NCT00477620

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 23, 2009

Status Verified

February 1, 2009

Enrollment Period

4.5 years

First QC Date

May 23, 2007

Last Update Submit

February 19, 2009

Conditions

Myopia

Keywords

MyopiaPrevention

Interventions

Wearing of reading glasses during prolonged near workBEHAVIORAL

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Emmetropia

You may not qualify if:

  • Ametropia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Alexaner Reis, PD Dr. med.

    Augenwerk Liechtenstein

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

April 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 23, 2009

Record last verified: 2009-02