Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-20 @ 12:08 AM
Study NCT ID:
NCT03316092
Status:
COMPLETED
Last Update Posted:
2017-10-23
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-19', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'optical coherence tomography (OCT) is a very reliable, accessible and documented way for monitoring all people who are to use or have been using oral Hydroxychloroquine', 'timeFrame': 'Ten years', 'description': 'OCT would very much help in selecting patients who may safely use oral Hydroxychloroquine. It is also the most preferred way so far for monitoring all patients who use oral Hydroxychloroquine to prevent serious and bilateral ocular side effects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hydroxychloroquine Toxicity']}, 'descriptionModule': {'briefSummary': 'Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this medication are very serious and causes loss of central vision. In most patients these side effects are dose related, cumulative. This means that the risk of side effects would increase in all patients with continued use of the medication. In few people use of the medication would not be recommended if they have some bilateral macular problems. This is because the side effects of this medication does cause serious degredation of the macula in both eyes.', 'detailedDescription': 'The ocular side effects of Hydroxychloroquine has been known for long time. Due to the seriousness of these side effects all possible efforts were done to prevent them. Preventing these side effects would ideally need prior screening of all patients who are to use oral Hydroxychloroquine. If patients are not screened prior to oral Hydroxychloroquine use they should be examined as soon as possible after starting this medication. Advances in technology, specifically the advent of optical coherence tomography, made screening and monitoring for Hydroxychloroquine toxicity much more easier and reliable meantime.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients whose doctors decide to treat them with oral Hydroxychloroquine. This medication is very popular in treating patients with rheumatoid arthritis and some other auto-immune diseases.', 'eligibilityCriteria': 'Inclusion Criteria: all patients who need treatment with oral Hydroxychloroquine.\n\n\\-\n\nExclusion Criteria: patients who are not using oral Hydroxychloroquine.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03316092', 'briefTitle': 'Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.', 'organization': {'class': 'OTHER', 'fullName': 'Dr. S.S. Michel Clinic'}, 'officialTitle': 'Update on Monitoring and Preventing Hydroxychloroquine Toxicity.', 'orgStudyIdInfo': {'id': 'Ocular Plaquenil Toxicity'}}, 'armsInterventionsModule': {'interventions': [{'name': 'optical coherence tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'screening and monitoring all patients who are to use or have been using oral Hydroxychloroquine'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5R5W9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Dr. S.S. Michel Clinic', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'shawkat s michel, FRCS Ed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. S.S. Michel Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}