Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:57 PM
Study NCT ID:
NCT04992403
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ocular Biometrics in a French Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-27', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with Distribution of ocular biometrics', 'timeFrame': '1 day', 'description': 'Distribution of ocular biometrics and their association with age and gender'}], 'secondaryOutcomes': [{'measure': 'number of patients with Prevalence of high myopia', 'timeFrame': '1 day', 'description': 'Prevalence of high myopia'}, {'measure': 'rate of inhomogeneous eyes', 'timeFrame': '1 day', 'description': 'rate of inhomogeneous eyes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biometry', 'Axial length', 'Cataract', 'Gender', 'High myopia'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The investigators aimed to study ocular biometrics parameters and their association with age, gender and the prevalence of high myopia in a population of cataract surgery candidates in the South of France. The investigators also aimed to define proportion of an "usual eye" and know the rate of inhomogeneous eyes in our population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent ocular biometrics before cataract surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* aged 40 years\n* olderpatients who underwent ocular biometrics before cataract surgery\n\nExclusion criteria: incomplete examination\n\n* previous cataract surgery\n* age \\< 40 years'}, 'identificationModule': {'nctId': 'NCT04992403', 'briefTitle': 'Ocular Biometrics in a French Population', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Ocular Biometric Measurements in Cataract Surgery Candidates in The South of France : a Multicenter Cross Sectional Study', 'orgStudyIdInfo': {'id': 'RECHMPL21_0458'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Vincent DAIEN, MD, PhD, HDR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}