Adaptive Optics Retinal Imaging

NCT02317328 | Recruiting

• 2 other identifiers: 15002015-EI-0020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

Eye Disease; Natural History

Outcome Measures

Primary Outcomes (1)

• Qualitative and quantitative assessment of AO images

  Qualitative and quantitative assessment of AO images with comparison of normal and diseased states.

  ongoing

Study Arms (2)

Affected participants

Participants with ocular conditions

Healthy Volunteers

Healthy volunteers

Eligibility Criteria

• Age: 12 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

500 participants with eye diseases and 500 healthy volunteers will be enrolled.

You may qualify if:

• 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).

You may not qualify if:

• Participants will not be eligible if:
• They have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity).
• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Hendrickson A, Drucker D. The development of parafoveal and mid-peripheral human retina. Behav Brain Res. 1992 Jul 31;49(1):21-31. doi: 10.1016/s0166-4328(05)80191-3.

  PMID: 1388798 BACKGROUND

• Wing GL, Blanchard GC, Weiter JJ. The topography and age relationship of lipofuscin concentration in the retinal pigment epithelium. Invest Ophthalmol Vis Sci. 1978 Jul;17(7):601-7.

  PMID: 669891 BACKGROUND

• Fotedar R, Wang JJ, Burlutsky G, Morgan IG, Rose K, Wong TY, Mitchell P. Distribution of axial length and ocular biometry measured using partial coherence laser interferometry (IOL Master) in an older white population. Ophthalmology. 2010 Mar;117(3):417-23. doi: 10.1016/j.ophtha.2009.07.028. Epub 2010 Jan 19.

  PMID: 20031227 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Johnny C Tam, Ph.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel W Claus, R.N.

CONTACT

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

Johnny C Tam, Ph.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2014
• First Posted: December 16, 2014
• Study Start: February 20, 2015
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05-06

Locations

US (1)