Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-03-05 @ 9:38 PM
Study NCT ID:
NCT02573792
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2015-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Coherence Tomography and Optic Neuritis (OCTON)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-20', 'studyFirstSubmitDate': '2015-10-09', 'studyFirstSubmitQcDate': '2015-10-09', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the OCT, expressed as a percentage, for the etiological diagnosis of optical neuritis', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['First onset of optical neuritis'], 'conditions': ['Optical Neuritis']}, 'descriptionModule': {'briefSummary': "Optic neuritis (ON) can remain isolated or reveal a widespread and chronic disease of the central nervous system (CNS), a multiple sclerosis (MS) or, more rarely, a Devic's neuromyelitis optica (NMO) or a systemic disease.\n\nThe optical coherence tomography (OCT) is a retinal imaging technique to measure the thickness of the retina and its different layers with an accuracy of 4-6 µM.\n\nCostello et al have shown that approximately 75% of 54 MS patients have developed within 3 to 6 months after a ON a loss of 10 to 40 µM in the thickness of the peripapillary retinal nerve fiber layer (RNFL).\n\nThe etiologic diagnosis of ON has been transformed in recent years. MS can now be diagnosed by McDonald's MRI criteria and NMO by the AQP4 antibodies (anti-aquaporin- 4) antibodies and the anti-MOG (myelin-oligodendrocyte glycoprotein) antibodies.\n\nThe diagnosis and prognosis value of the OCT in patients with ON is not well known"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen at the Adolphe de Rothschild ophthalmological foundation for the first onset of an optical neuritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first onset of an optical neuritis lasting for less than 3 months\n\nExclusion Criteria:\n\n* Contra-indication to MRI\n* Patient opposed to participation in the study\n* Pregnant or lactating woman\n* Patient under a measure of legal protection\n* Absence of affiliation to social security or universal health coverage (CMU)'}, 'identificationModule': {'nctId': 'NCT02573792', 'acronym': 'OCTON', 'briefTitle': 'Optical Coherence Tomography and Optic Neuritis (OCTON)', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Optical Coherence Tomography for the Etiological Diagnosis of Inflammatory Optic Neuritis', 'orgStudyIdInfo': {'id': 'RDS_2015_21'}}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}