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Impact of Electronic Devices on Myopia Development and Progression

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT02150421
Collaborator
Tung Wah Group of Hospitals (Other)
201
Enrollment
1
Location
29
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    201 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Impact of School Curriculum Engaging Electronic Devices on Myopia Development and Progression in Primary Schoolchildren
    Study Start Date :
    Sep 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Feb 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    e-book

    study the course materials by using e-book

    Outcome Measures

    Primary Outcome Measures

    1. Changes in refractive errors [2 years]

      cycloplegic autorefraction

    Secondary Outcome Measures

    1. changes in axial length [2 years]

      measured by the Zeiss IOLMaster after cycloplegia

    2. Keratometric changes [2 years]

    Other Outcome Measures

    1. Phoria at distance and near [every 6-month]

      Howell phoria cards

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 School of Optometry Hong Kong China

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University
    • Tung Wah Group of Hospitals

    Investigators

    • Principal Investigator: Carly SY Lam, Professor, School of Optometry, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carly Lam, Professor, The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT02150421
    Other Study ID Numbers:
    • TWGHs
    • TWGHs2013
    First Posted:
    May 29, 2014
    Last Update Posted:
    Jun 22, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Jun 22, 2016