Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-28 @ 7:34 PM
Study NCT ID:
NCT06714994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
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': ['INVESTIGATOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1980}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-12-03', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attendance at academic high school', 'timeFrame': 'In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.', 'description': 'This will be assessed by systematically contacting parents, teachers and students to ascertain enrolment status, which REAP has used to obtain \\> 97% follow-up in previous studies of high school accession. In the event of inconsistent responses, priority will be given to responses of parents, then teachers and finally students'}], 'secondaryOutcomes': [{'measure': 'Compliance with spectacle wear', 'timeFrame': 'After 12 months of participant followup', 'description': "Actual presence of spectacles on the child's face (rather than having glasses at school)at the time of an unannounced examination."}, {'measure': 'Classroom use of blackboards versus textbooks', 'timeFrame': 'After 12 months of participant followup', 'description': 'Frequency of blackboard versus textbook use in the major subjects (Maths Chinese, English) on a questionnaire administered to teachers, and answered as "all", "most", "about half", little" or "none" of teaching.'}, {'measure': 'Cost effectiveness of intervention.', 'timeFrame': 'At study closeout, after 32 months of participant follow up', 'description': 'Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control, Intervention costs will comprise the screening test glasses (including replacements).'}, {'measure': 'Depression and Anxiety', 'timeFrame': 'At baseline and 12 months post-treatment', 'description': 'Depression and anxiety score measured with Anxiety Stress Scale (DASS). The score range for depression, anxiety and stress are 0-42, with higher score indicates more severe mental health problems.'}, {'measure': 'Self Esteem', 'timeFrame': 'At baseline and 12 months post-treatment', 'description': 'Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem.'}, {'measure': 'Emotional and behavioral problems', 'timeFrame': 'At baseline and 12 months post-treatment', 'description': 'Emotional and behavioral problems score using the Strengths and Difficulties Questionnaire (SDQ), with difficulties score ranges from 0 to 40, Prosocial scale ranges from 0-10,with higher score indicates severe mental health and behavioral problems.'}, {'measure': 'Progression of Shortsightedness', 'timeFrame': 'At baseline and 12 months post-treatment', 'description': 'Progression of Shortsightedness will be measured using change in refraction over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '25249453', 'type': 'BACKGROUND', 'citation': "Ma X, Zhou Z, Yi H, Pang X, Shi Y, Chen Q, Meltzer ME, le Cessie S, He M, Rozelle S, Liu Y, Congdon N. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial. BMJ. 2014 Sep 23;349:g5740. doi: 10.1136/bmj.g5740."}, {'pmid': '29801081', 'type': 'BACKGROUND', 'citation': 'Ma Y, Congdon N, Shi Y, Hogg R, Medina A, Boswell M, Rozelle S, Iyer M. Effect of a Local Vision Care Center on Eyeglasses Use and School Performance in Rural China: A Cluster Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):731-737. doi: 10.1001/jamaophthalmol.2018.1329.'}, {'pmid': '7726811', 'type': 'BACKGROUND', 'citation': 'Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.'}, {'pmid': '37853499', 'type': 'BACKGROUND', 'citation': 'Jiang C, Zhu Y, Luo Y, Tan CS, Mastrotheodoros S, Costa P, Chen L, Guo L, Ma H, Meng R. Validation of the Chinese version of the Rosenberg Self-Esteem Scale: evidence from a three-wave longitudinal study. BMC Psychol. 2023 Oct 18;11(1):345. doi: 10.1186/s40359-023-01293-1.'}, {'pmid': '9255702', 'type': 'BACKGROUND', 'citation': 'Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether provision of free spectacles to rural-dwelling Chinese secondary school students with visually-significant refractive error, together with a teacher-based incentive to promote their use, increases the proportion of children going on to academic high school, as opposed to dropping out or pursuing a vocational track.', 'detailedDescription': "The investigators propose in the current trial to significantly expand the evidence base for spectacle distribution as the most-effective health intervention to improve educational opportunities for China's under-served rural children and adolescents by assessing impact on school attainment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Year 1 students (about 12-15 years old) from schools in county-level cities and below in Liaoning Province\n* Uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes\n* Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected7 (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D\n* Best corrected visual acuity ≥6/7.5 in either eye\n\nExclusion Criteria:\n\n* Hyperopia ≥2.00 D\n* Presence of visually-significant ocular condition besides refractive error'}, 'identificationModule': {'nctId': 'NCT06714994', 'briefTitle': 'Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment', 'organization': {'class': 'OTHER', 'fullName': 'He Eye Hospital'}, 'officialTitle': 'Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment', 'orgStudyIdInfo': {'id': 'SWISH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': "Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the teacher. All students will be advised to wear glasses as much as possible during the study to ensure clear vision.", 'interventionNames': ['Device: free spectacles']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China.'}], 'interventions': [{'name': 'free spectacles', 'type': 'DEVICE', 'description': 'Children will receive free spectacles', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110034', 'city': 'Shenyang', 'country': 'China', 'contacts': [{'name': 'Guanghao Qin', 'role': 'CONTACT', 'email': 'qinguanghao@hsyk.com.cn'}], 'facility': 'He Eye Specialist Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Guanghao Qin', 'role': 'CONTACT', 'email': 'qinguanghao@hsyk.com.cn', 'phone': '0086-18842664420'}, {'name': 'Jiayan Chen', 'role': 'CONTACT', 'email': 'chenjiayan@hsyk.com.cn', 'phone': '0086-18304019060'}], 'overallOfficials': [{'name': 'Guanghao Qin', 'role': 'STUDY_CHAIR', 'affiliation': 'He Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Anonymized datasets generated and analyzed during the current study will be made available on reasonable request by the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'He Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}