Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-18 @ 2:16 PM
Study NCT ID:
NCT03681366
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myopia Control Using Optimized Optical Defocus RCTs
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double masked design:\n\nThe investigator(s) who were responsible for refracting and performing relevant ocular data measurement were masked from the grouping of the subjects.\n\nThe unmasked investigator(s) were responsible for group allocation, spectacle-dispensing work, measuring lens visual performance, record keeping, data entry and compliance checking. Data input was carefully checked by the unmasked investigator and the other researchers independently.\n\nThe children and their parents were also masked to group allocation until the data analysis was completed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cycloplegic Refraction Change in SER', 'timeFrame': '12 months', 'description': 'Change in cycloplegic autorefraction in spherical equivalent (SER)'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '12 months', 'description': 'Axial length (mm) was measured after cycloplegia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['myopia', 'Myopic Defocus', 'contact lens', 'myopia control'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.', 'detailedDescription': 'The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.\n\nThe Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.\n\nThe efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age at enrolment: 8-13 year; Hong Kong Chinese\n* Spherical equivalent refractions (SER): -1.00 to -5.00D\n* Astigmatism: -1.00D or less\n* Anisometropia: 1.25D or less\n* Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better\n* Contact lens corrected monocular VA: 0.1 logMAR or better\n* Normal binocular function\n* Willingness to wear contact lenses regularly\n* Parents' understanding and acceptance of random allocation of grouping and masking\n\nExclusion Criteria:\n\n* Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc.\n* Strabismus or decompensated phoria (checked by cover test at far and near in screening)\n* Known contraindications for contact lens wear\n* Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development"}, 'identificationModule': {'nctId': 'NCT03681366', 'briefTitle': 'Myopia Control Using Optimized Optical Defocus RCTs', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial', 'orgStudyIdInfo': {'id': 'HSEARS20180711001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Single vision soft contact lens', 'description': 'single vision, spherical soft contact lens'}, {'type': 'EXPERIMENTAL', 'label': 'DISC3.5 Plus lens', 'description': 'A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.', 'interventionNames': ['Device: DISC3.5 plus']}], 'interventions': [{'name': 'DISC3.5 plus', 'type': 'DEVICE', 'description': 'The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.', 'armGroupLabels': ['DISC3.5 Plus lens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'The Centre of Myopia Ressearch, School of Optometry, The Hong Kong PolyU', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Carly SY Lam, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Optometry, The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Carly Lam', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}