Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT03409094
Status:
WITHDRAWN
Last Update Posted:
2019-04-16
First Post:
2018-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dongguan Eye Study of Schoolchildren and Adolescents（DESSA）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'equipments and staff are unavailable.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-13', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of ocular fundus parameter in schoolchildren and adolescents', 'timeFrame': '3 years', 'description': 'Record the change of retinal thickness during the follow-up periods.'}], 'secondaryOutcomes': [{'measure': 'Changes of ocular biometry measurement in schoolchildren and adolescents', 'timeFrame': '3 years', 'description': 'Record the change of choroidal thickness during the follow-up periods.'}, {'measure': 'Changes of ocular anterior segment in schoolchildren and adolescents', 'timeFrame': '3 years', 'description': 'Record the change of corneal thickness during the follow-up periods.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Development']}, 'descriptionModule': {'briefSummary': 'This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Schoolchildren and adolescents ranging from 7 to 18 years old in Dongguan.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schoolchildren and adolescents aged 7 to18 years in Dongguan\n* Parents are willing to sign the informed written consent.\n\nExclusion Criteria:\n\n* Those without informed written consent or unable to obey the study procedures'}, 'identificationModule': {'nctId': 'NCT03409094', 'briefTitle': 'Dongguan Eye Study of Schoolchildren and Adolescents（DESSA）', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Study on Ocular Biometry Measurement of Schoolchildren and Adolescents in China', 'orgStudyIdInfo': {'id': '2017KYPJ119'}}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xiulan Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Director of Glaucoma Department,Director of Clinical Research Center, Director of Institution of Drug Clinical Trials', 'investigatorFullName': 'Xiulan Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}