Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-16
SponsorHe Eye Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Hyperopia ≥2.00 D

Presence of visually-significant ocular condition besides refractive error

Trial design

Design model

Parallel

Treatments tested in this trial

  • free spectacles

    Device

    Children will receive free spectacles

Treatment groups

1,980 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Attendance at academic high school

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

Time frame
In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.

Secondary outcomes

1

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.

Time frame
After 12 months of participant followup
2

Classroom use of blackboards versus textbooks

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.

Time frame
After 12 months of participant followup
3

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).

Time frame
At study closeout, after 32 months of participant follow up
4

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.

Time frame
At baseline and 12 months post-treatment

Other outcomes

Sponsors and contacts

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