Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-26 @ 5:26 AM
Study NCT ID:
NCT04261868
Status:
UNKNOWN
Last Update Posted:
2020-02-10
First Post:
2020-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Game Playing in Amblyopia Therapy
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'baseline and 6 months after training', 'description': 'Change from baseline BCVA at 6 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'Background: "Amblyopia is a neurodevelopmental disorder in both monocular and binocular functions and it extends even beyond the primary visual integration centers", therefore, amblyopia is not a "lazy eye" but it is a "lazy brain".\n\nPurpose: The investigators aimed to compare the visual outcome of occlusion therapy with virtual reality game playing as a new therapy on amblyopic children.\n\nMethods: This RCT was performed on 50 children with unilateral amblyopia ,4 to 10 years old. They were randomly divided to case and control (each= 25) groups. case group were trained binocularly using the virtual reality games through head set for one hour a day, 5 days in a week for 4 to 6 weeks. Controls occluded their non- amblyopic eyes, 2, 4 and 6 hours for mild (0.2 to 0.3 LogMAR), moderate (0.3 to 0.6 LogMAR) and severe (BCVA \\< 0.6 LogMAR) amblyopia, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- The best corrected visual acuity worse than 0.3 LogMAR\n\nExclusion Criteria:\n\n* Patients with abnormal fixation\n* Patients with neurological problems\n* Patients with any types of ocular pathologies'}, 'identificationModule': {'nctId': 'NCT04261868', 'briefTitle': 'Virtual Reality Game Playing in Amblyopia Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Virtual Reality Game Playing in Amblyopia Therapy', 'orgStudyIdInfo': {'id': 'IR.SBMU.ORC.REC.1398.024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'Dichoptic playing games with fine stimulation will present to the amblyopic eye.', 'interventionNames': ['Device: Virtual Reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patching', 'description': 'Non- amblyopic eye will be recommended to patch.', 'interventionNames': ['Other: Patching']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'otherNames': ['No additional intervention'], 'description': 'New treatment for amblyopia therapy using playing games', 'armGroupLabels': ['Virtual Reality']}, {'name': 'Patching', 'type': 'OTHER', 'description': 'Patching', 'armGroupLabels': ['Patching']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hamideh Sabbaghi, PhD', 'role': 'CONTACT', 'email': 'sabbaghi.opt@gmail.com', 'phone': '989120285930'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamideh Sabbaghi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hamideh Sabbaghi', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}