Imaging of outer retinal diseases using adaptive optics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect adaptive optics retinal images from individuals with outer retinal diseases, such as retinal degeneration and age-related macular degeneration. The study will enroll up to 100 participants, including healthy volunteers and those diagnosed with outer retinal conditions. Over three years, participants will undergo imaging using advanced multimodal adaptive optics systems to capture high-resolution videos of retinal structures. The goal is to develop new diagnostic methods, biomarkers, and clinical endpoints for these diseases.

Why it matters

Who can join: the full rules

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.

Where it's running

• NIH Clinical Center
  Bethesda, Maryland, United States Recruiting
• Food and Drug Administration
  Silver Spring, Maryland, United States Recruiting

Study contacts

• Principal investigator: Daniel X Hammer, Ph.D. — Food and Drug Administration (FDA)
• Study coordinator: Daniel X Hammer, Ph.D.
• Email: daniel.hammer@fda.hhs.gov
• Phone: 301-796-9320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.