Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT05853003
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}], 'ancestors': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-30', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects', 'timeFrame': 'over 1 year', 'description': 'comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Optic Neuropathy']}, 'descriptionModule': {'briefSummary': 'assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.', 'detailedDescription': 'Evaluating the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.by measuring the diameter of optic nerve at certain site and comparing it to healthy subjects measurements and to asses NMUS ability to detect optic neuropathy in lupus patients in comparison to conventional techniques including opthalmologist evaluation and visual evoked potential'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) and another group of an apparently healthy subjects will be added to the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* group of SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) with or without symptoms of optic neuropathy\n* another group of apparently healthy subjects with no. history of chronic conditions\n\nExclusion Criteria:\n\n* Any patient with optic neuritis due to causes other than lupus was excluded from the study: ex.\n\n * Post traumatic neuropathy\n * Purely degenerative neuropathy\n * Diabetic neuropathy\n * Toxic neuropathy\n * Neuropathies related to infections\n * Drug induced neuropathy e.g: quinine and some antibiotics, ethambutol\n * Infections e.g. measles, mumps, Lyme disease, etc.\n * Other Autoimmune diseases like sarcoidosis, B.D\n * Tumor causing Inc. intracranial tension.'}, 'identificationModule': {'nctId': 'NCT05853003', 'briefTitle': 'Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE', 'orgStudyIdInfo': {'id': 'bending'}}, 'contactsLocationsModule': {'locations': [{'zip': '12222', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Amira elsonbaty, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amira M elSonbaty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Amira Elsonbaty', 'investigatorFullName': 'Amira M elSonbaty', 'investigatorAffiliation': 'Assiut University'}}}}