Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT04763694
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '12 months', 'description': 'Change in axial length over the duration of the study'}, {'measure': 'Refractive error', 'timeFrame': '12 months', 'description': 'Change in refractive error over the duration of the study'}, {'measure': 'Accommodation', 'timeFrame': '12 months', 'description': 'Accommodation at various distances during the study'}], 'secondaryOutcomes': [{'measure': 'Phoria', 'timeFrame': '12 months', 'description': 'The amount of horizontal phoria (in prism diopter) at near while the subjects wore multifocal soft contact lenses, measured using Modified Thorington'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Myopia', 'Accommodation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.\n\nThe study objectives are to:\n\n1. Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.\n2. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 8-17 years\n* Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D\n* Monocular BCVA 20/25 or better\n* No previous CL experience required\n\nExclusion Criteria:\n\n* History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.'}, 'identificationModule': {'nctId': 'NCT04763694', 'briefTitle': 'Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York College of Optometry'}, 'officialTitle': 'Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control', 'orgStudyIdInfo': {'id': 'IRBNET ID 1325316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment arm', 'description': 'Subjects wore multifocal soft contact lenses for 12 months.', 'interventionNames': ['Device: Multifocal soft contact lenses']}], 'interventions': [{'name': 'Multifocal soft contact lenses', 'type': 'DEVICE', 'description': 'Myopic subjects wore multifocal soft contact lenses for 12 months', 'armGroupLabels': ['Treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Stewart Bloomfield, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'State University of New York College of Optometry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York College of Optometry', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Clinical Professor', 'investigatorFullName': 'Xiaoying Zhu', 'investigatorAffiliation': 'State University of New York College of Optometry'}}}}