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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

Age-Related Macular DegenerationRetinal DegenerationRetinitis PigmentosaHydroxychloroquine RetinopathyCone DystrophyUsher SyndromesLate-Onset Retinal Degeneration

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)

NIH Clinical Center

Bethesda, Maryland, United States

Food and Drug Administration

Silver Spring, Maryland, United States

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NCT05355415

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