Study of Myopia Acquisition and Prevention

Myopia Clinical Trial

— SMART  

Official title:

Study of Myopia Acquisition and Prevention in a Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477620
• Other study ID #: FR-2005-01-01
• Status: Completed
• Phase: N/A
• First received: May 23, 2007
• Last updated: February 19, 2009
• Start date: April 2004
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 9 Years

Eligibility

Inclusion Criteria:

• Emmetropia

Exclusion Criteria:

• Ametropia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Behavioral:
• Wearing of reading glasses during prolonged near work

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg