Condition category
Eye Diseases
Date applied
13/05/2015
Date assigned
27/05/2015
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Our research team has participated in a study that showed both that a large percentage of rural Chinese school children have uncorrected vision, and that fitting myopic (nearsighted) children with glasses significantly improves their academic performance. However, our interviews suggest that nothing is being done to address the problem. In this study, we will attempt to update and duplicate the results of this earlier study, and also to build on the previous research by determining the extent to which teachers influence the health behaviour of their students regarding proper vision care. The aim of the study is to determine the impact of corrective lenses on the health, educational achievement, and mental health of children in schools.

Who can participate?
Male and female seventh and eighth grade elementary school students, ranging between ages 11 and 13, attending public middle schools in rural areas of northwestern China.

What does the study involve?
Participating schools will be randomly allocated to one of two groups. One group will continue as normal, and in the other group students and teachers will undergo a 5-minute basic vision test. Those students whose basic vision test indicates a problem will continue on to the auto-refraction test. To dilate their pupils, the children will be administered 2-3 rounds of eye drops containing 1% cyclopentolate. The drops themselves may cause a mild stinging, not lasting more than 1-2 seconds. To avoid this stinging, the children will also be administered 1-2 drops of Proparacaine, a topical anesthetic. If this test indicates that students need glasses, they will receive a free, high quality pair of glasses. They will also undergo a training session in which they will learn about the importance and proper vision care.

What are the possible benefits and risks of participating?
Students who need eyeglasses will receive a free, high quality pair of glasses. Extreme side effects of cyclopentolate include dry mouth, flushing, dry skin, dizziness, or confusion. These side effects are described in the literature as "rare", with incidence of <0.1%. There are no side effects or risks associated with Proparacaine administration at these dosages. There are two normal side effects to the dilation process (not to the drug), which are blurred vision, especially at close range, which is unavoidable, and photophobia, which can be reduced by avoiding bright lights. The children will be indoors during the exam and will be given a dark place to sit. They will be instructed to avoid playing outside for the rest of the day.

Where is the study run from?
This study takes place in Shaanxi province, China.

When is the study starting and how long is it expected to run for?
Data collection will begin in September 2013 and finish in late May/early June of 2014.

Who is funding the study?
OneSight Research Foundation (USA).

Who is the main contact?
Matthew Boswell

Trial website

Contact information

Type

Public

Primary contact

Mr Matthew Boswell

ORCID ID

Contact details

Stanford University
Stanford
94305
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

28345

Study information

Scientific title

Seeing is learning: vision care for middle school students in China's rural areas

Acronym

Study hypothesis

We predict that fitting middle school students in rural China with eyeglasses and educating students about eyeglasses will reduce the rate of uncorrected vision in classrooms as well as increase student performance in school.

Ethics approval

Stanford University, 30/09/2014, Protocol ID: 28345

Study design

Interventional cluster-randomized multicenter controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Condition

Refractive error

Intervention

Participants are randomized at the school level to one of two groups:
1. Control (no glasses)
2. Free eyeglasses + information: Students and teachers will undergo a 5-minute basic vision test. Those students whose basic vision test indicates a problem will continue on to the auto-refraction test. If this test indicates that students need eyeglasses, they will receive a free, high quality pair of glasses. They will also undergo a training session in which they will learn about the importance and proper vision care.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Number of children wearing glasses, measured in both at baseline and follow-up survey 9 months after baseline

Secondary outcome measures

School performance, determined from a standardized test we will administer and students’ grade at baseline, then 9 months after baseline

Overall trial start date

01/09/2013

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female seventh and eighth grade elementary school students, ranging between ages 11 and 13, attending public middle schools in rural areas of northwestern China will be recruited by randomized selection. We are only enrolling students from township level schools. All students in these schools who agree to participate in the study will be enrolled as study participants.

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

7000

Participant exclusion criteria

Rich urban areas are not included in the randomized selection. These areas are not known to have major health problems.

Recruitment start date

01/09/2013

Recruitment end date

30/09/2013

Locations

Countries of recruitment

China

Trial participating centre

Shaanxi Normal University
China

Sponsor information

Organisation

Stanford University

Sponsor details

Stanford
CA
Stanford
94305
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

OneSight Research Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes