Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03538002
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2018-05-24', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cycloplegic refraction', 'timeFrame': '2 years', 'description': 'Refraction done under cycloplegia'}], 'secondaryOutcomes': [{'measure': 'Axial length', 'timeFrame': '2 years', 'description': 'Length of eyeball that is directly related to myopia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blue light filtering spectacle lens'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if the blue-light filtering spectacle lenses promote myopia progression in schoolchildren.', 'detailedDescription': 'The effect of blue light on ocular health has been studied extensively. Shorter wavelength such as blue light could cause damage to the retina. The damage was more evident in the ageing eye. Since the tablets and mobile with blue LED backlight display are widely used, thus blue-light filtering spectacle lenses are now available in the market. However, whether this kind of lenses could affect the eye growth in schoolchildren is unknown. This study is then designed to investigate if the blue-light filtering spectacle lenses affect myopia progression in Hong Kong Chinese schoolchildren. The schoolchildren will be randomly allocated to either blue-light filtering spectacle lens group (treated) or conventional spectacle lens group (control). Their axial length and refraction will be monitored every 6 months for 2 years. The changes between two group will then be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Refraction: myopia of -1.00 dioptres (D) to -5.00D\n* Astigmatism: equal or less than -1.50D\n* Anisometropia: equal or less than 1.00D\n* Best corrected monocular visual acuity: 0.0 LogMAR or better after full correction\n* Parents' understanding and acceptance of random allocation of grouping\n\nExclusion Criteria:\n\n* any ocular and systemic abnormalities might affect visual functions or refractive development\n* prior treatment of myopic control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc."}, 'identificationModule': {'nctId': 'NCT03538002', 'briefTitle': 'The Effect of Blue-light Filtering Spectacle Lenses on Myopia Progression in Schoolchildren', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Does Blue-light Filtering Spectacle Lens Promote Myopia Progression in Schoolchildren', 'orgStudyIdInfo': {'id': '05161146'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional anti-reflection coated spectacle lens', 'description': 'Single vision lenses with correction of distant refraction and conventional anti-reflection coating'}, {'type': 'EXPERIMENTAL', 'label': 'Blue-light filtering spectacle lenses', 'description': 'Single vision lenses with correction of distant refraction and blue-light filtering coating', 'interventionNames': ['Device: Blue-light filtering spectacle lenses']}], 'interventions': [{'name': 'Blue-light filtering spectacle lenses', 'type': 'DEVICE', 'description': 'This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.', 'armGroupLabels': ['Blue-light filtering spectacle lenses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Centre of Myopia Research, School of Optometry, The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Ka Man Chun, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Myopia Research, The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}