Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-02 @ 5:40 AM
Study NCT ID:
NCT04825769
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2021-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Light Intervention for Myopia Prevention
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-27', 'size': 109974, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-29T07:40', 'hasProtocol': True}, {'date': '2021-03-27', 'size': 102369, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-29T07:40', 'hasProtocol': False}, {'date': '2021-03-27', 'size': 102369, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-29T07:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'One-year cumulative incidence of myopia (%) in the intervention group and the control group.', 'timeFrame': '1 year', 'description': 'Myopia is defined as the cycloplegic spherical equivalent of either eye ≤-0.5D'}], 'secondaryOutcomes': [{'measure': 'The progress of spherical equivalent(SE,D) of children in intervention group and control group.', 'timeFrame': '1 year', 'description': 'The spherical equivalent(SE,D) will be measured by autorefractor(KR-8900, Topcon).'}, {'measure': 'The progress of axial length of children in intervention group and control group.', 'timeFrame': '1 year', 'description': 'The axial length will be measured using IOLMaster.'}, {'measure': 'The progress of choroidal thickness in children in pre-myopia state in intervention group and control group.', 'timeFrame': '1 year', 'description': 'The choroidal thickness will be measured using SS-OCT.'}, {'measure': 'The change of uncorrected visual acuity (UCVA) of children in intervention group and control group.', 'timeFrame': '1 year', 'description': 'The uncorrected visual acuity (UCVA) will be measured using a mounted and illuminated E chart of the Early Treatment Diabetic Retinopathy study (ETDRS) charts.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children and adolescents', 'Myopia', 'Prevention and control', 'Red light'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '37099298', 'type': 'DERIVED', 'citation': 'He X, Wang J, Zhu Z, Xiang K, Zhang X, Zhang B, Chen J, Yang J, Du L, Niu C, Leng M, Huang J, Liu K, Zou H, He M, Xu X. Effect of Repeated Low-level Red Light on Myopia Prevention Among Children in China With Premyopia: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e239612. doi: 10.1001/jamanetworkopen.2023.9612.'}]}, 'descriptionModule': {'briefSummary': 'To explore the effectiveness of using low-intensity single-wavelength red light to prevent myopia in schoolchildren, and to provide a feasible scheme for reducing the incidence of myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Students of grade 1-4 in the participating schools;\n* Students' eyes have no myopia, that is the cycloplegic spherical equivalent（SE） \\>-0.50D, and at least one eye accords with the pre-myopic state, that is -0.50D \\<cycloplegic SE≤0.50D;\n* Students whose mother and/or father are in myopia status (SE \\< -3.0D for either of eyes);\n* Students whose parents sign informed consent and agree to let their kids participate in baseline screen and follow-up examinations and surveys.\n\nExclusion Criteria:\n\n* Students whose parents do not sign informed consent;\n* Students who have strabismus and/or other binocular vision abnormality;\n* Students who have other eye diseases and/or systematic diseases;\n* Students who have DC \\<=-1.5D;\n* Students whose difference of SE between the two eyes \\>=1.5D;\n* Students who meet the standards with which investigators and study physicians think it is not appropriate to enroll."}, 'identificationModule': {'nctId': 'NCT04825769', 'briefTitle': 'Red Light Intervention for Myopia Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'A Randomized Controlled Trial of Low-dose Single-wavelength Red Light in the Decrease of Myopia Incidence Rate in the Setting of School.', 'orgStudyIdInfo': {'id': 'SHYB2021001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Red light irradiation was conducted at school from Monday to Friday and at home everyday in summer and winter holiday twice a day for 3 minutes per time, with an interval of 4 hours', 'interventionNames': ['Device: LLLT（Low Level Laser Therapy）']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No intervention'}], 'interventions': [{'name': 'LLLT（Low Level Laser Therapy）', 'type': 'DEVICE', 'description': '2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Xiangui He', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xiangui He', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Eye Disease Prevention and Treatment Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}