Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT02085850
Status:
UNKNOWN
Last Update Posted:
2014-03-13
First Post:
2014-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1375}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2014-03-11', 'studyFirstSubmitQcDate': '2014-03-11', 'lastUpdatePostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Glaucoma', 'timeFrame': 'Day 0'}, {'measure': 'Progression of Glaucoma', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Aim 1: To determine the incidence of glaucoma in Ghana in subjects previously found to be non-glaucomatous in the Tema Eye Survey.\n\nAim 2: To characterise the progression of glaucoma and the outcomes of subjects diagnosed with glaucoma in the Tema Eye Survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- glaucomatous and non-glaucomatous patients previously seen in the Tema Eye Survey who are selected and invited to participate\n\nExclusion Criteria:\n\n\\- patients not previously seen in the Tema Eye Survey'}, 'identificationModule': {'nctId': 'NCT02085850', 'briefTitle': 'Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Tema Christian Eye Center'}, 'officialTitle': 'Incidence and Progression of Glaucoma in the Tema Eye Survey Cohort', 'orgStudyIdInfo': {'id': 'TCEC 066/13-14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects identified in the Tema Eye Survey', 'description': 'Subjects identified in the Tema Eye Survey'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tema', 'country': 'Ghana', 'facility': 'Tema Christian Eye Center', 'geoPoint': {'lat': 5.6698, 'lon': -0.01657}}], 'overallOfficials': [{'name': 'Alexander Spratt, MBBCh FRCOphth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tema Christian Eye Center'}, {'name': 'Donald L Budenz, MD MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tema Christian Eye Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alex Spratt', 'investigatorAffiliation': 'Tema Christian Eye Center'}}}}