Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT04691427
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Virtual Reality Vision Therapy - VERVE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-09', 'releaseDate': '2025-03-21'}], 'estimatedResultsFirstSubmitDate': '2025-03-21'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Examiner (Outcomes Assessor) will be masked by pooling participants from another study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Fusional Vergence', 'timeFrame': 'up to 4 weeks post-therapy', 'description': 'Normal range is \\>15 Prism Diopters'}, {'measure': 'Near Point of Convergence', 'timeFrame': 'up to 4 weeks post-therapy', 'description': 'Normal range is \\< 6 cm'}], 'secondaryOutcomes': [{'measure': 'Convergence Insufficiency Symptom Survey (CISS)', 'timeFrame': 'up to 4 weeks post-therapy', 'description': 'Normal range is \\< 21 for adults and \\< 16 for pediatrics'}, {'measure': 'Vision Quality of Life with Time Survey (VisQuaL-T)', 'timeFrame': 'up to 4 weeks post-therapy', 'description': 'Normal range is \\> 2.5'}, {'measure': 'Core Elements of Gaming Experience Questionnaire', 'timeFrame': 'up to 4 weeks post-therapy', 'description': 'User experience rating'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Convergence Insufficiency']}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 9 years and older\n* CISS score ≥ 16\n* Best-corrected distance visual acuity of 20/25 or better in each eye\n* Random dot stereopsis appreciation of 500 seconds of arc or better\n* Parent or subject understands the protocol and is willing to enroll in the study\n\nExclusion Criteria:\n\n* Constant strabismus at distance or near\n* Vertical heterophoria ≥ 2 ∆ at distance or near\n* ≥ 2 line interocular difference in best-corrected visual acuity\n* Near point of accommodation \\> 20 cm in either eye as measured by push-up method\n* Manifest or latent nystagmus\n* Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain\n* Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease\n* Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)\n* Inability to comprehend and/or perform any study-related test or procedure'}, 'identificationModule': {'nctId': 'NCT04691427', 'acronym': 'VRVT - VERVE', 'briefTitle': 'Effectiveness of Virtual Reality Vision Therapy - VERVE', 'organization': {'class': 'INDUSTRY', 'fullName': 'OculoMotor Technologies'}, 'officialTitle': 'Effectiveness of Vision Therapy in a Virtual Reality Headset', 'orgStudyIdInfo': {'id': 'OMT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Virtual Reality-Based Vision Therapy', 'description': 'Virtual reality vision therapy where participants will be playing a custom-designed video game to act as a therapeutic intervention on a consumer-available virtual reality headset.', 'interventionNames': ['Device: Virtual Eye Rotation Vision Exercises (VERVE)']}], 'interventions': [{'name': 'Virtual Eye Rotation Vision Exercises (VERVE)', 'type': 'DEVICE', 'description': 'A video game designed with elements of vision therapy will be delivered to participants utilizing consumer-available virtual reality headsets (VIVE Pro Eye).', 'armGroupLabels': ['Active Virtual Reality-Based Vision Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chang Yaramothu, PhD', 'role': 'CONTACT', 'email': 'cto@omtvr.com'}], 'facility': 'OculoMotor Technologies', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'The Eye Institute at Salus University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Chang Yaramothu, PhD', 'role': 'CONTACT', 'email': 'cto@omtvr.com', 'phone': '9735585456'}], 'overallOfficials': [{'name': 'Chang Yaramothu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'OculoMotor Technologies'}, {'name': 'Tara L Alvarez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OculoMotor Technologies'}, {'name': 'Mitchell M Scheiman, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OculoMotor Technologies'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OculoMotor Technologies', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'New Jersey Institute of Technology', 'class': 'OTHER'}, {'name': 'Salus University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-21', 'type': 'RELEASE'}, {'date': '2025-04-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'OculoMotor Technologies'}}}}