Advancing Pediatric Retinal Imaging With Auto-aligned OCT (NCT06841575) | Clinical Trial Compass
RecruitingNot Applicable
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
United States50 participantsStarted 2026-03-23
Plain-language summary
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Who can participate
Age range1 Month
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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 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: 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 t…
What they're measuring
1
Number of participants with abnormal retinal microanatomy
Timeframe: Up to 4 single imaging sessions at clinical visits over 2 years
2
Severity of abnormal retinal microanatomy
Timeframe: Up to 4 single imaging sessions at clinical visits over 2 years
3
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
Timeframe: Up to 4 single imaging sessions at clinical visits over 2 years