Status:
RECRUITING
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Conditions:
Eye Diseases
Retinal Disease
Eligibility:
All Genders
1+ years
Phase:
NA
Brief 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 pa...
Detailed Description
Handheld OCT imaging is an advancement in ophthalmic imaging technology allowing us to image the pediatric retina. lt has tremendous potential to be applied to assess the structure and blood flow of c...
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
- 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 to provide consent
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
Key Trial Info
Start Date :
March 23 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06841575
Start Date
March 23 2026
End Date
September 1 2027
Last Update
March 25 2026
Active Locations (1)
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1
Duke University Eye Center
Durham, North Carolina, United States, 27710