Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-02 @ 9:02 PM
Study NCT ID:
NCT03906994
Status:
WITHDRAWN
Last Update Posted:
2022-01-12
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Amblyopia in Adults With Interactive Video Games
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 0}}, 'statusModule': {'whyStopped': 'Original study PI left institution and the new PI elected not to proceed with the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual acuity', 'timeFrame': 'Baseline, one month', 'description': 'measured using the LogMAR (Logarithm of the Minimum Angle of Resolution) chart comprised of rows of letters to estimate visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Amblyopia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine whether interactive video game play, while wearing a patch over better-seeing eye, will improve subject reduced vision (amblyopia).', 'detailedDescription': 'The purpose of this research is to determine whether amblyopia (reduced vision in one eye) in adults can be improved using interactive video game play.\n\nStudy participation involves playing the video game Mario KartTM (provided by the study), while wearing a patch over their better-seeing eye. Participants are asked to play the game for a total of 40 hours over a one-month period.\n\nThe primary outcome measure will be LogMAR visual acuity measured 1 month after initiating game play.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>17 years old\n* Refraction within past year and wearing updated glasses or contact lenses\n* Diagnosis of strabismic, anisometropic or combined amblyopia (\\> 2 lines inter-ocular difference)\n* Stable visual acuity as defined as \\<1 LogMAR change over 2 visits 8 weeks apart, or wearing glasses for at least 16 weeks\n\nExclusion Criteria:\n\n* Monovision and unwilling to wear corrective glasses\n* Allergy to adhesive bandages\n* Women who are currently pregnant'}, 'identificationModule': {'nctId': 'NCT03906994', 'briefTitle': 'Treating Amblyopia in Adults With Interactive Video Games', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Treating Amblyopia in Adults With Interactive Video Games', 'orgStudyIdInfo': {'id': '19-000212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with Amblyopia', 'description': 'Adult amblyopia subjects will play the video game Mario Kart Wii', 'interventionNames': ['Other: Video game Mario Kart Wii']}], 'interventions': [{'name': 'Video game Mario Kart Wii', 'type': 'OTHER', 'description': 'Subjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior', 'armGroupLabels': ['Subjects with Amblyopia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erick Bothun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erick D. Bothun', 'investigatorAffiliation': 'Mayo Clinic'}}}}