Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-30 @ 11:48 AM
Study NCT ID:
NCT06623760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2024-09-30', 'studyFirstSubmitQcDate': '2024-09-30', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention', 'timeFrame': 'at baseline, , and at the 12th month of the intervention.', 'description': 'The ocular physiological parameters, including axial length (AL), horizontal and vertical corneal curvature (K1 and K2), were measured using an optical biometer (model IOL Master 700). Each eye was measured three times, and if the difference between any two measurements exceeded 0.05 mm, the process was repeated until the difference was less than this value.An objective examination method was used under non-cycloplegic conditions (i.e., without pupil dilation), utilizing a tabletop automatic refractometer (ISO 10342-2010 Ophthalmic Instruments - Refractometers). The spherical equivalent (SE) was calculated as follows: SE = sphere power + 1/2 cylinder power.'}], 'secondaryOutcomes': [{'measure': 'The incidence of myopia.', 'timeFrame': 'at baseline, and at the 12th month of the intervention.', 'description': 'The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Axial Length, Eye', 'Myopia', 'Myopia Progression']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial of a desk and chair adaptation intervention involving primary school students and their parents or primary caregivers. We compared the myopia status of students in the intervention and control groups before and after the intervention to confirm the effect of the desk and chair adaptation intervention on the development of myopia in students.', 'detailedDescription': 'In this study, two pilot schools in Anhui Province were selected , and all students were examined by ophthalmologists, and their heights and the heights of their desks and chairs were measured in order to investigate the association between desk and chair adaptations and myopia. One of the elementary school was randomly selected for a one-year desk and chair adaptation intervention to compare the occurrence of myopia and axial growth of the students before and after the intervention in the two schools.\n\nTranslated with DeepL.com (free version)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.\n* Able to cooperate with eye examinations and questionnaires.\n\nExclusion Criteria:\n\n* Communication barriers, unable to cooperate.\n* Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.\n* Children currently using orthokeratology lenses or rigid contact lenses.\n* Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.'}, 'identificationModule': {'nctId': 'NCT06623760', 'briefTitle': 'Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'officialTitle': 'Intervention Study：Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students', 'orgStudyIdInfo': {'id': '20240901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desk and chair adaptation interventions', 'description': 'Adjustment of the height of desks and chairs according to the height of each student, intervention lasting one year', 'interventionNames': ['Device: Desk and chair adaptation interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Continued use of original desks and chairs', 'description': 'No change in height of desks and chairs, use as usual'}], 'interventions': [{'name': 'Desk and chair adaptation interventions', 'type': 'DEVICE', 'description': 'Adjustment of the height of tables and chairs to the height of each pupil in accordance with Functional sizes and technical requirements of chairs and tables for educational institutions (GB/T 3976--2014）, with a duration of intervention of one year。', 'armGroupLabels': ['Desk and chair adaptation interventions']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': '韶君 许', 'role': 'CONTACT', 'email': '601792160@qq.com', 'phone': '18055151289'}, {'name': '亚新 张', 'role': 'CONTACT', 'email': '824178531@qq.com', 'phone': '18756589920'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fangbiao Tao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fangbiao Tao', 'investigatorAffiliation': 'Anhui Medical University'}}}}