Myopia
Conditions
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.
Interventions
DEVICEfree spectacles
Children will receive free spectacles
Sponsors
He Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance at academic high school | In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classroom use of blackboards versus textbooks | After 12 months of participant followup | 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. |
| Cost effectiveness of intervention. | At study closeout, after 32 months of participant follow up | 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). |
| Depression and Anxiety | At baseline and 12 months post-treatment | 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. |
| Compliance with spectacle wear | After 12 months of participant followup | Actual presence of spectacles on the child's face (rather than having glasses at school)at the time of an unannounced examination. |
| Emotional and behavioral problems | At baseline and 12 months post-treatment | 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. |
| Progression of Shortsightedness | At baseline and 12 months post-treatment | Progression of Shortsightedness will be measured using change in refraction over time |
| Self Esteem | At baseline and 12 months post-treatment | Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem. |
Countries
China
Contacts
Primary ContactGuanghao Qin
Backup ContactJiayan Chen
Outcome results
None listed