Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT01274702
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2011-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Reconstitution Therapy After Optic Neuritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2011-01-10', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual field', 'timeFrame': '6 months', 'description': 'visual field perimetry and kampimetry at baseline and after 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'structural retinal changes', 'timeFrame': '6 months', 'description': 'Optical coherence Tomography is performe at baselline and after 6 months'}, {'measure': 'Quality of Life', 'timeFrame': '6 months', 'description': 'Quality of life is determined by questionaires at baseline and after 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['History of', 'Patients', 'acute'], 'conditions': ['Optic Neuritis', 'Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '22742888', 'type': 'DERIVED', 'citation': 'Schinzel J, Schwarzlose L, Dietze H, Bartusch K, Weiss S, Ohlraun S, Paul F, Dorr J. Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial. Trials. 2012 Jun 28;13:94. doi: 10.1186/1745-6215-13-94.'}], 'seeAlsoLinks': [{'url': 'https://neurocure.de/ncrc/ueber-uns.html', 'label': 'NeuroCure Clinical Research Center, Charité Berlin, Germany'}]}, 'descriptionModule': {'briefSummary': 'Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.\n\nThe primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.', 'detailedDescription': 'Patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. Group A is instructed to perform software-based visual reconstitution therapy on a home PC daily and regularly for 30 minutes over a period of six month. Group B will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. Patients are blinded to the respective treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Definite Optic Neuritis within 60-180 Days or \\< 12 months before Screening\n* Visus \\> 0.05\n* Visus \\< 0.7 or confirmed visual field deficit\n* Ability to give Informed Consent\n\nExclusion Criteria:\n\n* Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening\n* Additional significant ophthalmological disease\n* Pregnancy\n* History of Epilepsy\n* Significant arterial Hypertension'}, 'identificationModule': {'nctId': 'NCT01274702', 'acronym': 'VISION', 'briefTitle': 'Visual Reconstitution Therapy After Optic Neuritis', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Visual Reconstitution Therapy After Optic Neuritis', 'orgStudyIdInfo': {'id': 'Vision Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Visual Reconstitution Therapy', 'interventionNames': ['Other: Visual Reconstitutions Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saccadic Eye Movement Training', 'interventionNames': ['Other: Saccadic Eye Movement Training']}], 'interventions': [{'name': 'Visual Reconstitutions Therapy', 'type': 'OTHER', 'armGroupLabels': ['Visual Reconstitution Therapy']}, {'name': 'Saccadic Eye Movement Training', 'type': 'OTHER', 'armGroupLabels': ['Saccadic Eye Movement Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Friedemann Paul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Friedemann Paul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beuth Hochschule für Technik Berlin', 'class': 'UNKNOWN'}, {'name': 'NovaVision AG, Zentrum für Sehtherapie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Friedemann Paul', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}