Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2026-04-02 @ 4:21 AM
Study NCT ID:
NCT02246556
Status:
TERMINATED
Last Update Posted:
2017-05-03
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}, {'id': 'D015858', 'term': 'Anisometropia'}, {'id': 'D013285', 'term': 'Strabismus'}], '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'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Recruitment inadequate and investigators leaving the study institution for new positions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual acuity', 'timeFrame': '3 weeks, 6 weeks, and 6 months'}], 'secondaryOutcomes': [{'measure': 'Change in stereopsis', 'timeFrame': '3 weeks, 6 weeks, and 6 months'}, {'measure': 'Quality of life', 'timeFrame': '3 weeks, 6 weeks, and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Amblyopia', 'Dichoptic', 'Virtual reality', 'Stereopsis', 'Stereo vision', 'Visual acuity', 'Binocular'], 'conditions': ['Amblyopia', 'Anisometropia', 'Strabismus']}, 'descriptionModule': {'briefSummary': 'This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Interpupillary distance of 60-66 mm\n* Age 15-40\n* Anisometropic amblyopia or strabismic amblyopia\n* Best corrected visual acuity of 20/30 or worse in the amblyopic eye\n* No prior therapeutic use of the software\n* No other ongoing therapies including patching or recent eye muscle surgery\n* No vested interest in the product\n* Ability attend visits and complete the training session, and to stop the intervention after the specified intervention period\n\nExclusion Criteria:\n\n* Stimulus-deprivation amblyopia.\n* Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).\n* Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).\n* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).\n* Patients diagnosed with Photosensitive Epilepsy.\n* Inability to comply with the follow-up visits required.\n* History of pathologic nystagmus (congenital or sensory).'}, 'identificationModule': {'nctId': 'NCT02246556', 'briefTitle': 'Dichoptic Virtual Reality Therapy for Amblyopia in Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Dichoptic Virtual Reality Therapy for Amblyopia in Adults', 'orgStudyIdInfo': {'id': '14-14212'}, 'secondaryIdInfos': [{'id': '093955', 'type': 'OTHER', 'domain': 'UCSF'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patching therapy', 'description': 'Patching treatment followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.', 'interventionNames': ['Other: Patching therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dioptic (non-dichoptic) therapy', 'description': 'Dioptic (non-dichoptic) therapy followed by crossover to dichoptic virtual reality video game treatment arm using Diplopia (TM) software developed for the Oculus Rift (R) game system.', 'interventionNames': ['Device: Dioptic (non-dichoptic) therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Dichoptic therapy', 'description': 'Dichoptic virtual reality video game treatment using Diplopia (TM) software developed for the Oculus Rift (R) game system.', 'interventionNames': ['Device: Dichoptic therapy']}], 'interventions': [{'name': 'Dichoptic therapy', 'type': 'DEVICE', 'description': 'Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system', 'armGroupLabels': ['Dichoptic therapy']}, {'name': 'Patching therapy', 'type': 'OTHER', 'description': 'Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software', 'armGroupLabels': ['Patching therapy']}, {'name': 'Dioptic (non-dichoptic) therapy', 'type': 'DEVICE', 'description': 'Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software', 'armGroupLabels': ['Dioptic (non-dichoptic) therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Neuro-ophthalmology', 'investigatorFullName': 'Marc Levin', 'investigatorAffiliation': 'University of California, San Francisco'}}}}