Adaptive Optics Retinal Imaging

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 with 20/20 vision or better.

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.

Study Overview

• Status: Recruiting
• Conditions: Eye Diseases; Healthy Volunteers

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Daniel W Claus, R.N.; Phone Number: (301) 451-1621; Email: daniel.claus@nih.gov
• Study Contact Backup: Name: Johnny C Tam, Ph.D.; Phone Number: (301) 435-7821; Email: johnny.tam@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

primary clinical

Description

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Healthy volunteers
Affected participants; Participants with ocular conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of AO images	Comparison of normal and diseased states.	ongoing

Collaborators and Investigators

• Sponsor: National Eye Institute (NEI)
• Investigators: Principal Investigator: Johnny C Tam, Ph.D., National Eye Institute (NEI)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2015
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: December 13, 2014
• First Posted (Estimated): December 16, 2014

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 28, 2024

More Information

Terms related to this study

• Keywords: Natural History; Eye Disease
• Additional Relevant MeSH Terms: Eye Diseases
• Other Study ID Numbers: 150020; 15-EI-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No