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SMART: Study of Myopia Acquisition and Prevention

Sponsor
University Hospital Freiburg (Other)
Overall Status
Completed
CT.gov ID
NCT00477620
Collaborator
(none)
54
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Wearing of reading glasses during prolonged near work
 N/A

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Study of Myopia Acquisition and Prevention in a Randomised Trial
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Emmetropia
    Exclusion Criteria:
    • Ametropia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital Freiburg

    Investigators

    • Study Chair: Alexaner Reis, PD Dr. med., Augenwerk Liechtenstein

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00477620
    Other Study ID Numbers:
    • FR-2005-01-01
    First Posted:
    May 24, 2007
    Last Update Posted:
    Feb 23, 2009
    Last Verified:
    Feb 1, 2009
    Keywords provided by , ,
    Myopia
    Prevention
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Feb 23, 2009