Clinical trial NCT06714994: Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
Official title: Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 1980
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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

Primary outcomes:
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.
Secondary outcomes:
measure: Compliance with spectacle wear
timeFrame: After 12 months of participant followup
measure: Classroom use of blackboards versus textbooks
timeFrame: After 12 months of participant followup
measure: Cost effectiveness of intervention.
timeFrame: At study closeout, after 32 months of participant follow up
measure: Depression and Anxiety
timeFrame: At baseline and 12 months post-treatment
measure: Self Esteem
timeFrame: At baseline and 12 months post-treatment
measure: Emotional and behavioral problems
timeFrame: At baseline and 12 months post-treatment
measure: Progression of Shortsightedness
timeFrame: At baseline and 12 months post-treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Specialist Hospital
Study officials:
affiliation: He Eye Hospital
name: Guanghao Qin
role: STUDY_CHAIR
References:
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.
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.
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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.
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.