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Optimize Pediatric OCT Imaging
NCT06139523 · Duke University
In plain English
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Official title
Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study
About this study
Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.
The investigators plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography).
Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory.
Eligibility criteria
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)
Study design
Enrollment target: 30 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2024-01-24
Estimated completion: 2026-12
Last updated: 2025-09-17
Interventions
Device: Investigational contact OCT systemDevice: Investigational noncontact OCT system:
Primary outcomes
- • Presence of abnormal retinal microanatomy as measured by OCT reading (Single imaging session (day 1))
- • Severity of abnormal retinal microanatomy as measured by OCT reading (Single imaging session (day 1))
- • Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis (Single imaging session (day 1))
Sponsor
Duke University · other
Contacts & investigators
ContactXi Chen, MD · contact · xi2.chen@duke.edu · (919)684-8434
ContactMichelle N McCall, MCAPM, BA · contact · michelle.mccall@duke.edu · (919) 684-0544
All locations (1)
Duke University Eye CenterRecruiting
Durham, North Carolina, United States