| NCT ID | NCT06139523 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Retinal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-01-24 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-01-24 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
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 * 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 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 - 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06139523 clinical trial?
This trial is open to participants of all sexes, studying Retinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06139523 currently recruiting?
Yes, NCT06139523 is actively recruiting participants. Contact the research team at xi2.chen@duke.edu for enrollment information.
Where is the NCT06139523 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT06139523 clinical trial?
NCT06139523 is sponsored by Duke University. The trial plans to enroll 30 participants.