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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: free spectacles

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1980
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guanghao Qin; Phone Number: 0086-18842664420; Email: qinguanghao@hsyk.com.cn
• Study Contact Backup: Name: Jiayan Chen; Phone Number: 0086-18304019060; Email: chenjiayan@hsyk.com.cn

Study Locations

• China
  • Shenyang, China, 110034
    • He Eye Specialist Hospital
    • Contact: Guanghao Qin; Email: qinguanghao@hsyk.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; 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 teacher. All students will be advised to wear glasses as much as possible during the study to ensure clear vision.	Device: free spectacles; Children will receive free spectacles
No Intervention: Control group; 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. 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
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	In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and 12 months 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 and 12 months post-treatment
Progression of Shortsightedness	Progression of Shortsightedness will be measured using change in refraction over time	At baseline and 12 months post-treatment
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 12 months of participant followup
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.	After 12 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).	At study closeout, after 32 months of participant follow up
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 and 12 months post-treatment

Collaborators and Investigators

• Sponsor: He Eye Hospital
• Investigators: Study Chair: Guanghao Qin, He Eye Hospital

Publications and helpful links

General Publications

• Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
• Ma X, Zhou Z, Yi H, Pang X, Shi Y, Chen Q, Meltzer ME, le Cessie S, He M, Rozelle S, Liu Y, Congdon N. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial. BMJ. 2014 Sep 23;349:g5740. doi: 10.1136/bmj.g5740.
• Ma Y, Congdon N, Shi Y, Hogg R, Medina A, Boswell M, Rozelle S, Iyer M. Effect of a Local Vision Care Center on Eyeglasses Use and School Performance in Rural China: A Cluster Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):731-737. doi: 10.1001/jamaophthalmol.2018.1329.
• Jiang C, Zhu Y, Luo Y, Tan CS, Mastrotheodoros S, Costa P, Chen L, Guo L, Ma H, Meng R. Validation of the Chinese version of the Rosenberg Self-Esteem Scale: evidence from a three-wave longitudinal study. BMC Psychol. 2023 Oct 18;11(1):345. doi: 10.1186/s40359-023-01293-1.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SWISH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized datasets generated and analyzed during the current study will be made available on reasonable request by the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No