NCT00627874

Brief Summary

The purpose of this study is to assess whether a short-term imposed myopic defocus is effective in preventing the development and progression of juvenile-onset myopia in Chinese children.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 20, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 4, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

2 years

First QC Date

February 20, 2008

Last Update Submit

February 20, 2009

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Axial Length of eyes

    Annual

Secondary Outcomes (1)

  • Autorefraction

    Annual

Study Arms (2)

1

EXPERIMENTAL

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

Device: +3D Lenses

2

NO INTERVENTION

Interventions

+3D LensesDEVICE

wear +3D glasses for 30 minutes per day and engage in activities which require vision at more than 1m

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All children in the selected class are enrolled

You may not qualify if:

  • Hyperopia \> +2.0 D
  • High myopia \> -6.0 D
  • Astigmatism\> 1.5 D
  • Anisometropia \> 1.5 D
  • Strabismus and amblyopia
  • Any ocular, systemic, or neurodevelopmental conditions that could influence refractive development
  • Chronic medication use that might affect myopia progression or visual acuity
  • Already receiving other treatment for progressing myopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Mingguang He, PhD, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

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

February 20, 2008

First Posted

March 4, 2008

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 24, 2009

Record last verified: 2009-02