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Study of Myopia Acquisition and Prevention (SMART)

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearing of reading glasses during prolonged near work
Sponsored by
University Hospital Freiburg
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Myopia, Prevention

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Emmetropia

Exclusion Criteria:

  • Ametropia

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2007
    Last Updated
    February 19, 2009
    Sponsor
    University Hospital Freiburg
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00477620
    Brief Title
    Study of Myopia Acquisition and Prevention
    Acronym
    SMART
    Official Title
    Study of Myopia Acquisition and Prevention in a Randomised Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital Freiburg

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose: To determine whether the use of reading glasses blocks the near work mediated increased incidence of myopia in healthy school children. Methods: SMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the Principality of Liechtenstein. They were randomly assigned to either the control group (n=52) or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome measure was progression towards myopia as determined by autorefraction after cycloplegia. The secondary outcome measure was change in biometry measurements of corneal curvature, axial length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using partial coherence interferometry.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Wearing of reading glasses during prolonged near work

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Emmetropia Exclusion Criteria: Ametropia
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexaner Reis, PD Dr. med.
    Organizational Affiliation
    Augenwerk Liechtenstein
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of Myopia Acquisition and Prevention

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