Adaptive Optics Retinal Imaging

National Institutes of Health (NIH)

Status

Enrolling

Conditions

Healthy Volunteers

Eye Diseases

Study type

Observational

Funder types

NIH

Identifiers

NCT02317328

150020

15-EI-0020

Details and patient eligibility

About

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.

Full description

Objective: The objective of this protocol is to collect and assess adaptive optics (AO) retinal images of normal and diseased eyes.

Study Population: Three hundred and fifty (350) participants with eye diseases and 250 normal volunteers will be enrolled.

Design: This is an observational protocol which will enroll 350 participants with various eye diseases and 250 age-matched healthy volunteers over five years. In general, participants will undergo a complete ophthalmic examination including assessments of visual acuity, intraocular pressure, and a dilated ocular examination. Imaging will be performed using adaptive optics instruments deployed in the NEI Eye Clinic.

Outcome Measures: The primary outcome for this protocol is qualitative and quantitative assessment of the AO images with comparisons of normal and diseased states.

Enrollment

1,000 estimated patients

Sex

All

Ages

12 to 120 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.