Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
NCT ID: NCT06714994
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1980 participants
INTERVENTIONAL
2024-12-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Study group
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.
free spectacles
Children will receive free spectacles
Control group
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.
No interventions assigned to this group
Interventions
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free spectacles
Children will receive free spectacles
Eligibility Criteria
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Inclusion Criteria
* Uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes
* 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
* Best corrected visual acuity ≥6/7.5 in either eye
Exclusion Criteria
* Presence of visually-significant ocular condition besides refractive error
11 Years
16 Years
ALL
No
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Guanghao Qin
Role: STUDY_CHAIR
He Eye Hospital
Locations
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He Eye Specialist Hospital
Shenyang, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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SWISH
Identifier Type: -
Identifier Source: org_study_id