Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03608150
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Luminopia One Amblyopia Vision Improvement Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'endri@luminopia.com', 'phone': '9788067080', 'title': 'VP of Clinical Development', 'organization': 'Luminopia, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'We evaluated the therapeutic alongside continued refractive correction alone over 12 weeks and we did not compare with patching or atropine penalization, so we do not know the relative safety and efficacy of the therapeutic versus patching or atropine, nor the durability of benefit from the therapeutic. The duration of our study was limited to 12 weeks, which may have biased the results toward superiority of one treatment over the other depending on the time course of responses.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected throughout the study at each follow-up phone call or visit.', 'description': 'Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.', 'eventGroups': [{'id': 'EG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 58, 'otherNumAffected': 13, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 9, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'New heterotropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening best-corrected visual acuity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.', 'unitOfMeasure': 'Lines of visual acuity improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Best-Corrected Visual Acuity of Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.', 'unitOfMeasure': 'Lines of visual acuity improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'Mean adherence with the therapeutic in treatment group.', 'unitOfMeasure': 'percentage of prescribed therapy', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.', 'unitOfMeasure': 'Lines of visual acuity improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '1.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.', 'unitOfMeasure': 'Lines of visual acuity improvement', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stereoacuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Mean stereoacuity improvement from baseline after 12 weeks.', 'unitOfMeasure': 'Change in log arc seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.\n\nLuminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.\n\nRefractive Correction: Standard of care refractive correction (ex. spectacles)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '6.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Amblyopia Treatment', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-08', 'size': 537545, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-12T19:52', 'hasProtocol': True}, {'date': '2020-04-09', 'size': 10143591, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-02T12:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-24', 'studyFirstSubmitDate': '2018-07-12', 'resultsFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-24', 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'timeFrame': '12 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.'}, {'measure': 'Best-Corrected Visual Acuity of Fellow Eye', 'timeFrame': '12 weeks', 'description': 'Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.'}], 'secondaryOutcomes': [{'measure': 'Adherence', 'timeFrame': '12 weeks', 'description': 'Mean adherence with the therapeutic in treatment group.'}, {'measure': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'timeFrame': '4 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.'}, {'measure': 'Best-Corrected Visual Acuity of Amblyopic Eye', 'timeFrame': '8 weeks', 'description': 'Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.'}, {'measure': 'Stereoacuity', 'timeFrame': '12 weeks', 'description': 'Mean stereoacuity improvement from baseline after 12 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amblyopia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.', 'detailedDescription': 'The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4 to 7 years at the time of consent.\n* Amblyopia associated with anisometropia and/or mild strabismus.\n* Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.\n* Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.\n* Fellow eye BCVA 20/32 or better.\n* Interocular difference ≥ 3 logMAR lines.\n* Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.\n\nExclusion Criteria:\n\n* Atropine treatment in the past 2 weeks.\n* Prior amblyopia treatment (other than refractive correction) for \\> 12 months in total.\n* High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.\n* History of low adherence with amblyopia treatment or light-induced seizures.'}, 'identificationModule': {'nctId': 'NCT03608150', 'briefTitle': 'Luminopia One Amblyopia Vision Improvement Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luminopia'}, 'officialTitle': 'Luminopia One Amblyopia Vision Improvement Study', 'orgStudyIdInfo': {'id': 'C-AM-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Therapeutic Group', 'description': 'Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.', 'interventionNames': ['Device: Luminopia One']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.', 'interventionNames': ['Device: Refractive Correction']}], 'interventions': [{'name': 'Luminopia One', 'type': 'DEVICE', 'description': 'Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.', 'armGroupLabels': ['Therapeutic Group']}, {'name': 'Refractive Correction', 'type': 'DEVICE', 'description': 'Standard of care refractive correction (ex. spectacles)', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Jules Stein Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Family Focus Eye Care', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Physicians of Central Florida', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU School of Optometry', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '21703', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Kids Eye Care of Maryland', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Specialized Pediatric Eye Care', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}, {'zip': '48124', 'city': 'Dearborn', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Eye Care of Michigan", 'geoPoint': {'lat': 42.32226, 'lon': -83.17631}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Saint Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OSU College of Optometry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '16501', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pediatric Ophthalmology of Erie', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Conestoga Eye', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital Of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18966', 'city': 'Southampton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Tri-County Eye Physicians', 'geoPoint': {'lat': 40.17428, 'lon': -75.04378}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital (BCM)", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77381', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain Eye Care', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Pediatric Eye Center', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'overallOfficials': [{'name': 'Scott Xiao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Luminopia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luminopia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}