NCT00001610

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2003

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Healthy

Keywords

Standing PotentialFast OscillationSlow OscillationRetinal PigmentEpitheliumElectro-oculogramCellular Immune ResponseRetinal AntigensIRBPS-AntigenNormal Volunteer

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Guideline nine: guidelines on evoked potentials. American Electroencephalographic Society. J Clin Neurophysiol. 1994 Jan;11(1):40-73. No abstract available.

    PMID: 8195426BACKGROUND

  • Steinberg RH. Interactions between the retinal pigment epithelium and the neural retina. Doc Ophthalmol. 1985 Oct 15;60(4):327-46. doi: 10.1007/BF00158922.

    PMID: 3905312BACKGROUND

  • Marmor MF, Zrenner E. Standard for clinical electro-oculography. International Society for Clinical Electrophysiology of Vision. Arch Ophthalmol. 1993 May;111(5):601-4. doi: 10.1001/archopht.1993.01090050035023.

    PMID: 8489436BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

February 1, 1997

Study Completion

March 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-03

Locations

US(1)