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NCT Number: NCT05355415

Adaptive Optics Imaging of Outer Retinal Diseases

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.

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Key information

Conditions

Retinal Degeneration Abnormalities, Multiple Age-Related Macular Degeneration Blindness Cone Dystrophy Cone Rod Dystrophy Cone-Rod Dystrophies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deaf-Blind Disorders Deafness Ear Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Hydroxychloroquine Retinopathy Late-Onset Retinal Degeneration Macular Degeneration Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Rod Cone Dystrophy Rod Dystrophy Sensation Disorders Signs and Symptoms Usher Syndromes Vision Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NIH Clinical Center, Bethesda, Maryland, United States

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About this study

Objective: 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.

Study Population: Up to fifty (50) healthy volunteers without eye disease (Cohort 1) and up to fifty (50) affected participants with any type of outer retinal disease (Cohort 2) will be enrolled.

Design: This is a longitudinal study protocol where participants will be imaged with investigational multimodal AO (mAO) retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels over three years. High resolution OCT and SLO videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. In general, videos of different retinal cellular structures will be acquired from several retinal locations using various imaging modes.

Outcome Measures: The primary outcomes for this protocol are development of new diagnostic methods and disease biomarkers, investigation of cellular morphological and functional changes due to various outer retinal diseases, and development of new AO clinical endpoints for novel therapies.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Adaptive optics imaging

Device

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

Primary outcomes

  1. Photoreceptor (PR) density

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

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

  2. Retinal pigment epithelial (RPE) cell density

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

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

  3. RPE cell organelle motility

    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.

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

  4. PR cell function

    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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel X Hammer, Ph.D.

CONTACT

[email protected]

301-796-9320

Zhuolin Liu, Ph.D.

CONTACT

[email protected]

301-796-7914

Sponsors and collaborators

Lead sponsor

Food and Drug Administration (FDA)

Fed

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 2, 2022
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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