About this trial
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 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 111 middle schools at random in Liaoning, northern China, and all children in Year 1 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 whether children 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 and the teacher support to wear them per additional student attending academic high school, as well as student mental health outcomes. We will also collect data on the progression of nearsightedness. The hypothesis of this study is that providing glasses will increase academic high school attendance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Year 1 classes (likely age 12-13 years) at the recruited schools
Have uncorrected (without 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 corrected (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D);
Visual acuity can be improved to >= 6/7.5 in at least one eye with glasses.
Disqualifiers
Presence of visually-significant ocular condition besides refractive error
Trial design
Parallel
Treatments tested in this trial
Spectacles
DeviceIntervention group children in middle school Year 1 will receive spectacles in December 2024. 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 32 months (December 2024 - July 2027) of treatment by the endpoint of the trial.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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Queen's University, Belfast
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborator
Stanford University
Collaborator
New England College of Optometry
Collaborator
Clearly
Collaborator
Ningxia Medical University
Collaborator
He Eye Hospital
Collaborator
He University
Collaborator