Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-13 @ 2:41 PM
Study NCT ID:
NCT06849895
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-27
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-World Study of Myopia Prevention and Control in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-23', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-23', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Myopia incidence', 'timeFrame': 'Assessed at 12 months, 24 months, and 36 months post-baseline.', 'description': 'Myopia incidence'}, {'measure': 'Myopia progression', 'timeFrame': 'Assessed at 12 months, 24 months, and 36 months post-baseline.', 'description': 'Myopia progression in myopic participants'}], 'secondaryOutcomes': [{'measure': 'Myopic shift', 'timeFrame': 'Assessed at 12 months, 24 months, and 36 months post-baseline.', 'description': 'Change of spherical equivalence and axial length'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia', 'premyopia', 'outdoor activities', 'myopia prevention', 'myopia control', 'children', 'compliance', 'defocus optical lenses'], 'conditions': ['Myopia', 'Refractive Errors', 'Children', 'Cohort']}, 'descriptionModule': {'briefSummary': 'This prospective, school-based cohort study aims to enroll approximately 15,000 primary school students from multiple districts in Shanghai, China and to observe the outcomes on myopia prevention and control in children with varying refractive status (including sufficient hyperopia reserve, relative insufficiency in hyperopia reserve, pre-myopia and myopia) who are exposed to a school-based categorized and integrated interventions strategy in real-world settings.\n\nThe primary objective of this study is to observe the change in the incidence and prevalence of myopia as well as the the progression of myopia among primary school students population under a school-based interventions, including increasing outdoor activities and wearing special designed optical lenses. The second objective is to identify factors influencing the outcomes and assess the compliance of different intervention methods. Additionally, a cost-effectiveness analysis will be conducted to assess the implementation process, providing technical solutions and operational models for wider application.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All students in the enrolled schools can participate in the project and receive tiered interventions after obtaining informed consent from their guardians. After professional examination, students with conditions such as strabismus, amblyopia, other significant ocular abnormalities, systemic diseases, or those currently undergoing other myopia interventions will generally not be fitted with specially designed myopia control spectacles.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All students from the enrolled schools;\n2. Participants must be able to cooperate with and complete all required ophthalmic examinations;\n3. Written informed consent must be obtained from their parents or legal guardians.\n\nExclusion Criteria:\n\n1. Ocular abnormalities (e.g., strabismus, amblyopia, or other significant eye diseases);\n2. Systemic diseases that may affect ocular health;\n3. Current participation in other myopia intervention programs.'}, 'identificationModule': {'nctId': 'NCT06849895', 'briefTitle': 'Real-World Study of Myopia Prevention and Control in Children', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Real-World Study of Myopia Prevention and Control in Children: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'SIGCMIPCA-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sufficient hyperopia reserve', 'description': 'Cycloplegic spherical equivalence is higher than the recommended values and falls within the normal range for the corresponding age group.'}, {'label': 'Relative insufficiency in hyperopia reserve', 'description': 'Cycloplegic spherical equivalence is greater than +0.75 diopters but below the recommended value for the corresponding age group.'}, {'label': 'Premyopia', 'description': '-0.50 diopters \\< cycloplegic spherical equivalence ≤ +0.75 diopters'}, {'label': 'Myopia', 'description': 'Cycloplegic spherical equivalence ≤ -0.50 diopters'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200336', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Eye Disease Prevention and Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiangui He, PhD', 'role': 'CONTACT', 'email': 'xianhezi@163.com', 'phone': '+86 021-62717733'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}