| NCT ID | NCT02317328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Eye Institute (NEI) |
| Condition | Eye Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2015-02-20 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 1,000 participants in total. It began in 2015-02-20 with a primary completion date of 2028-03-31.
⚠ 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
Background: \- By the time diseases of the retina are detected, serious damage has often already been done. Researchers want to find better ways of viewing the retina. One way called adaptive optics may help detect problems earlier. Objectives: \- To study if adaptive optics can help find better ways to diagnose, treat, and manage retinal diseases. Eligibility: * People over age 12 with an eye disease. * Healthy volunteers over age 12. Design: * Participants will be screened with medical history and eye exams. These may include dilating pupils and taking pictures of the eyes. * Participants will have 1 or more study visits. They will have: * Medical and eye history. * Questions about their medications. * Eye exam including pupil dilation. * Adaptive optics imaging. After dilation, participants sit still while looking into an adaptive optics instrument. They look at specific places and images are taken of their retina. * They may also have: * More images. * Perimetry. Participants look into a lens and press a button when they see a light. * Color vision tests. * Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be put on their forehead. They will look at flashing lights and try not to blink.
Eligibility Criteria
* INCLUSION CRITERIA: Participants will be eligible if they: * Are 12 years of age or older. * Have the ability to cooperate with an eye exam and adaptive optics imaging. * Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children. * Have an eye disease or are a healthy volunteer with a normal eye exam (no visually-significant eye findings on examination). EXCLUSION CRITERIA: Participants will not be eligible if: -They have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity). EXCLUSION CRITERIA FOR FLUORESCEIN AND/OR INDOCYANINE GREEN IMAGING Partaicipants are not eligible for fluorescein and/or indocyanine green imaging if they: * Are under 18 years of age. * For participants who will undergo fluorescein imaging have a history of adverse reaction to fluorescein. * For participants who will undergo indocyanine green imaging have a history of adverse reaction to indocyanine green dye, know or suspected allergies to iodine or shellfish.
Contact & Investigator
Johnny C Tam, Ph.D.
PRINCIPAL INVESTIGATOR
National Eye Institute (NEI)
Frequently Asked Questions
Who can join the NCT02317328 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 120 Years, studying Eye Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02317328 currently recruiting?
Yes, NCT02317328 is actively recruiting participants. Contact the research team at daniel.claus@nih.gov for enrollment information.
Where is the NCT02317328 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT02317328 clinical trial?
NCT02317328 is sponsored by National Eye Institute (NEI). The principal investigator is Johnny C Tam, Ph.D. at National Eye Institute (NEI). The trial plans to enroll 1,000 participants.