Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-03-18 @ 2:22 AM
Study NCT ID:
NCT06594666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Training for Improving Intermittent Exotropia Visual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-10', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in stereoscopic vision function after 6 month', 'timeFrame': '6 months after baseline', 'description': 'Compare whether the intervention group has better stereoscopic vision function than the control group after 6 months'}, {'measure': 'changes in stereoscopic vision function after 12 month', 'timeFrame': '12 month after baseline', 'description': 'Stop the intervention group training after 6 months and observe for another 6 months to see if there will be a decrease in stereoscopic vision function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['visual training', 'visual function', 'intermittent exotropia'], 'conditions': ['Intermittent Exotropia', 'Visual Functions']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical tral is to investigate that if VR/AR visual training can improve the visual function in children with intermittent exotropia.\n\nThe main question it aims to answer is :\n\nDoes the VR/AR visual training can enhance stereoscopic vision function in children with intermittent exotropia.\n\nResearchers will compare intervention group to control group to see if VR/AR visual training could enhance stereoscopic vision function in children with intermittent exotropia.\n\nParticipants will:\n\nThe intervention group will receive 20 minutes of VR/AR visual training once a day for a period of one year.\n\nFollow up check ups at the hospital every 3 months. Keep a diary of the values of stereoscopic vision function and Newcastle Control Score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAged 6 to 14 years. Intermittent exotropia meeting all of the following criteria: Exodeviation at least 10Δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10Δby prism and alternate cover test, mean distance Newcastle Control Score (NCS)≥2 points (mean of 3 assessments during the examination).\n\nRefractive error between -5.00 D \\< spherical equivalents (SEs) ≤ -1.00 D, astigmatism ≤1.50D, anisometropia ≤1.5D, best visual acuity in each eye of 1.0.\n\nNot receiving any other form of strabismus or myopia treatment within 3 months. Willing to follow the research plan and participate in the entire research process.\n\nParticipants and guardians agree to be randomly assigned and sign an informed consent form.\n\nExclusion Criteria:\n\nVertical strabismus; Diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; Existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; Unable to cooperate with eye examination and follow-up work.'}, 'identificationModule': {'nctId': 'NCT06594666', 'briefTitle': 'Visual Training for Improving Intermittent Exotropia Visual Function', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Clinical Study on the Effectiveness and Safety of Visual Training for Improving Intermittent Exotropia Visual Function', 'orgStudyIdInfo': {'id': 'QX-2024-A-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR/AR visual training group', 'description': 'Wear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year.', 'interventionNames': ['Device: VR/AR visual training group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No intervention, simply wearing glasses for correction, followed up every 3 months for a total of 12 months.'}], 'interventions': [{'name': 'VR/AR visual training group', 'type': 'DEVICE', 'description': 'Wear glasses for correction combined with VR/AR visual training in the first 6 months, and terminate the training for follow-up observation in the last 6 months. Regular follow-up every 3 months, with a total follow-up time of 1 year.', 'armGroupLabels': ['VR/AR visual training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Xu, PhD', 'role': 'CONTACT', 'email': 'vvxuwei@163.com', 'phone': '+86-18521513008'}, {'name': 'Qiurong Lin, PhD', 'role': 'CONTACT', 'email': 'oculist_qiurong@126.com', 'phone': '+86-15216698330'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}