Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-30 @ 4:12 PM
Study NCT ID:
NCT05203432
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Light Intervention on Myopic Progression
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': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-01-10', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of axial length', 'timeFrame': 'at least 1 year', 'description': 'AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster'}], 'secondaryOutcomes': [{'measure': 'Change of spherical equivalent', 'timeFrame': 'at least 1 year', 'description': 'Spherical equivalent as measured by cycloplegia autorefraction'}, {'measure': 'Change of choroidal thickness', 'timeFrame': 'at least 1 year', 'description': 'Choroidal thickness will be measured using SS-OCT'}, {'measure': 'Change of uncorrected visual acuity', 'timeFrame': 'at least 1 year', 'description': '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': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'To explore the effectiveness of using repeated low-level red-light therapy to slow myopia progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age at enrolment: 6-12 years;\n2. At least one eye with spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D), and stigmatism of 1.50 D or less;\n3. Anisometropia of 1.5 D or less;\n4. The BCVA of distant vision is at least 0.8;\n5. Myopia progressed more than 0.5D in the past year;\n6. Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;\n7. Written informed consent of guardian and child.\n\nExclusion Criteria:\n\n1. Strabismus, amblyopia or other ocular abnormalities;\n2. Other systemic abnormalities;\n3. Prior treatment of myopia control in 6 months, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye;\n4. Atropine allergy;\n5. Other situations that not suitable for participating in the trial as judged by the researcher.'}, 'identificationModule': {'nctId': 'NCT05203432', 'briefTitle': 'Red Light Intervention on Myopic Progression', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Eye Disease Prevention and Treatment Center'}, 'officialTitle': 'The Effect and Safety of Red Light Intervention on Myopic Progression of Myopic Children: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '21Y11910000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Red Light Intervention', 'description': 'Repeated Low-Level Red-Light Therapy', 'interventionNames': ['Device: Red Light Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low concentration atropine', 'description': '0.01% atropine', 'interventionNames': ['Drug: Atropine']}], 'interventions': [{'name': 'Red Light Intervention', 'type': 'DEVICE', 'description': 'Repeated Low-Level Red-Light Therapy', 'armGroupLabels': ['Red Light Intervention']}, {'name': 'Atropine', 'type': 'DRUG', 'description': '0.01% atropine', 'armGroupLabels': ['Low concentration atropine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201103', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangui He', 'role': 'CONTACT', 'email': 'hxgcrco@shsyf.com', 'phone': '+862153555032'}], 'facility': 'Shanghai Eye Disease Prevention and Treatment Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiannan Huang', 'role': 'CONTACT', 'email': 'miller23@126.com', 'phone': '+8602153555032'}, {'name': 'Xiangui He', 'role': 'CONTACT', 'email': 'hxgcrco@shsyf.com', 'phone': '+8602153555032'}], 'overallOfficials': [{'name': 'Jiannan Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Eye Disease Prevention and Treatment Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Eye Disease Prevention and Treatment Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}