Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT05637827
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-26', 'studyFirstSubmitDate': '2022-11-26', 'studyFirstSubmitQcDate': '2022-11-26', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of refractive error', 'timeFrame': 'Every 6 months for a period 3 years', 'description': 'The changes of refractive error between visit time in every 6 months'}, {'measure': 'The changes of axial length', 'timeFrame': 'Every 6 months for a period 3 years', 'description': 'The changes of axial length between visit time in every 6 months.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia; Refractive Error']}, 'referencesModule': {'references': [{'pmid': '26875007', 'type': 'RESULT', 'citation': 'Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.'}, {'pmid': '27898443', 'type': 'RESULT', 'citation': 'Rose KA, French AN, Morgan IG. Environmental Factors and Myopia: Paradoxes and Prospects for Prevention. Asia Pac J Ophthalmol (Phila). 2016 Nov/Dec;5(6):403-410. doi: 10.1097/APO.0000000000000233.'}, {'pmid': '12535999', 'type': 'RESULT', 'citation': 'Seidemann A, Schaeffel F. An evaluation of the lag of accommodation using photorefraction. Vision Res. 2003 Feb;43(4):419-30. doi: 10.1016/s0042-6989(02)00571-0.'}]}, 'descriptionModule': {'briefSummary': 'There was a prospective cohort observational study. Forty hyperopic children, 40 myopic children and 120 emmetropia children were randomly selected from grade 1 to grade 3, and were followed up every six months for 3 years. All patients received cycloplegic refraction examination, ocular biological test, binocular visual function test and a questionnaire related to daily eye habits. A multi-level and multi-dimensional data analysis model was constructed to explore the possible factors affecting the occurrence and development of myopia in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy children with hyperopia, emmetropia and myopia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* students in grades 1-3\n* Can cooperate with the examination of students\n\nExclusion Criteria:\n\n* Obvious strabismus and amblyopia\n* Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases\n* History of ocular surgery'}, 'identificationModule': {'nctId': 'NCT05637827', 'briefTitle': 'The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Eye Hospital'}, 'officialTitle': 'The Initiating Factors of Myopia Among Primary and Secondary School Students in Tianjin', 'orgStudyIdInfo': {'id': 'Tianjin children myopia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with hyperopia', 'description': 'The refractive error and axial length of eye were observed', 'interventionNames': ['Other: No intervention']}, {'label': 'children with emmetropia', 'description': 'The refractive error and axial length of eye were observed', 'interventionNames': ['Other: No intervention']}, {'label': 'children with myopia', 'description': 'The refractive error and axial length of eye were observed', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'There was no intervention in each group, and only the natural development was observed', 'armGroupLabels': ['children with emmetropia', 'children with hyperopia', 'children with myopia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yan wang, director', 'role': 'CONTACT', 'email': 'wangyan7143@vip.sina.com', 'phone': '+86-22-27305083'}], 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'yan wang', 'role': 'CONTACT', 'email': 'wangyan7143@vip.sina.com', 'phone': '+86-22-27305083'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}