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Recruiting NCT05355415

Adaptive Optics Imaging of Outer Retinal Diseases

— Observational Retinal Degeneration Age-Related Macular Degeneration Retinitis Pigmentosa Hydroxychloroquine Retinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adaptive optics imaging.
Who it may be relevant to
Registry conditions: Retinal Degeneration, Age-Related Macular Degeneration, Retinitis Pigmentosa, Hydroxychloroquine Retinopathy. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Photoreceptor (PR) density [Time frame: PR density will be calculated once at the AO imaging session in which PRs are the target.]
  • 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 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-control

Study locations

United States · 2 centers
  • NIH Clinical Center — Bethesda
  • Food and Drug Administration — Silver Spring

Identifiers

NCT: NCT05355415 · 2019-CDRH-074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗