Normal Human Electro-Oculogram

March 3, 2008 updated by: National Eye Institute (NEI)

This study will measure the normal range of the human electro-oculogram (EOG) in people of various age groups. EOGs are recordings of electrical signals generated by the retina (the light-sensitive tissue in the back of the eye) when going from a dark to a bright environment. They provide valuable information about the function of the eye in health and disease. A knowledge of what results are to be expected in tests of normal, healthy eyes will be valuable in assessing EOG results in patients with known or suspected retinal diseases.

Normal volunteers from ages 6 to 65 who have healthy eyes and normal eyesight will participate in this study. Candidates will undergo tests to check vision and the health of the eye. Study participants will then have an electro-oculogram. In this test, eye drops are placed in the eye to enlarge the pupils. Two electrodes (small disks that picks up electrical signals) are attached to the left and right of each eye and one to the forehead. (These are similar to electrodes placed on the body during an electrocardiogram (ECG), which measures electrical signals from the heart.) During the EOG recording, the volunteer looks at the inside of a hollow sphere, following with their eyes small red lights that turn on and off. The background light is also turned on or off during the test. Some volunteers may be asked to repeat the EOG at another time.

Study participants may also be asked to provide a blood sample for tests to study how the immune cells in the blood respond to proteins found in the retina. The response from normal volunteers will be compared with that of patients with eye diseases like retinitis pigmentosa.

Study Overview

Status

Completed

Conditions

Detailed Description

Electro-oculograms (EOGs) will be recorded in volunteers of different age groups with normal visual function. The fast and slow oscillations of the EOG will be studied. For the analysis of fast EOG oscillations, peak-to-peak amplitude (micro V), peak-to-trough ratio, and phase (degrees) will be measured. The analysis of slow EOG oscillations will include measurements of the ratio of light peak to dark trough (Arden ratio), implicit time (latency) of the light peak (ms), and amplitude of the dark trough (micro V).

Study Type

Observational

Enrollment

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Eye Institute (NEI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Subjects must have best corrected visual acuity equal or better than 20/20.

Subjects must have normal visual fields.

Subjects must have normal color vision.

Subjects must have a normal ophthalmological exam.

Subjects should not be subjective to or objective evidence of visual loss.

Subjects cannot have subjective evidence of abnormal night vision or subjective evidence of abnormal light sensitivity.

Subjects cannot have a personal history of non-trivial ocular disease.

Subjects cannot have a family history of hereditary ocular disease.

Subjects cannot have current systemic disease.

Subjects cannot currently take neuropharmacological medication.

Subjects will not be admitted with an abnormal ophthalmological examination.

Subjects will need the ability to cooperate with EOG recording.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1997

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (Estimate)

November 4, 1999

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 970080
  • 97-EI-0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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