Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 11:43 AM
Study NCT ID:
NCT04340635
Status:
UNKNOWN
Last Update Posted:
2020-04-09
First Post:
2020-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Ocular Biological Parameters Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2020-03-29', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'axial length (AL)', 'timeFrame': '1 hour', 'description': 'Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)'}, {'measure': 'anterior chamber depth (ACD)', 'timeFrame': '1 hour', 'description': 'Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)'}, {'measure': 'keratometric power (K)', 'timeFrame': '1 hour', 'description': 'Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)'}, {'measure': 'corneal astigmatism (CA)', 'timeFrame': '1 hour', 'description': 'Measured using the partial coherence laser interferometry (IOLMaster, Carl Zeiss Meditec, Germany)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Corneal astigmatism', 'axial length (AL), anterior chamber depth (ACD)', 'partial coherence interferometry'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '34551738', 'type': 'DERIVED', 'citation': 'Qian Z, Xie X, Yang J, Ye H, Wang Z, Chen J, Liu H, Liang J, Jiang L, Zheng C, Chen X. Detection of shallow anterior chamber depth from two-dimensional anterior segment photographs using deep learning. BMC Ophthalmol. 2021 Sep 22;21(1):341. doi: 10.1186/s12886-021-02104-0.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multi-center study, which collects data from multiple regions to obtain the general biological characteristics of the Chinese population. The formula for calculating the artificial lens power based on foreign populations is effectively modified based on the Chinese population.', 'detailedDescription': '①Relevant domestic studies on the biological characteristics of the eye are mainly limited to a certain city and region. Most of the studies that represent the biological characteristics of the general population in China and the differences in biological parameters at home and abroad are in the research process, or Semi-finished products.\n\n②The investigators found in clinical observation that the eyeball biological data of the Chinese population may not be consistent with the foreign population.\n\n③ This study is the first study of human eye biological parameters based on different regions of large-scale populations in China, which is of great significance for understanding the human eye structure in different regions of China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Select elderly cataract patients from different regions of China (at least one representative city in each of east, south, west, north, and central China) who were treated in Aier Eye Hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged over 50 years\n\nExclusion Criteria:\n\n* history of refractive surgery,\n* corneal diseases\n* ocular inflammation\n* trauma'}, 'identificationModule': {'nctId': 'NCT04340635', 'briefTitle': 'Multi-center Ocular Biological Parameters Study', 'organization': {'class': 'OTHER', 'fullName': 'Aier School of Ophthalmology, Central South University'}, 'officialTitle': 'Analysis of Eye Bioparametric Data of Chinese Population Based on Big Data', 'orgStudyIdInfo': {'id': 'SHIRB2018020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multi-center data collection', 'description': 'Without intervention'}], 'interventions': [{'type': 'OTHER', 'description': 'Without intervention', 'armGroupLabels': ['Multi-center data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xu chen', 'role': 'CONTACT', 'email': 'Francois.chenxu@gmail.com', 'phone': '+8613601762646'}, {'name': 'hui Liu', 'role': 'CONTACT', 'email': '1009254042@qq.com', 'phone': '18570638843'}], 'facility': 'Shanghai Aier Eye Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'xu chen', 'role': 'CONTACT', 'email': 'Francois.chenxu@gmail.com', 'phone': '13601762646'}, {'name': 'hui liu', 'role': 'CONTACT', 'email': '1009254042@qq.com', 'phone': '18570638843'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aier School of Ophthalmology, Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}