Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities

Study Overview
=================
Brief Summary
-----------------
Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already shown in other trials that giving children free glasses leads to better grades and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural western China goes on to a regular, non-vocational high school. The investigators would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them. Study Plan: The investigators will choose 130 middle schools at random in Ningxia, western China, and all children in Years 1 and 2 (one class each) at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses (Intervention) or a group getting just glasses prescriptions (Control.) The main study outcome will be the proportion of children going on to academic (as opposed to vocational) high school, and the study is powered to detect a 10% difference in this figure between groups.The study will also assess children's test scores, whether they wear their glasses at school, and how often they use blackboards (which disadvantage short-sighted children) vs textbooks to learn from. These other outcomes will help us to better understand the causal pathway between vision and high school attendance. We will also study the total cost of providing glasses glasses and the teacher support to wear them per additional student attending academic high school. The hypothesis of this study is that providing glasses will increase academic high school attendance.

Detailed Description
-----------------
Research question: Will providing free glasses to myopic rural Chinese students, with a teacher incentive to promote use, increase academic high school attendance? Design: Cluster-randomised controlled trial Rationale: Rural Chinese children have high myopia prevalence, but poor access to glasses. Our previous trials show giving free glasses significantly improves academic performance, with greater effect size than parental education or family income, equaling or exceeding other classroom-based medical interventions. Non-vocational (academic) high school attendance is only 30% in rural western China. Strong evidence of educational benefit from glasses is needed to spur adoption of national distribution programs. Methods: Children in Year 1 and 2 (1 class each) at 130 randomly-selected middle schools in Ningxia, western China, will be randomized by school to receive free glasses and a trial-proven teacher-based incentive to promote wear (Intervention) or prescriptions only (Control). The main outcome 2-3 years later will be high school attendance (powered to detect 10% difference between study groups); secondary outcomes of compliance, test scores and use of near versus distance classroom learning aids will elucidate biological plausibility of a causal pathway between myopia correction and learning. Local knowledge and attitudes about myopia and spectacle use and intervention cost-effectiveness will be studied. Statistical methods to be employed in the analysis and justification for the choice of sample size: Adjusted- and unadjusted-comparison of the difference between study groups Of academic high school attendance of mathematics test performance at endline (adjusted for baseline), of observed spectacle wear at un-announced examinations Sample size: Assuming 50% of children will fail vision screening, 70% of these needing glasses, with loss to follow-up=10%, α=0.05, intra-class correlation=0.15, explained variation by covariates=0.40, difference between the groups in the main study outcome=10%, high-school attendance rate in the Control group=30%, a sample size of 130 middle-schools (65 in each group) will provide power=85%.

Official Title
-----------------
SWISH (See Well to Stay In ScHool): Randomised Trial of Spectacle Distribution to Secondary School Children With Myopia to Increase Academic High School Attendance Rates in Rural Communities)

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: Spectacles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Year 1 and 2 classes (likely age 12-15 years) at the recruited schools Have uncorrected (without glasses) visual acuity of ≤6/12 in either eye; Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected (myopia ≤-0.75 diopters (D), hyperopia ≥2.00 D, or astigmatism (non-spherical refractive error) ≥1.00 D); Visual acuity can be improved to >6/12 in both eyes with glasses. Exclusion Criteria: Presence of visually-significant ocular condition besides refractive error

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children in Year 1 and 2 at 130 randomly-selected middle-schools in Ningxia, western China, will be randomized by school to receive free glasses and a teacher-based incentive to promote wear, or prescriptions only.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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 study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if 80% spectacle compliance as measured across three separate unannounced inspections was achieved, they will be given an incentive of an conditional cash transfer. The cash transfer will be deposited into the teacher's bank accounts directly. | Device: Spectacles<br>* Intervention group children in middle school Years 1 and 2 will receive spectacles at the beginning of the academic year (September 2021). Assuming that the relevant effects of treatment (glasses wear) on the main study outcome are complete once examinations determining high school attendance are finished at the end of Middle School Year 3, Intervention participants will have undergone either 22 months (September 2021 to July 2023 for those recruited in Year 2) or 34 months (September 2021 to July 2024 for those recruited in Year 1) of treatment by the endpoint of the trial.<br>* Other names: Glasses;|
| No Intervention: Control<br>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. No teacher incentive will be offered. 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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Academic high school attendance | Proportion of children who continue to academic high school as opposed to vocational high school or no additional schooling, assessed by systematically contacting parents, teachers and students to ascertain enrolment status | In September following completion of Year 3 of Middle School. This occurs after 24 months of participant followup for children recruited in middle school Year 2 and after 36 months of participant followup for those recruited in middle school year 1. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with spectacle wear | Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination. | After 8, 20 and 32 months of participant followup | 
| Mathematics score | Scores at the end of each school year on a study-specific mathematics test, adjusting for baseline score. | After 8, 20 and 32 months of participant followup) | 
| Blackboard use | 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. | After 20 and 32 months of participant followup | 
| Cost effectiveness of intervention. | 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) and teacher incentives. | At study closeout, after 24 months of participant followup for those recruited in middle school Year 2 and 36 months of participant followup for those recruited in Middle School Year 1. | 
| Depression and Anxiety | 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. | At baseline and12 month post-treatment | 
| Self Esteem | Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem. | At baseline and12 month post-treatment | 
| Emotional and behavioral problems | 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. | At baseline and12 month post-treatment | 
| Parent-proxy quality of life | Parent-proxy quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life | At baseline and12 month post-treatment | 
| Child self-reported quality of life | Child self-reported quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life. | At baseline and12 month post-treatment | 
| Progression of shortsightedness | The length of the eyeball (axial length) will be measured by using a biometry measuring device (A-Scan) after applying a drop of topical anaesthetic (proxymetacaine/proparacaine) in the right eye. | At baseline, 12 month and 24 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spectacle wear compliance, Mental health well-being, Progression of shortsightedness, Refractive error, Myopia, Academic high school attendance, Education attainment