Actively Recruiting
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Led by Duke University · Updated on 2026-03-25
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new handheld optical coherence tomography (OCT) device designed to automatically align with the eye to capture detailed retinal images. This pilot study aims to assess this advanced imaging technology in healthy adult volunteers, adult patients, and pediatric patients with eye and retinal diseases, addressing current challenges in imaging uncooperative patients, especially children. The study is observational and led by Duke University, focusing on improving imaging speed, alignment, and data quality for retinal assessment. The study uses a Swept Source OCT system with enhanced hand-held probe technology that auto-aligns to the patient’s eye and detects image quality in real time, automatically saving optimal images. Participants include 20 healthy adults, 20 adult patients, and 10 pediatric patients from ophthalmology clinics. Imaging will be performed during clinical visits, with up to four single imaging sessions over two years to capture detailed retinal structure and blood flow. Participants will undergo retinal imaging using the handheld OCT device during their clinical visits. Researchers will analyze images for retinal microanatomy abnormalities and retinal thickness at specific eye regions, collecting data securely for further analysis. The study will monitor outcomes over multiple sessions for up to two years, with no known risks reported from prior handheld OCT use. The total participation duration depends on the number of imaging sessions completed within the study timeframe.
CONDITIONS
Brief Title
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult volunteers able and willing to consent, aged more than 18 years without known eye issues except refractive error
- Adult patients in ophthalmology clinics able and willing to consent, aged more than 18 years
- Pediatric patients under 18 years in ophthalmology clinics or undergoing clinically indicated anesthesia exams, with parent or guardian able and willing to consent
- Health care provider agrees that study personnel can contact the subject or parent/legal guardian
You will not qualify if you...
- Students or employees under direct supervision of the investigators
- Subjects with prior problems with pupil dilation
- Pregnant women if receiving pupil-dilating drops
- Adult patients with health or eye conditions preventing eye examination or retinal imaging, such as corneal opacity or cataract
- Pediatric participants whose parent or guardian is unwilling or unable to provide consent
- Pediatric patients with health or eye conditions preventing eye examination or retinal imaging, such as corneal opacity or cataract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo retinal imaging using a handheld OCT device with auto-alignment technology during clinical visits.
Up to 4 imaging sessions at clinical visits over 2 years
Trial Site Locations
Total: 1 location
1
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
X
Xi Chen, MD, PhD
M
Michelle N McCall, MCAPM, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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