Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04045951
Status:
UNKNOWN
Last Update Posted:
2019-08-07
First Post:
2019-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcomes assessors involved in data management and analysis will be blinded to the group assignment. The study participants, the investigators responsible for randomization will not be masked.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2138}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of SER development of at least -1.0 dioptres (D)', 'timeFrame': 'up to 2 year', 'description': 'SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -1.0 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 2 year'}, {'measure': 'Incidence of SER development of at least -0.5 dioptres (D)', 'timeFrame': 'up to 1 year', 'description': 'SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year'}], 'secondaryOutcomes': [{'measure': 'Changes in SER \\ and AL', 'timeFrame': 'Up to 1 year', 'description': 'Changes in SER \\\\ and AL will be calculated; AL: axial length'}, {'measure': 'Changes in SER \\ and AL', 'timeFrame': 'Up to 2 year', 'description': 'Changes in SER \\\\ and AL will be calculated; AL: axial length'}, {'measure': 'Changes in proportion of children using atropine', 'timeFrame': 'Up to 1 year', 'description': 'Changes in proportion of children using atropine will be calculated'}, {'measure': 'Changes in proportion of children using atropine', 'timeFrame': 'Up to 2 year', 'description': 'Changes in proportion of children using atropine will be calculated'}, {'measure': 'Changes in proportion of children using orthokeratology lenses', 'timeFrame': 'Up to 1 year', 'description': 'Changes in proportion of children using orthokeratology lenses will be calculated'}, {'measure': 'Changes in proportion of children using orthokeratology lenses', 'timeFrame': 'Up to 2 year', 'description': 'Changes in proportion of children using orthokeratology lenses will be calculated'}, {'measure': 'Changes in proportion of children using spectacles', 'timeFrame': 'Up to 1 year', 'description': 'Changes in proportion of children using spectacles will be calculated'}, {'measure': 'Changes in proportion of children using spectacles', 'timeFrame': 'Up to 2 year', 'description': 'Changes in proportion of children using spectacles will be calculated'}, {'measure': "Changes in child's average outdoor activity time per day", 'timeFrame': 'Up to 1 year', 'description': "Changes in child's average outdoor activity time per day will be calculated"}, {'measure': "Changes in child's average outdoor activity time per day", 'timeFrame': 'Up to 2 year', 'description': "Changes in child's average outdoor activity time per day will be calculated"}, {'measure': "Changes in child's average screen time per day", 'timeFrame': 'Up to 1 year', 'description': "Changes in child's average screen time per day will be calculated"}, {'measure': "Changes in child's average screen time per day", 'timeFrame': 'Up to 2 year', 'description': "Changes in child's average screen time per day will be calculated"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vision Disorders', 'Artificial intelligence', 'Myopia prediction'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm', 'detailedDescription': 'The investigators propose to enroll myopia children aged 8-10 in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 8-10\n* Has the record of eye refraction examined in the past year, SER\\<-0.5D\n* Current BCVA≥0.8, SER\\<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D\n* Written informed consents provided\n\nExclusion Criteria:\n\n* Definitive diagnosis of other diseases except for refractive error\n* Previous eye surgery\n* Previous usage of orthokeratology lenses and atropine\n* Unwilling to participate in this trial'}, 'identificationModule': {'nctId': 'NCT04045951', 'briefTitle': 'Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': "Effect of Using Myopia Prediction Algorithm on Myopia School-aged Children's Eye Refraction in China: a Multi-center Randomized Control Trial", 'orgStudyIdInfo': {'id': 'CCPMOH2019-China-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Using myopia prediction algorithm', 'description': 'After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. Meanwhile, myopia prediction algorithm will be used to predict SER at 3 years.', 'interventionNames': ['Other: Myopia prediction algorithm']}, {'type': 'NO_INTERVENTION', 'label': 'Not using myopia prediction algorithm', 'description': 'After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.'}], 'interventions': [{'name': 'Myopia prediction algorithm', 'type': 'OTHER', 'description': 'Candidate predictors included age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.', 'armGroupLabels': ['Using myopia prediction algorithm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510623', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yahan Yang', 'role': 'CONTACT', 'phone': '+86-15521013933'}], 'facility': 'Zhongshan Ophthalmic Centre', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yahan Yang', 'role': 'CONTACT', 'email': 'yah.yang39@hotmail.com', 'phone': '+8615521013933'}, {'name': 'Haotian Lin', 'role': 'CONTACT', 'email': 'haot.lin@hotmail.com', 'phone': '+8613802793086'}], 'overallOfficials': [{'name': 'Haotian Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}