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NCT Number: NCT06714994

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

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.

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Key information

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

He Eye Specialist Hospital

Shenyang, 110034, China

Location contact

Guanghao Qin

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

free spectacles

Device

Children will receive free spectacles

Primary outcomes

  1. Attendance at academic high school

    Time frame: 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 outcomes

  1. Compliance with spectacle wear

    Time frame: 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.

  2. Classroom use of blackboards versus textbooks

    Time frame: 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.

  3. Cost effectiveness of intervention.

    Time frame: 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).

  4. Depression and Anxiety

    Time frame: 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.

  5. Self Esteem

    Time frame: 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.

  6. Emotional and behavioral problems

    Time frame: 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.

  7. Progression of Shortsightedness

    Time frame: At baseline and 12 months post-treatment

    Progression of Shortsightedness will be measured using change in refraction over time

Study contacts

Contact information is provided by the study sponsor or research team.

Guanghao Qin

CONTACT

[email protected]

0086-18842664420

Jiayan Chen

CONTACT

[email protected]

0086-18304019060

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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