Adaptive Optics Imaging of Outer Retinal Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorFood and Drug Administration (FDA)

About this trial

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

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Adaptive optics imaging

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Food and Drug Administration (FDA)

Lead sponsor

National Eye Institute (NEI)

Collaborator