Adaptive Optics Imaging of Outer Retinal Diseases

NCT05355415 | Recruiting FDA Device

• 1 other identifier: 2019-CDRH-074
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinal Degeneration; Age-Related Macular Degeneration; Retinitis Pigmentosa; Hydroxychloroquine Retinopathy; Usher Syndromes; Late-Onset Retinal Degeneration; Cone Dystrophy; Cone Rod Dystrophy; Rod Cone Dystrophy; Rod Dystrophy

Outcome Measures

Primary Outcomes (4)

• Photoreceptor (PR) density

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

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

• Retinal pigment epithelial (RPE) cell density

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

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

• 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.

  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.

• 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.

  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.

Study Arms (2)

Outer retinal disease

Subjects with outer retinal disease affecting the photoreceptor-retinal pigment epithelium complex will be classified by clinical exam by an experienced retina specialist. Outer retinal disease subjects will undergo adaptive optics (AO) imaging of several macular locations.

Device: Adaptive optics imaging

Healthy control

Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases.

Device: Adaptive optics imaging

Interventions

Adaptive optics imaging DEVICE

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

Healthy control; Outer retinal disease

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Food and Drug Administration (FDA): lead
• National Eye Institute (NEI): collaborator

Study Sites (2)

NIH Clinical Center

Bethesda, Maryland, 20810, United States

RECRUITING

Food and Drug Administration

Silver Spring, Maryland, 20993, United States

RECRUITING

MeSH Terms

Conditions

Retinal Degeneration; Macular Degeneration; Retinitis Pigmentosa; Usher Syndromes; Late-Onset Retinal Degeneration; Cone Dystrophy; Cone-Rod Dystrophies

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases; Retinal Dystrophies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Deaf-Blind Disorders; Deafness; Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss, Sensorineural; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Vision Disorders; Abnormalities, Multiple; Congenital Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel X Hammer, Ph.D.

  Food and Drug Administration (FDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel X Hammer, Ph.D.

CONTACT

301-796-9320; daniel.hammer@fda.hhs.gov

Zhuolin Liu, Ph.D.

CONTACT

301-796-7914; zhuolin.liu@fda.hhs.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Division of Biomedical Physics

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: May 2, 2022
• Study Start: August 27, 2021
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: For the duration of the study.
• Access Criteria: Available upon request.

Locations

US (2)