Adaptive Optics Imaging of Outer Retinal Diseases
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
View:
• Are 21 years of age or older,
• Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
• Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
• Have been diagnosed with outer retinal disease or condition (Cohort 2).
Locations
United States
Maryland
NIH Clinical Center
RECRUITING
Bethesda
Food and Drug Administration
RECRUITING
Silver Spring
Contact Information
Primary
Daniel X Hammer, Ph.D.
daniel.hammer@fda.hhs.gov
301-796-9320
Backup
Zhuolin Liu, Ph.D.
zhuolin.liu@fda.hhs.gov
301-796-7914
Time Frame
Start Date: 2021-08-27
Estimated Completion Date: 2026-08-27
Participants
Target number of participants: 100
Treatments
Outer retinal disease
Subjects with outer retinal disease affecting the photoreceptor-retinal pigment epithelium complex will be classified by clinical exam by an experienced retina specialist. Outer retinal disease subjects will undergo adaptive optics (AO) imaging of several macular locations.
Healthy control
Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases.
Related Therapeutic Areas
Sponsors
Leads: Food and Drug Administration (FDA)
Collaborators: National Eye Institute (NEI)