Actively Recruiting
Adaptive Optics Imaging of Outer Retinal Diseases
Led by Food and Drug Administration (FDA) · Updated on 2026-05-08
100
Participants Needed
2
Research Sites
N/A
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 investigating outer retinal diseases, which affect parts of the eye such as photoreceptors, the retinal pigment epithelium, basement membrane, or choroid. The study aims to collect detailed retinal images using adaptive optics to develop new diagnostic tools, biomarkers, and clinical endpoints. Both healthy volunteers and individuals with these diseases are included to support the comparison and understanding of retinal changes over time. Participants will undergo imaging with advanced adaptive optics devices that combine scanning laser ophthalmoscopy and optical coherence tomography. These systems capture high-resolution videos of retinal cells while correcting for eye-related distortions. Imaging will focus on several key areas in the macula and will be repeated over a three-year period to track changes in retinal cell structure and function. During the study, participants will receive imaging sessions where measurements such as photoreceptor density, retinal pigment epithelial cell density, organelle movement, and photoreceptor function will be recorded. Some measurements will be repeated to assess consistency. The study monitors these cellular features to better understand disease progression and to aid future therapy development. Participation may last up to three years with periodic imaging visits.
CONDITIONS
Brief 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 cooperate with instructions during adaptive optics imaging
- Can understand and sign informed consent
- Have been diagnosed with outer retinal disease or condition (for Cohort 2)
You will not qualify if you...
- Have conditions preventing adequate imaging (e.g., unstable fixation, media opacity)
- Have vision correction outside the range of +4 to -8 diopters
- Have a history of adverse reaction to mydriatic drops
- Have narrow iridocorneal angle or history of acute angle closure glaucoma
- Are under direct supervision of specific doctors or NIH/NEI AIs involved in the study
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.
Duration - Up to 3 years
Participants undergo adaptive optics retinal imaging using investigational multimodal AO retinal imaging systems to collect high resolution images and videos of retinal cellular structures.
Multiple imaging sessions over 3 years
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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