Text Size

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
History of Changes
  Purpose

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 Intervention
Myopia
 Behavioral: Wearing of reading glasses during prolonged near work

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Myopia Acquisition and Prevention in a Randomised Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Freiburg:

Study Start Date: April 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Emmetropia

Exclusion Criteria:

  • Ametropia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477620

Sponsors and Collaborators
University Hospital Freiburg
Investigators
Study Chair: Alexaner Reis, PD Dr. med. Augenwerk Liechtenstein
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00477620     History of Changes
Other Study ID Numbers: FR-2005-01-01
Study First Received: May 23, 2007
Last Updated: February 19, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Freiburg:
Myopia
Prevention

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013