The Focal Electro-Oculogram in Macular Disease

NCT02225119 | Completed

• 2 other identifiers: 14017114-EI-0171
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Maculopathies are eye conditions that affect the center of the retina. Retina health depends on the retinal pigment epithelium (RPE), a layer behind the retina. A new test may measure the health of the central retina and RPE. Objective: \- To use the focal electro-oculogram (EOG) test to understand how the central retina and RPE are affected in maculopathies. Eligibility:

• People at least 10 years old with a maculopathy.
• Healthy volunteers with visual acuity of 20/20 or better in at least one eye. Design:
• Participants will be screened with medical and eye history and an eye exam. Pictures will be taken of the eyes.
• Their eyes may be dilated.
• They may have a field test. They will look into a lens and press a button when they see a light. First, they may sit in the dark for 40 minutes.
• Participants will have 1-7 visits over 18 months.
• Their vision will be tested and eye pressure measured.
• Their pupils will be dilated with eye drops and researchers may take pictures of the retina and the inside of the eye, and measure the thickness of the retina.
• Participants will have an electro-oculogram. They will look at a 2 LED lights and follow them back and forth for 10 seconds once per minute. Participants will be in darkness for 15 minutes and in light for 20 minutes. One skin electrode will be placed on the nose and one next to the eye.
• Participants with maculopathy will also have:
• Field test.
• Electroretinogram. Participants will get numbing eye drops and special contact lenses. A small metal electrode will be taped to the forehead. Participants will watch flashing lights and try not to blink. First, they may sit in the dark for 40 minutes.

Conditions

Macular Degeneration; Age-Related Macular Degeneration

Keywords

Retinal Images; Retinal Pigment Epithelium; Natural History

Outcome Measures

Primary Outcomes (1)

• develop method for recording focal EOG

  to develop a method for recording the focal EOG in response to a central light stimulus

  up to 6 months

Secondary Outcomes (1)

• establish the normal range for the focal EOG and determine the inter-session and intra-session variabilities of this test

  up to 18 months

Study Arms (2)

Affected

Participants with macular disease

Unaffected

Healthy volunteers

Eligibility Criteria

• Age: 10 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 50 healthy volunteers and 80 participants, age 10 or older, with macular disease; examples of such disorders include Stargardt s disease and age-related macular degeneration (AMD). NIH employees meeting the eligibility criteria may participate in this study.

You may qualify if:

• Participant must be 10 years of age or older.
• Participant (or legal guardian) must understand and sign the protocol s informed consent document.
• Participant must be able to cooperate with the testing required for this study.
• For Participants with macular disease only:
• Participant must have macular disease, defined as evidence of loss of centrally mediated retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.
• Participant must have a measurable visual acuity.
• For Healthy Volunteers only:
• Participant must have visual acuity of 20/20 or better in at least one eye.

You may not qualify if:

• \) Participant with pre-retinal media opacities that would prevent focal light presentation.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Brett G Jeffrey, Ph.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 23, 2014
• First Posted: August 26, 2014
• Study Start: February 6, 2015
• Primary Completion: May 7, 2019
• Study Completion: February 28, 2020
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)