Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-28 @ 6:16 AM
Study NCT ID:
NCT04360161
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "area of Schlemm's canal and trabecular meshwork", 'timeFrame': 'up to 6 months', 'description': "The area of Schlemm's canal and trabecular meshwork was manually measured and the relationship between the parameters and age was analyzed."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Schlemm's Canal Occlusion"]}, 'descriptionModule': {'briefSummary': "The aim of this study is to quantify and observe the morphology of trabecular meshwork (TM), Schlemm's canal (SC), ciliary body and crystalline lens before and after cycloplegia in patients with different ages using swept-source optical coherence tomography."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy patients who can cooperated with the swept-source OCT measurements\n\nExclusion Criteria:\n\n* history of ocular disease\n* presence of central nervous system or systemic disease'}, 'identificationModule': {'nctId': 'NCT04360161', 'briefTitle': "Observing the Morphology of Schlemm's Canal and Crystalline Lens in Different Age", 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': "Morphology of Schlemm's Canal and Crystalline Lens in Different Age: a Swept-source Optical Coherence Tomography Study", 'orgStudyIdInfo': {'id': 'TM/SC/Lens-LZL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy participants', 'description': 'Swept-source optical coherence tomography A device testing TM/SC and Lens morphology', 'interventionNames': ['Device: swept-source optical coherence tomography']}], 'interventions': [{'name': 'swept-source optical coherence tomography', 'type': 'DEVICE', 'description': 'Aswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of \\<10 μm.', 'armGroupLabels': ['Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hospital of WMU', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Yune Zhao', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eye Hospital of Wenzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cataract Department', 'investigatorFullName': 'Yune Zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}