Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-06 @ 3:10 PM
Study NCT ID:
NCT02821767
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History, Pathogenesis, and Outcome of Ocular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12-19', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No formal outcomes will be measured; however, the clinical assessments of enrolled participants can be used to measure the response to standard treatment.', 'timeFrame': 'ongoing', 'description': 'response to standard care of treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eye Disease', 'Natural History'], 'conditions': ['Eye Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2016-EI-0134.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe National Eye Institute (NEI) wants to evaluate and provide standard treatment to people with eye diseases.\n\nObjective:\n\nTo examine and treat people with eye diseases and learn more about eye diseases and how they are inherited.\n\nEligibility:\n\nPeople with eye diseases who can give consent or have a guardian who can consent for them. Asymptomatic first-degree relatives willing to provide a blood sample may also be enrolled for the purpose of genetic testing.\n\nDesign:\n\nParticipants will be screened with an eye exam.\n\nParticipants will have 1-12 visits per year depending on their eye disease for up to 5 years. Visits last about 4 hours and could include:\n\nMedical and family history\n\nPhysical exam\n\nEye exam and photography.\n\nOculography: They put on contact lenses or goggles. They watch spots on a computer\n\nscreen for 20-30 minutes.\n\nElectrooculography: Small metal disks are placed on the skin next to both eyes. They look left\n\nand right in the dark and light for about 30 minutes.\n\nElectroretinography: They sit in the dark with their eyes patched. A small metal disk is taped\n\nto the forehead. After 30 minutes, the patches are removed and contact lenses put in. They\n\nwatch flashing lights.\n\nFluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is\n\ninjected through the tube and travels up the blood vessels in the eyes. Pictures are taken of the\n\neyes.\n\nImmunosuppressive treatment\n\nEye cell sample: Samples are obtained from swabbing, pressing paper on, or taking a small\n\nbiopsy sample from the surface of the eye.\n\nBlood tests\n\nSkin, tear, urine, saliva, stool, or hair sample\n\nExam under anesthesia for some children\n\nAt each visit participants could get medications, eye drops, eye injections, laser treatments, or surgery.\n\n...', 'detailedDescription': 'The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions.\n\nObjective: The primary objective of this protocol is to collect data and specimens generated\n\nthrough clinical care procedures. Through this primary objective, the secondary objectives (establish a resource of patients with ocular conditions to facilitate recruitment into new research protocols at the NEI, gain additional knowledge about the course of specific ocular diseases and characterize the natural history of such diseases (to generate hypotheses for future clinical research studies), and evaluate the effects of standard of care treatments) may be achieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Clinical', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nTo be eligible, the following inclusion criteria must be met, where applicable.\n\n1. Have a diagnosed, undiagnosed or suspected eye disease.\n2. Have the ability to understand and sign an informed consent or have a parent/legal guardian do so if they are minor children or a legally authorized representative to provide consent for adults without consent capacity.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present.\n\n1. Are unwilling to give informed consent or assent when applicable.\n2. Are unwilling or unable to be followed as clinically indicated.\n3. Have a systemic disease that compromises the ability of NEI clinicians to provide adequate ophthalmologic examination or treatment.'}, 'identificationModule': {'nctId': 'NCT02821767', 'briefTitle': 'Natural History, Pathogenesis, and Outcome of Ocular Disorders', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders', 'orgStudyIdInfo': {'id': '160134'}, 'secondaryIdInfos': [{'id': '16-EI-0134'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'subjects with diagnosed or undiagnosed ocular conditions and/or their first-degree relatives'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'prpl@cc.nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY8664111010'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Awilda V Holland, R.N.', 'role': 'CONTACT', 'email': 'aholland@nei.nih.gov', 'phone': '(301) 435-1831'}], 'overallOfficials': [{'name': 'Awilda V Holland, R.N.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Eye Institute (NEI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}