Status:
RECRUITING
Optimize Pediatric OCT Imaging
Lead Sponsor:
Duke University
Conditions:
Retinal Disease
Glaucoma
Eligibility:
All Genders
Brief Summary
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 I...
Detailed Description
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 I...
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)
Key Trial Info
Start Date :
January 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06139523
Start Date
January 24 2024
End Date
December 1 2026
Last Update
September 17 2025
Active Locations (1)
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1
Duke University Eye Center
Durham, North Carolina, United States, 27710