RecruitingNCT05355415
Adaptive Optics Imaging of Outer Retinal Diseases
Sponsor
Food and Drug Administration (FDA)
Enrollment
100 participants
Start Date
Aug 27, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 21 Years
Inclusion Criteria4
- 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 Criteria5
- 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.
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Interventions
DEVICEAdaptive optics imaging
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05355415
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