Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:42 PM
Study NCT ID:
NCT04487795
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2020-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2020-07-23', 'studyFirstSubmitQcDate': '2020-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'crystalline lens tilt', 'timeFrame': '2020.4.30', 'description': 'magnitude and direction of crystalline lens lilt'}, {'measure': 'crystalline lens decentration', 'timeFrame': '2020.4.30', 'description': 'magnitude and direction of crystalline lens decentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['crystalline lens tilt', 'crystalline lens decentration', 'swept-source optical coherence tomography'], 'conditions': ['Crystalline Cataract', 'Lens; Anomaly']}, 'descriptionModule': {'briefSummary': '230 participants at Eye Hospital of Wenzhou Medical University during June, 2019 and August, 2019 were enrolled in this study. 230 right eyes and 88 left eyes were included for the measurement. All the measurements were performed under non-mydriatic conditions in a dim examination room using the CASIA2 swept-source AS-OCT system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers and patients with age-related cataract at Eye hospital of Wenzhou Medical University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria：\n\n* healthy volunteers and patients with age-related cataract\n\nExclusion Criteria:\n\n* aphakia or pseudophakia\n* any other ocular diseases with the exception of senile cataract\n* any history of ocular surgery\n* fixation difficulties caused by any reasons'}, 'identificationModule': {'nctId': 'NCT04487795', 'briefTitle': 'Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Age-related Changes of Crystalline Lens Tilt and Decentration: A Swept-source Optical Coherence Tomography Study', 'orgStudyIdInfo': {'id': 'SSOCT-lens tilt'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'under 18 years old'}, {'label': '18-40 years old'}, {'label': '41-60 years old'}, {'label': 'over 60 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ophthalmology and Optometry Hospital', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yune Zhao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice president of Eye Hospital of Wenzhou Medical University', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}