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RecruitingNCT05355415

Adaptive Optics Imaging of Outer Retinal Diseases

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Plain-language summary for patients

Trial Parameters

ConditionRetinal Degeneration
SponsorFood and Drug Administration (FDA)
Study TypeOBSERVATIONAL
PhaseN/A
Enrollment100
SexALL
Min Age21 Years
Max AgeN/A
Start Date2021-08-27
Completion2026-08-27
Interventions
Adaptive optics imaging

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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 epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Eligibility Criteria

Inclusion Criteria: 1. Are 21 years of age or older, 2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam), 3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and 4. Have been diagnosed with outer retinal disease or condition (Cohort 2). Exclusion Criteria: 1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity), 2. Have visual correction outside of the range +4 diopters (D) to -8 D, 3. Have a history of adverse reaction to mydriatic drops, 4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or 5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

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