Who is eligible for clinical trial NCT05355415?

Participants must meet the protocol's inclusion criteria for Retinal Degeneration. The stated age range is 21 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05355415 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-06

Adaptive Optics Imaging of Outer Retinal Diseases (NCT05355415)

🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Food and Drug Administration (FDA)

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (6 items).

Location: NIH Clinical Center — Bethesda, Maryland

Age range: 21 Years

🧪 Interventions in This Study

Adaptive optics imaging (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Are 21 years of age or older,
Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
Have been diagnosed with outer retinal disease or condition (Cohort 2).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
Have visual correction outside of the range +4 diopters (D) to -8 D,
Have a history of adverse reaction to mydriatic drops,
Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

NIH Clinical Center — Bethesda, Maryland
Food and Drug Administration — Silver Spring, Maryland

📞 Contact the Study Coordinator

Phone: (301) 796-9320

Email: daniel.hammer@fda.hhs.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Retinal Degeneration clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗