Seeing is learning: vision care for middle school students in China's rural areas
| ISRCTN | ISRCTN17141957 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17141957 |
| Secondary identifying numbers | 28345 |
- Submission date
- 13/05/2015
- Registration date
- 27/05/2015
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
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
Contact information
Public
Stanford University
Stanford
94305
United States of America
Study information
| Study design | Interventional cluster-randomized multicenter controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Treatment |
| Scientific title | Seeing is learning: vision care for middle school students in China's rural areas |
| 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(s) | Stanford University, 30/09/2014, Protocol ID: 28345 |
| 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 |
| Primary outcome measure | 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 study start date | 01/09/2013 |
| Overall study end date | 31/12/2015 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 13 Years |
| Sex | Both |
| Target number of participants | 7000 |
| Total final enrolment | 995 |
| 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 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
Study participating centre
China
Sponsor information
University/education
Stanford, CA
Stanford
94305
United States of America
"ROR" |
https://ror.org/00f54p054 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/09/2020 | 23/10/2020 | Yes | No |
Editorial Notes
23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
