Recruiting

Adaptive Optics

Sponsor:

National Eye Institute (NEI)

Code:

NCT02317328

Conditions

Eye Diseases

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Eye Diseases

Healthy Volunteers

Study ID

NCT02317328

Start date

Feb 20, 2015

Status verified date

Aug 6, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Affected participants

Participants with ocular conditions

Healthy Volunteers

Healthy volunteers

Primary outcome measure

  • Qualitative and quantitative assessment of AO images [ Time Frame: ongoing ]

Central Contacts and Locations

Central contacts

Daniel W Claus, R.N.

(301) 451-1621daniel.claus@nih.gov

Johnny C Tam, Ph.D.

(301) 435-7821johnny.tam@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Aug 10, 2026

Last verified

Aug 6, 2026

Keywords

  • Eye Disease
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2026-08-10.