Auto-aligning handheld OCT for adult and pediatric retinal imaging
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
We will test a new handheld OCT device that automatically aligns to capture retinal images in healthy adults, adult eye patients, and children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 1 Month and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06841575 on ClinicalTrials.gov |
What this trial studies
This is a pilot observational imaging study of a new handheld OCT device that uses auto-alignment, online image-quality detection, and automatic saving to improve retinal image capture. The device will be used to acquire OCT and OCTA images in 20 healthy adult volunteers, 20 adult ophthalmology patients, and 10 pediatric patients seen at the Duke Eye Center. Imaging will occur in clinic settings or during clinically indicated examinations under anesthesia for pediatric patients when appropriate. The protocol builds on prior handheld OCT work and reports no known risks associated with the imaging procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are healthy volunteers or Duke Eye Center patients and pediatric patients under 18 seen or undergoing clinically indicated evaluation under anesthesia at Duke whose parent/guardian can consent.
Not a fit: Patients with dense media opacities, active ocular infection, or other conditions that prevent obtaining clear OCT images, and those unable to attend the Duke site, are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could make retinal imaging faster and more consistent for uncooperative infants and children, improving screening and longitudinal monitoring.
How similar studies have performed: Prior handheld OCT iterations have successfully imaged the pediatric retina, but the auto-alignment and real-time quality-detection features are novel and are being piloted here.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 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: 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)
Where this trial is running
Durham, North Carolina
- Duke University Eye Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Xi Chen, MD, PhD — Duke University
- Study coordinator: Xi Chen, MD, PhD
- Email: xi2.chen@duke.edu
- Phone: (919) 684-8434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.