Plain English Summary
Background and study aims:
World Bank studies suggest that approximately 1 in 10 of all primary school children in developing countries have problems with their eyesight. The majority of childrens eye problems are caused by refraction errors, which can be corrected with properly fitted eyeglasses. However, most children with refraction problems in low-income countries do not have glasses. Studies in Southern China show that 1 in 5 children have uncorrected vision, and impaired vision among students in rural China, can have potential adverse consequences on education.
Who can participate?
All fourth and fifth grade students in the sample schools.
What does the study involve?
All fourth and fifth grade students in the sample schools will be screened for vision problems. Those children found to have uncorrected vision will be prescribed and fitted with a pair of glasses. Depending on the group they are assigned to, they will either receive a free pair of glasses, receive a voucher to go pick up a free pair of glasses from the nearest optician, or receive nothing (the control). Each of these groups will also receive an educational training which focuses on the benefits of proper eye care. However, a sub group will receive no glasses and no training. By the end of the study, all students with uncorrected vision in the sample, regardless of which group they were assigned to, will be given a pair of glasses.
What are the possible benefits and risks of participating?
Students with uncorrected vision will receive a free pair of quality spectacles. There are no significant risks to participating.
Where is the study run from?
Stanford University, USA and Beijing, China
When is study starting and how long is it expected to run for?
October 2012 to June 2013
Who is funding the study?
Luxottica Corporation, Essilor Corporation, CLSA Investment Brokerage and private donors.
Who is the main contact?
Matthew Boswell
boswell@stanford.edu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Seeing is learning: providing vision care to rural primary school children in China: a cluster randomized trial
Acronym
Study hypothesis
We predict twelve percent of the sample will have uncorrected vision problems [primarily short-sightedness (i.e., myopia)]. We predict that correcting these vision problems will raise the academic achievement among student who receive corrective glasses.
Ethics approval
Stanford University Institutional Review Board, 15 July 2012, ref: 6208
Zhongshan University [Sun Yat-sen University] Institutional Review Board
Study design
Cluster randomized control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vision care
Intervention
Free Glasses (80 schools)
Voucher for Free Glasses (can be transferred at the nearest eyeglass shop in the county seat; 80 schools)
Control (80 schools)
Education intervention (crosscutting; 120 schools)
Pure control (no education, no glasses; 40 schools)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Messured in both a baseline and follow-up survey:
1. Number of children wearing glasses
2. School performance, determined from a standardized test we will administer and students grades
Secondary outcome measures
Knowledge of vision care and mental health, such as anxiety, mental health, self-esteem, and enjoyment of school.
Overall trial start date
20/09/2012
Overall trial end date
30/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Fourth and fifth grade students in 250 randomly selected primary schools in Yulin Prefecture, Shaanxi Province and Tianshui Prefecture, Gansu Province.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Our participation goal is about 20,000 fourth and fifth grade students.
Participant exclusion criteria
Students with ailments or conditions that prevents them from being safely dilated and given a proper corrective vision prescription (existing literature indicates this would be at most one percent of the sample population)
Recruitment start date
20/09/2012
Recruitment end date
30/06/2013
Locations
Countries of recruitment
China
Trial participating centre
Stanfor University
Stanford
CA 94305
United States of America
Sponsor information
Organisation
Stanford University (USA)
Sponsor details
450 Serra Mall
Stanford
CA 94305
United States of America
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Luxottica Corporation (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Essilor Corporation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CLSA Investments (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Private Donor
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25249453
Publication citations
-
Results
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, 349, g5740.