Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Part of paid clinical trials in Durham, North Carolina.
- Sponsor
- Duke University
- Study ID
- NCT06841575
- Status
- Recruiting
Conditions
- Eye Diseases
- Glaucoma
- Optic Nerve Diseases
- Retinal Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Month - N/A
- Healthy Volunteers
- Accepted
Interventions
- Auto-aligned OCT — DEVICESwept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
Study Details
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Key Dates
- Start date
- Mar 23, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: Group 1: Healthy adult volunteersHealthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)
- Experimental: Group 2: Adult patients in ophthalmology clinicsAdult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)
- Experimental: Group 3: Pediatric patients in ophthalmology clinicsMinor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)
Primary Outcome Measure
Number of participants with abnormal retinal microanatomy [ Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years ]
Central Contacts
- Xi Chen, MD, PhD(919) 684-8434
- Michelle N McCall, MCAPM, BA(919) 684-0544
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Duke University Eye Center | Durham | North Carolina | 27710 | Anthony Kuo, MD (SUB_INVESTIGATOR) Hafeez Dhalla, PhD (SUB_INVESTIGATOR) |
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