RecruitingNot ApplicableNCT06841575
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Sponsor
Duke University
Enrollment
50 participants
Start Date
Mar 23, 2026
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 1 Month
Inclusion Criteria12
- 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 Criteria9
- 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)
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Interventions
DEVICEAuto-aligned OCT
Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06841575
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