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Adaptive Optics Imaging of Outer Retinal Diseases

ConditionsRetinal DegenerationAge-Related Macular DegenerationRetinitis PigmentosaHydroxychloroquine RetinopathyUsher SyndromesLate-Onset Retinal DegenerationCone DystrophyCone Rod DystrophyRod Cone DystrophyRod Dystrophy
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

This trial does not accept healthy volunteers

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 population

All study participants will be recruited from the NIH patient population.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Adaptive optics imaging

    Device

    Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Outer retinal disease1 intervention
Group B: Healthy control1 intervention

Trial outcomes

Primary outcomes

1

Photoreceptor (PR) density

PR density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes or average AOSLO frames.

Time frame
PR density will be calculated once at the AO imaging session in which PRs are the target.
2

Retinal pigment epithelial (RPE) cell density

RPE cell density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes.

Time frame
RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target.
3

RPE cell organelle motility

RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes.

Time frame
RPE motility will be calculated once at the AO imaging session in which RPE cells are the target. For the reproducibility portion of the study, RPE organelle motility will be quantified three times separated by 1-2 weeks.
4

PR cell function

Photoreceptor cell (cone) function will be measured from phase changes between inner segment - outer segment junction and cone outer segment tip signals in a sequence of AO-OCT volumes collected during visible light stimulation.

Time frame
PR function will be calculated once at the AO imaging session in which PR cells are stimulated. For the reproducibility portion of the study, PR cell function will be quantified three times separated by 1-2 weeks.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Food and Drug Administration (FDA)

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov
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