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

NCT06714994 | Not Yet Recruiting

• 1 other identifier: SWISH
• Study Type: interventional
• Target: 1,980
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

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

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

Secondary Outcomes (7)

• Compliance with spectacle wear

  After 12 months of participant followup

• Classroom use of blackboards versus textbooks

  After 12 months of participant followup

• Cost effectiveness of intervention.

  At study closeout, after 32 months of participant follow up

• Depression and Anxiety

  At baseline and 12 months post-treatment

• Self Esteem

  At baseline and 12 months post-treatment

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

free spectacles DEVICE

Children will receive free spectacles

Study group

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Hyperopia ≥2.00 D
• Presence of visually-significant ocular condition besides refractive error

Sponsors & Collaborators

• He Eye Hospital: lead

Study Sites (1)

He Eye Specialist Hospital

Shenyang, 110034, China

Location

Related Publications (5)

• 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.

  PMID: 25249453 BACKGROUND

• 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.

  PMID: 29801081 BACKGROUND

• 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.

  PMID: 7726811 BACKGROUND

• 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.

  PMID: 37853499 BACKGROUND

• 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.

  PMID: 9255702 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Guanghao Qin

  He Eye Hospital

  STUDY CHAIR

Central Study Contacts

Guanghao Qin

CONTACT

0086-18842664420; qinguanghao@hsyk.com.cn

Jiayan Chen

CONTACT

0086-18304019060; chenjiayan@hsyk.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)