Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT06585657
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Visual Perception Training for Prevention and Control of Premyopia
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-09', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in axial length after 1 year', 'timeFrame': '1 year after the baseline', 'description': 'the difference in the changes of axial length between the intervention group and the control group'}], 'secondaryOutcomes': [{'measure': 'changes in cycloplegic spherical equivalent after 1year', 'timeFrame': '1 year after the baseline', 'description': 'the difference in the changes of cyclopegic spherical equivalent between the intervention group and the control group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brain visual perception training', 'premyopia'], 'conditions': ['Visual Function', 'Myopia Progressing']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate whether brain visual perception training can effectively prevent myopia in children with pre myopia. It will also learn about the safety of brain visual perception training.\n\nThe main questions it aims to answer are: Does brain visual perception training slow down the growth of axial length? What medical issues may participants encounter when using the brain visual perception training system? Researchers will compare participants who receive brain visual perception training with a control group to see if the training group can delay the onset of pre myopia in children Participants will: The training group will receive 20 minutes of brain visual perception training once a day for a period of one year. Follow up check ups at the hospital every 3 months. Keep a diary of the values of axial length and refractive diopter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren aged 6-10 years with premyopia, defined as a cycloplegic spherical equivalent refraction (SER) of the more myopic eye in the range of -0.50 to 0.75 (inclusive) diopters (D) and having at least 1parent with an SER in either eye of -3.00D or less.\n\nExclusion Criteria:\n\nChildren have astigmatism of 1.50D or more, anisometropia of 1.50 D or more, strabismus and other ocular abnormalities, any systemic diseases, or a history of any myopia interventions.'}, 'identificationModule': {'nctId': 'NCT06585657', 'briefTitle': 'Brain Visual Perception Training for Prevention and Control of Premyopia', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Clinical Study on Brain Visual Perception Training for Prevention and Control of Myopia in Children with Premyopia', 'orgStudyIdInfo': {'id': 'QX-2024-A-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'brain visual perception training group', 'description': 'Conduct brain visual perception training through a visual training system to improve binocular visual balance. Train 2 projects per day, each lasting 10 minutes.', 'interventionNames': ['Device: brain visual perception training group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'no intervention'}], 'interventions': [{'name': 'brain visual perception training group', 'type': 'DEVICE', 'description': 'Conduct brain visual perception training through a visual training system to improve binocular visual balance. Train 2 projects per day, each lasting 10 minutes.', 'armGroupLabels': ['brain visual perception training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wei Xu, PhD', 'role': 'CONTACT', 'email': 'vvxuwei@163.com', 'phone': '+8618521513008'}, {'name': 'Haidong Zou, PhD', 'role': 'CONTACT', 'email': 'zouhaidong@sjtu.edu.cn', 'phone': '+8613311986528'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}