Condition category
Eye Diseases
Date applied
17/09/2012
Date assigned
25/09/2012
Last edited
26/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 children’s 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

Contact information

Type

Scientific

Primary contact

Dr Scott Rozelle

ORCID ID

Contact details

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

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

http://www.stanford.edu/

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

  1. 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.

Additional files

Editorial Notes