Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 11:47 AM
Study NCT ID:
NCT02003235
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2013-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Device for Treatment of Amblyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2013-12-01', 'studyFirstSubmitQcDate': '2013-12-01', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in VA in amblyopic eye', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amblyopia'], 'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.\n\nThe effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRefractive or Strabismic Amblyopia, with best corrected visual acuity.\n\n(1) Refractive Amblyopia, visual acuity score \\<6:15 (worse then)\n\n* or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30\n\nExclusion Criteria:\n\nDiagnosed with epilepsy, recently treated with occlusion or penalization therapy'}, 'identificationModule': {'nctId': 'NCT02003235', 'briefTitle': 'Assessment of Device for Treatment of Amblyopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Visior Technologies Ltd.'}, 'orgStudyIdInfo': {'id': 'RV-TMSC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Daily watching videos using Reviview™, a dichoptic video display device', 'interventionNames': ['Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min']}], 'interventions': [{'name': 'Daily watching videos using Reviview™, a dichoptic video display device, for 60 min', 'type': 'DEVICE', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Haim Stolovitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Visior Technologies Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}