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Compares two eye imaging devices in children with eye disease

Compares two scanning devices for imaging the retina in children with eye conditions.

Plain-language title generated from the registry record
Registry title: Optimize Pediatric OCT Imaging

Key facts

Where
Durham, United StatesSee the site

Where in United States

  • Duke University Eye CenterDurham, United StatesTaking people

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Trial details

Who runs it
Duke University
Trial code
NCT06139523
Record updated
5 August 2026
Original 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 Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.Read full original descriptionShow less

Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot 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 hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

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: Subjects with prior problems with pupil dilation; Pregnant woman if receiving dilating drops; Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract); Group 1 - Healthy adult volunteers; Students or employees under direct supervision of the investigators; Group 2 - Pediatric participants; Parent/legal guardian unwilling or unable to provide consent.

ClinicalTrials.gov NCT06139523