Seeing is learning: providing vision care to rural primary school children in China

ISRCTN	ISRCTN03252665
DOI	https://doi.org/10.1186/ISRCTN03252665
Secondary identifying numbers	N/A

Submission date: 17/09/2012
Registration date: 25/09/2012
Last edited: 02/05/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Scott Rozelle
Scientific

Stanfor University
616 Serra Street
Encina Hall
East Wing, Room 402
Stanford
CA 94305
United States of America

Study information

Study design	Cluster randomized control trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Seeing is learning: providing vision care to rural primary school children in China: a cluster randomized trial
Study objectives	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(s)	Stanford University Institutional Review Board, 15 July 2012, ref: 6208 Zhongshan University [Sun Yat-sen University] Institutional Review Board
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/09/2012
Completion date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Our participation goal is about 20,000 fourth and fifth grade students.
Key inclusion criteria	Fourth and fifth grade students in 250 randomly selected primary schools in Yulin Prefecture, Shaanxi Province and Tianshui Prefecture, Gansu Province.
Key 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)
Date of first enrolment	20/09/2012
Date of final enrolment	30/06/2013

Locations

Countries of recruitment

China
United States of America

Study participating centre

Stanfor University

Stanford
CA 94305
United States of America

Sponsor information

Stanford University (USA)
University/education

450 Serra Mall
Stanford
CA 94305
United States of America

Website	http://www.stanford.edu/
"ROR"	https://ror.org/00f54p054

Funders

Funder type

Industry

Luxottica Corporation (Italy)

No information available

Essilor Corporation (USA)

No information available

CLSA Investments (USA)

No information available

Private Donor

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/09/2014		Yes	No
Results article	results	01/07/2018		Yes	No
Results article		19/02/2022	21/02/2022	Yes	No
Results article		13/05/2023	15/05/2023	Yes	No
Results article		01/05/2025	02/05/2025	Yes	No

Editorial Notes

02/05/2025: Publication reference added.
15/05/2023: Publication reference added.
21/02/2022: Publication reference added.
30/05/2018: Publication reference added.