- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150421
Impact of Electronic Devices on Myopia Development and Progression
Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren
Study Overview
Status
Conditions
Detailed Description
With the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. Parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology.
This is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren.
The schools will introduce e-books to their students in some classes. Signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. Eye examination and data collection will be conducted in primary school campus. The children from two local primary schools in same grade will be assigned into two groups by their schools. One group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). Their refractive errors, axial length (AXL) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Hong Kong, China
- School of Optometry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Chinese
- study local primary schools
Exclusion Criteria:
- with any ocular diseases and binocular anomalies might affect visual functions or refractive development
- with history of eye surgery
- have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-K, eyedrops (e.g. atropine)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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e-book
study the course materials by using e-book
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in refractive errors
Time Frame: 2 years
|
cycloplegic autorefraction
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in axial length
Time Frame: 2 years
|
measured by the Zeiss IOLMaster after cycloplegia
|
2 years
|
Keratometric changes
Time Frame: 2 years
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phoria at distance and near
Time Frame: every 6-month
|
Howell phoria cards
|
every 6-month
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carly SY Lam, Professor, School of Optometry, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TWGHs
- TWGHs2013 (Other Grant/Funding Number: Tung Wah Group of Hospitals)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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