity of these abnormalities, and retinal thickness. The study is currently unclear on its recruitment status. You may be able to join if you are a healthy adult, an adult patient with an eye condition, or a child with an eye condition, aged 1 month or older.

Study design
This is an interventional study planning to enroll 50 participants, including healthy adults, adult patients, and pediatric patients.
What's involved
You would participate in up to 4 single imaging sessions at clinical visits over 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years, based on the imaging sessions.

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NCT06841575

Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Recruiting
NAAges 1+Interventional
Duke University
~50 participants
Updated 2026-03-25 on ClinicalTrials.gov
What's tested:Auto-aligned OCT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with abnormal retinal microanatomy
Measured over Up to 4 single imaging sessions at clinical visits over 2 years
+2 more outcomes measured
Eye Diseases
Retinal Disease
Glaucoma
Optic Nerve Diseases
1 sites across 1 states
North Carolina1
  • Xi Chen, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University

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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
Group 2: Adult patients in ophthalmology clinics
Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
Subject is able and willing to consent to study participation
Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
Group 3: Pediatric participants in ophthalmology clinics
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: Adult patients in ophthalmology clinics
Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
Group 3: Pediatric participants in ophthalmology clinics
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)
  • Number of participants with abnormal retinal microanatomyUp to 4 single imaging sessions at clinical visits over 2 years

    Measured by optical coherence tomography (OCT) reading.

  • Severity of abnormal retinal microanatomyUp to 4 single imaging sessions at clinical visits over 2 years

    Measured by optical coherence tomography (OCT) reading.

  • Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysisUp to 4 single imaging sessions at clinical visits over 2 years

    Measured by optical coherence tomography (OCT) analysis.