Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06652594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-22
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Eye" Education for Parents and Myopia Control in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 498}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-21', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fundus Image', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months.', 'description': 'Two fundus photographs were taken for each subject, centered on the optic disc and macula with a 45° field of view. If the quality of the photographs was low, they were retaken.'}], 'primaryOutcomes': [{'measure': 'Axial Length', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months.', 'description': 'Ocular biometry was used for measuring the axial length, which is the physical distance between the anterior corneal pole and the retinal structure at the posterior pole.'}, {'measure': 'Cycloplegic Refraction', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months.', 'description': 'Cycloplegic refractive errors were measured with an autorefractor.'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'Baseline, 1 month, 3 months, 6 months.', 'description': 'The visual acuity of the children is assessed through a self-administered vision test conducted by their guardians via WeChat mini program.'}, {'measure': 'Anxiety Disorder Screening 7-item Scale', 'timeFrame': 'Baseline, 6 month', 'description': "Assessing changes in parents' anxiety before and after the intervention."}, {'measure': 'Strengths and Difficulties Questionnaire', 'timeFrame': 'Baseline, 6 month.', 'description': 'Assessing changes in parent-child relationships before and after the intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children', 'Health Education', 'Anxiety']}, 'descriptionModule': {'briefSummary': "This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.", 'detailedDescription': 'After doctors\' and nurses\' education, parents would keep a diary to regulate the children\'s "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children\'s eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Children aged 5-17;\n2. Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;\n3. Best corrected visual acuity of either eye were all ≥ 1.0;\n4. The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;\n5. Astigmatism of either eye less than -5.0 D;\n6. Anisometropia ≤ -1.5 D;\n7. There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.\n8. Intraocular pressure of either eye is of 10 to 21 mmHg;\n9. On the basis of full understanding, children and their guardians sign the informed consent;\n\nExclusion Criteria:\n\n1. Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;\n2. Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;\n3. Secondary myopia, genetic disease or connective tissue- related myopia;\n4. Moderate or severe ptosis;\n5. Congenital cataract, glaucoma;\n6. Other fundus diseases other than myopic related fundus lesions;\n7. Intraocular or refractive surgery history;\n8. The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;\n\n(10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT06652594', 'briefTitle': '"Eye" Education for Parents and Myopia Control in Children', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Effect of "eye" Education for Parents on Myopia Prevention and Control in Children', 'orgStudyIdInfo': {'id': '2024-2G-1081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eye Education Intervention', 'description': "Doctors and nurses will educate parents about eye health in response to their child's myopia progression at baseline, 1 month, 3 months, 6 months.", 'interventionNames': ['Behavioral: Eye Education Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Parents in the control group will not receive eye health education information from doctors and nurses.', 'interventionNames': ['Behavioral: Control']}], 'interventions': [{'name': 'Eye Education Intervention', 'type': 'BEHAVIORAL', 'description': "Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.", 'armGroupLabels': ['Eye Education Intervention']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Parents in the control group will not receive eye health education informationfrom doctors and nurses.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Shi-Ming Li, MD, PHD', 'role': 'CONTACT', 'email': 'lishiming81@163.com', 'phone': '+86-010-58269920'}, {'name': 'Shi-Ming Li, MD, PHD', 'role': 'CONTACT'}], 'facility': 'Beijing Tongren Hospital, Beijing', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shi-Ming Li, MD, PHD', 'role': 'CONTACT', 'email': 'lishiming81@163.com', 'phone': '+86-010-58269920'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shi-Ming Li', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}