Imaging of outer retinal diseases using adaptive optics
Adaptive Optics Imaging of Outer Retinal Diseases
This study is trying to take detailed pictures of the retina in people with outer retinal diseases to help find better ways to diagnose and understand these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Food and Drug Administration (FDA) Federal |
| Locations | 2 sites (Bethesda, Maryland and 1 other locations) |
| Trial ID | NCT05355415 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 and older diagnosed with any type of outer retinal disease.
Not a fit: Patients with conditions that prevent adequate imaging or those with severe visual correction needs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques and treatment monitoring for patients with outer retinal diseases.
How similar studies have performed: Other studies utilizing adaptive optics imaging have shown promise in enhancing the understanding and diagnosis of retinal diseases, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.