NCT02903628

Brief Summary

The purpose of this study is to determine whether Eye Health Intervention can obviously reduce and delay myopia onset and development and improved the awareness rate of knowledge apparently .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,517

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2.7 years

First QC Date

September 4, 2016

Last Update Submit

September 12, 2016

Conditions

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Myopia

    every 6 months, total 3 years

Secondary Outcomes (2)

  • health of eyes knowledge

    every 6 months, total 3 years, questionnair

  • health of eyes behavior

    every 6 months, total 3 years, questionnaire

Study Arms (1)

eye health education

EXPERIMENTAL
Behavioral: eye health education

Interventions

give a lecture and issue knowledge manual for children and parents ,6 months once , 2.5 years

eye health education

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • primary 1-3 grade students

You may not qualify if:

  • ocular inflammation
  • eye injury
  • dysgnosia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Leo SW, Young TL. An evidence-based update on myopia and interventions to retard its progression. J AAPOS. 2011 Apr;15(2):181-9. doi: 10.1016/j.jaapos.2010.09.020.

  • Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.

  • Schaeffel F. [Myopia update 2011]. Klin Monbl Augenheilkd. 2011 Sep;228(9):754-61. doi: 10.1055/s-0031-1281584. Epub 2011 Jul 27. German.

  • Adler D, Millodot M. The possible effect of undercorrection on myopic progression in children. Clin Exp Optom. 2006 Sep;89(5):315-21. doi: 10.1111/j.1444-0938.2006.00055.x.

  • Seet B, Wong TY, Tan DT, Saw SM, Balakrishnan V, Lee LK, Lim AS. Myopia in Singapore: taking a public health approach. Br J Ophthalmol. 2001 May;85(5):521-6. doi: 10.1136/bjo.85.5.521. No abstract available.

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • yan yan chen, master

    Wenzhou Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-president, Nurse, Principal Investigator

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 16, 2016

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

September 16, 2016

Record last verified: 2016-09