Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: free spectacles.
- Who it may be relevant to
- Registry conditions: Myopia. Basic parameters: 11 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device free spectacles
Children will receive free spectacles
Primary outcome measures
- Attendance at academic high school [Time frame: In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.]
Secondary outcome measures (7)
- Compliance with spectacle wear [Time frame: After 12 months of participant followup]
- Classroom use of blackboards versus textbooks [Time frame: After 12 months of participant followup]
- Cost effectiveness of intervention. [Time frame: At study closeout, after 32 months of participant follow up]
- Depression and Anxiety [Time frame: At baseline and 12 months post-treatment]
- Self Esteem [Time frame: At baseline and 12 months post-treatment]
- Emotional and behavioral problems [Time frame: At baseline and 12 months post-treatment]
- Progression of Shortsightedness [Time frame: At baseline and 12 months post-treatment]
Eligibility criteria
Inclusion criteria
- Year 1 students (about 12-15 years old) from schools in county-level cities and below in Liaoning Province
- 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
- Hyperopia ≥2.00 D
- Presence of visually-significant ocular condition besides refractive error
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
China · 1 center
- He Eye Specialist Hospital — Shenyang
Publications
- 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 25249453
- 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 29801081
- 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 7726811
- 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 37853499
- 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. PMID 9255702
Identifiers
NCT: NCT06714994 · SWISH