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Study of Myopia Acquisition and Prevention (SMART)

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00477620
First received: May 23, 2007
Last updated: February 19, 2009
Last verified: February 2009

May 23, 2007
February 19, 2009
April 2004
October 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00477620 on ClinicalTrials.gov Archive Site
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Study of Myopia Acquisition and Prevention
Study of Myopia Acquisition and Prevention in a Randomised Trial

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myopia
Behavioral: Wearing of reading glasses during prolonged near work
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Emmetropia

Exclusion Criteria:

  • Ametropia
Both
7 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00477620
FR-2005-01-01
No
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University Hospital Freiburg
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Study Chair: Alexaner Reis, PD Dr. med. Augenwerk Liechtenstein
University Hospital Freiburg
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP