NCT06139523Recruiting
Optimize Pediatric OCT Imaging
Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 24 Jan 2024
- Primary completion date
- Jul 2027
- Lead sponsor
- Duke University
- Diseases
- Glaucoma
- NCT number
- NCT06139523
What you commit to
- Study type: Observational
- Planned participants: 30
- From 24 Jan 2024 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with prior problems with pupil dilation
- Pregnant woman if receiving dilating drops
Other illness
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
Other
- 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
Who the study is looking for
- 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
Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Eye Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.