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Trial of Myopia Prevention Using +3D Lenses (PLS)

Primary Purpose

Myopia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
+3D Lenses
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All children in the selected class are enrolled

Exclusion Criteria:

  • Hyperopia > +2.0 D
  • High myopia > -6.0 D
  • Astigmatism> 1.5 D
  • Anisometropia > 1.5 D
  • Strabismus and amblyopia
  • Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
  • Chronic medication use that might affect myopia progression or visual acuity
  • Already receiving other treatment for progressing myopia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

    Outcomes

    Primary Outcome Measures

    Axial Length of eyes

    Secondary Outcome Measures

    Autorefraction

    Full Information

    First Posted
    February 20, 2008
    Last Updated
    February 20, 2009
    Sponsor
    Sun Yat-sen University
    Collaborators
    Australian National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00627874
    Brief Title
    Trial of Myopia Prevention Using +3D Lenses
    Acronym
    PLS
    Official Title
    A Randomised, Controlled Trial of Prevention of Juvenile-Onset Myopia in Chinese Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    April 2012 (Anticipated)
    Study Completion Date
    April 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sun Yat-sen University
    Collaborators
    Australian National University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.
    Detailed Description
    To determine if +3D lenses wearing for half an hour everyday prevents the development and progression of myopia in school children. To identify ocular parameters and risk factors at baseline associated with development and progression of myopia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
    Arm Title
    2
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    +3D Lenses
    Intervention Description
    wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m
    Primary Outcome Measure Information:
    Title
    Axial Length of eyes
    Time Frame
    Annual
    Secondary Outcome Measure Information:
    Title
    Autorefraction
    Time Frame
    Annual

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All children in the selected class are enrolled Exclusion Criteria: Hyperopia > +2.0 D High myopia > -6.0 D Astigmatism> 1.5 D Anisometropia > 1.5 D Strabismus and amblyopia Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development Chronic medication use that might affect myopia progression or visual acuity Already receiving other treatment for progressing myopia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mingguang He, PhD, MD
    Organizational Affiliation
    Zhongshan Ophthalmic Center, Sun Yat-sen University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Trial of Myopia Prevention Using +3D Lenses

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