Adaptive Optics Imaging of Outer Retinal Diseases

NCT ID: NCT05355415

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2026-08-27

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.

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Adaptive optics imaging

Intervention Type: DEVICE

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

Healthy control

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

Adaptive optics imaging

Intervention Type: DEVICE

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

Interventions

Adaptive optics imaging

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Are 21 years of age or older,

2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),

3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and

4. Have been diagnosed with outer retinal disease or condition (Cohort 2).

Exclusion Criteria

1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),

2. Have visual correction outside of the range +4 diopters (D) to -8 D,

3. Have a history of adverse reaction to mydriatic drops,

4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or

5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: lead

Responsible Party

Daniel X. Hammer

Deputy Director, Division of Biomedical Physics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel X Hammer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Food and Drug Administration (FDA)

Locations

NIH Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Food and Drug Administration

Silver Spring, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel X Hammer, Ph.D.

Role: CONTACT

daniel.hammer@fda.hhs.gov

301-796-9320

Zhuolin Liu, Ph.D.

Role: CONTACT

zhuolin.liu@fda.hhs.gov

301-796-7914

Facility Contacts

Catherine Cukras, M.D., Ph.D.

Role: primary

cukrasc@nei.nih.gov

301-435-5061

Daniel X Hammer, Ph.D.

Role: primary

daniel.hammer@fda.hhs.gov

301-796-9320

Zhuolin Liu, Ph.D.

Role: backup

zhuolin.liu@fda.hhs.gov

301-796-7914

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2019-CDRH-074

Identifier Type: -

Identifier Source: org_study_id