Adaptive Optics Retinal Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-120
SponsorNational Eye Institute (NEI)
About this trial
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
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
500 participants with eye diseases and 500 healthy volunteers will be enrolled.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Affected participants
Group B: Healthy Volunteers
Trial outcomes
Primary outcomes
1
Qualitative and quantitative assessment of AO images
Qualitative and quantitative assessment of AO images with comparison of normal and diseased states.
Time frame
ongoingSponsors and contacts
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Source ClinicalTrials.gov