Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT04346251
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Correlation Between Refraction and Biometric Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2020-04-10', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'refractive error in diopters and biometric Parameters', 'timeFrame': 'up to 1 year', 'description': 'Multiple regression analysis will be performed to evaluate the correlations between SER and the other biometric parameters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractive Errors']}, 'descriptionModule': {'briefSummary': 'To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.', 'detailedDescription': 'In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Schoolchildren aged 6 to 15 years will be included in this cross-sectional study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schoolchildren aged from 6 to 15 years\n\nExclusion Criteria:\n\n* with previous histories of cataracts, keratitis, strabismus, or other visual impairments\n* with history of previous eye surgery\n* with unreliable auto-refraction values\n* unwilling to participate'}, 'identificationModule': {'nctId': 'NCT04346251', 'briefTitle': 'Correlation Between Refraction and Biometric Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Correlation Analysis of Refraction and Biometric Parameters in Chinese Schoolchildren', 'orgStudyIdInfo': {'id': 'CCPMOH2017-China-1101'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruiyang Li, M.D.', 'role': 'CONTACT', 'email': 'li_ruiyang@qq.com', 'phone': '13602477886'}], 'facility': 'Zhognshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Haotian Lin, Ph.D', 'role': 'CONTACT', 'email': 'gddlht@aliyun.com', 'phone': '+86-020-87330274'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}