RECRUITING

Adaptive Optics Imaging of Outer Retinal Diseases

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Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adaptive Optics Imaging of Outer Retinal Diseases

Quick Facts

Study Start:2021-08-27
Study Completion:2024-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05355415

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Are 21 years of age or older,
  2. 2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
  3. 3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
  4. 4. Have been diagnosed with outer retinal disease or condition (Cohort 2).
  1. 1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
  2. 2. Have visual correction outside of the range +4 diopters (D) to -8 D,
  3. 3. Have a history of adverse reaction to mydriatic drops,
  4. 4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
  5. 5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

Contacts and Locations

Study Contact

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

Principal Investigator

Daniel X Hammer, Ph.D.
PRINCIPAL_INVESTIGATOR
Food and Drug Administration (FDA)

Study Locations (Sites)

NIH Clinical Center
Bethesda, Maryland, 20810
United States
Food and Drug Administration
Silver Spring, Maryland, 20993
United States

Collaborators and Investigators

Sponsor: Food and Drug Administration (FDA)

  • Daniel X Hammer, Ph.D., PRINCIPAL_INVESTIGATOR, Food and Drug Administration (FDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-27
Study Completion Date2024-04-25

Study Record Updates

Study Start Date2021-08-27
Study Completion Date2024-04-25

Terms related to this study

Additional Relevant MeSH Terms

  • 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