Actively Recruiting
Adaptive Optics Imaging of Outer Retinal Diseases Collecting High-Resolution Retinal Images to Develop New Diagnostic Methods Studying Photoreceptor and Retinal Pigment Epithelial Changes in Outer Retinal Diseases
Led by Food and Drug Administration (FDA) · Updated on 2026-05-08
100
Participants Needed
2
Research Sites
370 weeks
Total Duration
On this page
Sponsors
F
Food and Drug Administration (FDA)
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating adaptive optics (AO) retinal imaging in people with outer retinal diseases, which affect parts of the retina including photoreceptors, retinal pigment epithelium (RPE), basement membrane, or choroid. The study aims to create new diagnostic methods, biomarkers, and clinical endpoints to better understand and track these diseases over time. Participants will undergo imaging with advanced AO retinal devices combining scanning laser ophthalmoscopy and optical coherence tomography. These imaging sessions will capture high-resolution videos and images of various retinal cells from multiple locations. The study includes up to 50 healthy volunteers and 50 individuals with outer retinal diseases. Imaging will be performed repeatedly over three years to observe cellular changes and evaluate new clinical measures. During the study, researchers will assess photoreceptor and RPE cell density, RPE cell organelle movement, and photoreceptor function using the AO imaging data. Some measurements will be repeated multiple times within 1 to 2 weeks to ensure consistency. The study focuses on monitoring cellular structure and function changes related to retinal diseases and developing improved diagnostic and therapeutic endpoints.
CONDITIONS
Official Title
Adaptive Optics Imaging of Outer Retinal Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Are 21 years of age or older
- Can follow instructions during adaptive optics imaging similar to a clinical eye exam
- Can understand and sign informed consent (non-English speakers excluded)
- Have been diagnosed with an outer retinal disease or condition (for affected group)
You will not qualify if you...
- Have a condition preventing adequate imaging such as unstable fixation or eye media opacity
- Have vision correction outside the range of +4 to -8 diopters
- Have a history of allergic reaction to mydriatic eye drops
- Have narrow iridocorneal angle or a history of acute angle closure glaucoma
- Are working directly under supervision of specified doctors or NIH/NEI principal investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NIH Clinical Center
Bethesda, Maryland, United States, 20810
Actively Recruiting
2
Food and Drug Administration
Silver Spring, Maryland, United States, 20993
Actively Recruiting
Research Team
D
Daniel X Hammer, Ph.D.
Z
Zhuolin Liu, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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