Adaptive Optics Imaging of Outer Retinal Diseases
Launched by FOOD AND DRUG ADMINISTRATION (FDA) · Apr 25, 2022
Trial Information
Current as of November 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Adaptive Optics Imaging of Outer Retinal Diseases," is focused on understanding and diagnosing various outer retinal diseases, such as age-related macular degeneration and retinitis pigmentosa. The goal is to collect advanced retinal images using a special technique called adaptive optics imaging. This technology helps researchers see the outer layers of the retina more clearly, which may lead to better diagnostic methods and treatment options for patients with these conditions.
To participate in this study, individuals must be 21 years or older and have a diagnosed outer retinal disease. They should be able to follow instructions during the imaging process, similar to what happens in a regular eye exam. Participants will undergo imaging sessions, where they can expect to provide consent and cooperate with the imaging procedures. It’s important to note that certain conditions, like severe vision issues or a history of specific eye problems, may exclude someone from joining. The trial is currently recruiting participants and welcomes individuals of all genders.
Gender
ALL
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.
About Food And Drug Administration (Fda)
The Food and Drug Administration (FDA) is a pivotal regulatory agency of the U.S. Department of Health and Human Services, responsible for safeguarding public health by ensuring the safety, efficacy, and security of drugs, biologics, and medical devices. The FDA oversees clinical trials to ensure compliance with regulatory standards, promoting ethical research practices and the protection of human subjects. Through rigorous evaluation and monitoring, the FDA plays a crucial role in advancing medical innovations and facilitating access to safe and effective therapeutic options for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
Silver Spring, Maryland, United States
Patients applied
Trial Officials
Daniel X Hammer, Ph.D.
Principal Investigator
Food and Drug Administration (FDA)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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