Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities

NCT04077086 | Recruiting DMC

• 1 other identifier: MR/S023208/1
• Study Type: interventional
• Target: 10,000
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Refractive Errors

Keywords

Refractive error; Myopia; Academic high school attendance; Education attainment; Spectacle wear compliance; Mental health well-being; Progression of shortsightedness

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (8)

• Compliance with spectacle wear

  After 12 months of participant followup

• Blackboard use

  After 12 months of participant followup

• Cost effectiveness of intervention.

  At study closeout, after 32 months of participant followup

• Depression and Anxiety

  At baseline and 12 months post-treatment

• Self Esteem

  At baseline and 12 months post-treatment

Study Arms (2)

Intervention

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 study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if 80% spectacle compliance as measured across three separate unannounced inspections was achieved, they will be given an incentive of an conditional cash transfer. The cash transfer will be deposited into the teacher's bank accounts directly.

Device: Spectacles

Control

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. No teacher incentive will be offered. 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

Spectacles DEVICE

Intervention 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.

Also known as: Glasses

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Presence of visually-significant ocular condition besides refractive error

Sponsors & Collaborators

• Queen's University, Belfast: lead
• 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

Study Sites (3)

He Eye Specialist Hospital

Shenyang, Liaoning, 110163, China

RECRUITING

Ningxia University

Yinchuan, Xixia, 750021, China

NOT YET RECRUITING

Centre for Public Health

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Nathan Congdon, MD, MPH

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan Congdon, MD, MPH

CONTACT

07748751393; ncongdon1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study personnel assessing trial outcomes will be masked as to children's study group assignment, which will be simplified by the fact that there will be participants with and without glasses at both Intervention and Control schools. It is not ethical in this setting to provide Control participants with placebo treatment (glasses with zero power lenses), but students, parents and teachers will not be informed of either the overall design of the study or the explicit treatment intervention assignment. Only one school will be selected in each township, minimizing the possibility of cross arm communication and contamination.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Children in Year 1 at 111 randomly-selected middle-schools in Liaoning, northern China, will be randomized by school to receive free glasses and a teacher-based incentive to promote wear, or prescriptions only.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: September 4, 2019
• Study Start: November 28, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CN (2)