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The Model Building and Empirical Research of Eye Health Interventions for Children

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eye health education
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring myopia

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • primary 1-3 grade students

Exclusion Criteria:

  • ocular inflammation
  • eye injury
  • dysgnosia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    eye health education

    Arm Description

    Outcomes

    Primary Outcome Measures

    Prevalence of Myopia

    Secondary Outcome Measures

    health of eyes knowledge
    health of eyes behavior

    Full Information

    First Posted
    September 4, 2016
    Last Updated
    September 12, 2016
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02903628
    Brief Title
    The Model Building and Empirical Research of Eye Health Interventions for Children
    Official Title
    Vice-president, Nurse, Principal Investigator
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wenzhou Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether Eye Health Intervention can obviously reduce and delay myopia onset and development and improved the awareness rate of knowledge apparently .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia
    Keywords
    myopia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1517 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    eye health education
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    eye health education
    Intervention Description
    give a lecture and issue knowledge manual for children and parents ,6 months once , 2.5 years
    Primary Outcome Measure Information:
    Title
    Prevalence of Myopia
    Time Frame
    every 6 months, total 3 years
    Secondary Outcome Measure Information:
    Title
    health of eyes knowledge
    Time Frame
    every 6 months, total 3 years, questionnair
    Title
    health of eyes behavior
    Time Frame
    every 6 months, total 3 years, questionnaire

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: primary 1-3 grade students Exclusion Criteria: ocular inflammation eye injury dysgnosia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yan yan chen, master
    Organizational Affiliation
    Wenzhou Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    21596297
    Citation
    Leo SW, Young TL. An evidence-based update on myopia and interventions to retard its progression. J AAPOS. 2011 Apr;15(2):181-9. doi: 10.1016/j.jaapos.2010.09.020.
    Results Reference
    result
    PubMed Identifier
    11874738
    Citation
    Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.
    Results Reference
    result
    PubMed Identifier
    21796575
    Citation
    Schaeffel F. [Myopia update 2011]. Klin Monbl Augenheilkd. 2011 Sep;228(9):754-61. doi: 10.1055/s-0031-1281584. Epub 2011 Jul 27. German.
    Results Reference
    result
    PubMed Identifier
    16907670
    Citation
    Adler D, Millodot M. The possible effect of undercorrection on myopic progression in children. Clin Exp Optom. 2006 Sep;89(5):315-21. doi: 10.1111/j.1444-0938.2006.00055.x.
    Results Reference
    result
    PubMed Identifier
    11316705
    Citation
    Seet B, Wong TY, Tan DT, Saw SM, Balakrishnan V, Lee LK, Lim AS. Myopia in Singapore: taking a public health approach. Br J Ophthalmol. 2001 May;85(5):521-6. doi: 10.1136/bjo.85.5.521. No abstract available.
    Results Reference
    result

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    The Model Building and Empirical Research of Eye Health Interventions for Children

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