Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-28 @ 11:17 AM
Study NCT ID:
NCT05770661
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Axial Length Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-03-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of visual acuity outcomes obtained by VA charts with different optotypes among children', 'timeFrame': 'Baseline vision testing at enrollment (single study visit)', 'description': 'This outcome measure evaluates differences in uncorrected visual acuity (UCVA) results obtained using HOTV and Tumbling E logMAR charts among children aged 3-15 years.'}], 'primaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '2023-2026', 'description': 'Axial length in millimeter was examined by IOL Master'}], 'secondaryOutcomes': [{'measure': 'Axial length elongation', 'timeFrame': '2023-2026', 'description': 'The elongation in millimeter was the difference between two annual visits.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Axial Length', 'Myopia', 'Child Development']}, 'descriptionModule': {'briefSummary': 'The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.\n\n30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Students aged from 3 to 18 years old were recruited from schools to enroll the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 3 to 18 years\n* Have been lived in the research areas for at least one year, and will not move to other places in the following two years\n* Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate\n\nExclusion Criteria:\n\n* Mental diseases, unable to cooperate to complete the eye assessment\n* Ophthalmic diseases, inability to cooperate to complete the inspection'}, 'identificationModule': {'nctId': 'NCT05770661', 'acronym': 'CALS', 'briefTitle': 'China Axial Length Study', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'Axial Length Study of Children and Adolescents in Ten Provinces of China', 'orgStudyIdInfo': {'id': 'NO.CALS20220101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myopes', 'description': 'To collect the ocular data among myopic children.'}, {'label': 'Non-myopes', 'description': 'To collect the ocular data among non-myopic children.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xun Xu, MD', 'role': 'CONTACT', 'email': 'drxuxun@tom.com', 'phone': '86-13386259538'}], 'facility': 'Shanghai Eye Disease Prevention & Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangui He', 'role': 'CONTACT', 'email': 'xianhezi@163.com', 'phone': '8602153555032'}], 'facility': 'Shanghai Eye Disease Prevention and Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xun Xu, MD', 'role': 'CONTACT', 'email': 'drxuxun@sjtu.edu.cn', 'phone': '021-53555032', 'phoneExt': '86'}, {'name': 'Xiangui He, PhD', 'role': 'CONTACT', 'email': 'xianhezi@163.com', 'phone': '15000755422', 'phoneExt': '86'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': "Sichuan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': "People's Hospital of Ningxia Hui Autonomous Region", 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Guangxi Traditional Chinese Medical University', 'class': 'UNKNOWN'}, {'name': 'Affiliated Hospital of Inner Mongolia Minzu University', 'class': 'UNKNOWN'}, {'name': 'Xinjiang Hospital of Traditional Chinese Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Jiannan Huang', 'investigatorAffiliation': 'Shanghai Eye Disease Prevention and Treatment Center'}}}}