NCT05355415 Adaptive Optics Imaging of Outer Retinal Diseases
| NCT ID | NCT05355415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Food and Drug Administration (FDA) |
| Condition | Retinal Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-08-27 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-08-27 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Daniel X Hammer, Ph.D.
PRINCIPAL INVESTIGATOR
Food and Drug Administration (FDA)
Frequently Asked Questions
Who can join the NCT05355415 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Retinal Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05355415 currently recruiting?
Yes, NCT05355415 is actively recruiting participants. Contact the research team at daniel.hammer@fda.hhs.gov for enrollment information.
Where is the NCT05355415 trial being conducted?
This trial is being conducted at Bethesda, United States, Silver Spring, United States.
Who is sponsoring the NCT05355415 clinical trial?
NCT05355415 is sponsored by Food and Drug Administration (FDA). The principal investigator is Daniel X Hammer, Ph.D. at Food and Drug Administration (FDA). The trial plans to enroll 100 participants.