Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-02-24 @ 12:34 PM
Study NCT ID:
NCT03753893
Status:
COMPLETED
Last Update Posted:
2022-04-12
First Post:
2018-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Manifestations in Rheumatic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D007638', 'term': 'Keratoconjunctivitis Sicca'}, {'id': 'D014985', 'term': 'Xerophthalmia'}, {'id': 'D005130', 'term': 'Eye Hemorrhage'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D010211', 'term': 'Papilledema'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D015356', 'term': 'Retinal Artery Occlusion'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012173', 'term': 'Retinitis'}, {'id': 'D002825', 'term': 'Chorioretinitis'}, {'id': 'D015863', 'term': 'Iridocyclitis'}, {'id': 'D015423', 'term': 'Scleritis'}, {'id': 'D002832', 'term': 'Choroid Hemorrhage'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D020757', 'term': 'Amaurosis Fugax'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D002833', 'term': 'Choroiditis'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D015866', 'term': 'Uveitis, Posterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015422', 'term': 'Scleral Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2018-11-23', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ocular manifestations of inflammatory rheumatic diseases', 'timeFrame': 'data is collected once per year up to 2020', 'description': 'Prevalence of ocular manifestations of inflammatory rheumatic diseases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uveitis', 'Conjunctivitis', 'Keratoconjunctivitis Sicca', 'Xerophthalmia', 'Eye Hemorrhage', 'Optic Neuritis', 'Papilledema', 'Orbital Diseases', 'Retinal Vein Occlusion', 'Retinal Artery Occlusion', 'Macular Edema', 'Retinitis', 'Chorioretinitis', 'Iridocyclitis', 'Scleritis', 'Choroid Hemorrhage', 'Blindness', 'Amaurosis Fugax']}, 'descriptionModule': {'briefSummary': 'This is a search strategy for determining the prevalence of ocular complications in inflammatory rheumatic diseases for the purposes of a meta analysis.', 'detailedDescription': 'For the purposes of determining the prevalence of ocular complications in inflammatory rheumatic diseases, the following search terms were used: conjunctivitis, keratoconjunctivitis sicca, xerophthalmia, uveitis, eye hemorrhage, optic neuritis, papilledema, orbital disease, retinal artery/vein occlusion, macular edema, retinitis, chorioretinitis, scleritis, iridocyclitis, choroid hemorrhage, blindness and amaurosis fugax.\n\nThese terms were searched in the context of a corresponding inflammatory disease on Medline, Cochrane and Web of Science from their inception (1966, 1991 and 1990 respectively) until the point of study completion.\n\nStudies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in an inflammatory rheumatic disease. Studies were excluded if they were review articles, case reports where all patients experienced the same ocular comorbidity, if different comorbidities were not grouped independently, and if the study reported on fewer than 20 patients. When the same study cohort was used in more than one analysis, the most recent or largest sample-size study was included. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist was used to assess the quality of cohort, case-control, and cross-sectional studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ocular involvement in inflammatory rheumatic disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Studies were included if they provided numerical data of the prevalence or incidence of ocular manifestations in inflammatory rheumatic disease\n\nExclusion Criteria:\n\n* review articles,\n* case reports where all patients experienced the same ocular comorbidity\n* if different comorbidities were not grouped independently\n* if the study reported on fewer than 20 patients'}, 'identificationModule': {'nctId': 'NCT03753893', 'briefTitle': 'Ocular Manifestations in Rheumatic Diseases', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Prevalence of Ocular Manifestations in Inflammatory Rheumatic Diseases', 'orgStudyIdInfo': {'id': 'MTJP001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention used', 'type': 'OTHER', 'description': 'no intervention used'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janet Pope, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Janet Pope', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}