Status:
RECRUITING
Adaptive Optics Imaging of Outer Retinal Diseases
Lead Sponsor:
Food and Drug Administration (FDA)
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Retinal Degeneration
Age-Related Macular Degeneration
Eligibility:
All Genders
21+ years
Brief 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 epit...
Detailed Description
Objective: 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 p...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
- Have visual correction outside of the range +4 diopters (D) to -8 D,
- Have a history of adverse reaction to mydriatic drops,
- Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
- Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 27 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05355415
Start Date
August 27 2021
End Date
August 27 2026
Last Update
April 3 2025
Active Locations (2)
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1
NIH Clinical Center
Bethesda, Maryland, United States, 20810
2
Food and Drug Administration
Silver Spring, Maryland, United States, 20993