Normal Human Electro-Oculogram

Launched by NATIONAL EYE INSTITUTE (NEI) · Nov 3, 1999

Nctid: NCT00001610

Payload: {"FullStudy"=>{"Rank"=>474092, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "EnrollmentInfo"=>{"EnrollmentCount"=>"150"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"February 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"March 2003", "CompletionDateStruct"=>{"CompletionDate"=>"March 2003"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Standing Potential", "Fast Oscillation", "Slow Oscillation", "Retinal Pigment", "Epithelium", "Electro-oculogram", "Cellular Immune Response", "Retinal Antigens", "IRBP", "S-Antigen", "Normal Volunteer"]}, "ConditionList"=>{"Condition"=>["Healthy"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8195426", "ReferenceType"=>"background", "ReferenceCitation"=>"Guideline nine: guidelines on evoked potentials. American Electroencephalographic Society. J Clin Neurophysiol. 1994 Jan;11(1):40-73. No abstract available."}, {"ReferencePMID"=>"3905312", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}, {"ReferencePMID"=>"8489436", "ReferenceType"=>"background", "ReferenceCitation"=>"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."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.\n\nNormal 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.\n\nStudy 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.", "DetailedDescription"=>"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)."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Subjects must have best corrected visual acuity equal or better than 20/20.\n\nSubjects must have normal visual fields.\n\nSubjects must have normal color vision.\n\nSubjects must have a normal ophthalmological exam.\n\nSubjects should not be subjective to or objective evidence of visual loss.\n\nSubjects cannot have subjective evidence of abnormal night vision or subjective evidence of abnormal light sensitivity.\n\nSubjects cannot have a personal history of non-trivial ocular disease.\n\nSubjects cannot have a family history of hereditary ocular disease.\n\nSubjects cannot have current systemic disease.\n\nSubjects cannot currently take neuropharmacological medication.\n\nSubjects will not be admitted with an abnormal ophthalmological examination.\n\nSubjects will need the ability to cooperate with EOG recording."}, "IdentificationModule"=>{"NCTId"=>"NCT00001610", "BriefTitle"=>"Normal Human Electro-Oculogram", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Normal Human Electro-Oculogram", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970080"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-EI-0080"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Eye Institute (NEI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Eye Institute (NEI)", "LeadSponsorClass"=>"NIH"}}}}}}