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

Refractive Errors Clinical Trial

— SWISH  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04077086
• Other study ID #: MR/S023208/1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: December 2021
• Source: Queen's University, Belfast
• Contact: Nathan Congdon, MD, MPH
• Phone: 07748751393
• Email: ncongdon1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4800
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Device:
• Spectacles
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.

Locations

Country	Name	City	State
China	Ningxia University	Yinchuan	Xixia
United Kingdom	Centre for Public Health	Belfast	Northern Ireland

Sponsors (6)

Lead Sponsor	Collaborator
Queen's University, Belfast	Clearly Initiatives, New England College of Optometry, Ningxia Medical University, Stanford University, Zhongshan Ophthalmic Center, Sun Yat-sen University

Countries where clinical trial is conducted

China,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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