Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-06 @ 8:03 AM
Study NCT ID:
NCT03068702
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2017-02-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2017-02-22', 'studyFirstSubmitQcDate': '2017-03-01', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vascular changes seen in the macular vasculature of people with sickle cell disease/ trait as compared to macular vasculature of normal macula.', 'timeFrame': 'through study completion, an average of one year', 'description': 'in this angiography the delicate vasculature of the macula can be clearly visualized and documented.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sickle Cell Retinopathy']}, 'descriptionModule': {'briefSummary': 'Sickle cell maculopathy was sparingly mentioned in the literature before despite the fact that sickle cell disease or sickle cell trait is common in people of many areas of the world. This study shows that OCTA is a very valuable, non invasive, office procedure that may well be used in diagnosing this disease.', 'detailedDescription': 'this is a clinical study of two African Canadian patients that were diagnosed with sickle cell trait. I used OCTA to show macular vascular occlusions that usually happen with this disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'African Canadian adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: people with sickle cell trait or sickle cell disease -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03068702', 'acronym': 'OCTA', 'briefTitle': 'New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA)', 'organization': {'class': 'OTHER', 'fullName': 'Dr. S.S. Michel Clinic'}, 'officialTitle': 'New, Previously Unknown, Uses of Optical Coherence Tomography Angiography (OCTA): Sickle Cell Maculopathy', 'orgStudyIdInfo': {'id': 'Optical Coherence Tomography'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'African Canadians', 'description': 'African Canadians with sickle cell disease maculopathy diagnosed by OCTA.', 'interventionNames': ['Device: Optical Coherence Tomography Angiography']}], 'interventions': [{'name': 'Optical Coherence Tomography Angiography', 'type': 'DEVICE', 'armGroupLabels': ['African Canadians']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'shawkat s Michel, MD, FRCS Ed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. S.S. Michel Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Shawkat Michel', 'investigatorAffiliation': 'Dr. S.S. Michel Clinic'}}}}