The Model Building and Empirical Research of Eye Health Interventions for Children

Myopia Clinical Trial

Official title:

Vice-president, Nurse, Principal Investigator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903628
• Other study ID #: 2012C3301
• Status: Completed
• Phase: N/A
• First received: September 4, 2016
• Last updated: September 12, 2016
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2016
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Science Technoloy Department of Zhejiang Province
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1517
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• primary 1-3 grade students

Exclusion Criteria:

• ocular inflammation

• eye injury

• dysgnosia

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Myopia

Intervention

Behavioral:
• eye health education
give a lecture and issue knowledge manual for children and parents ,6 months once , 2.5 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

References & Publications (5)

Adler D, Millodot M. The possible effect of undercorrection on myopic progression in children. Clin Exp Optom. 2006 Sep;89(5):315-21. — View Citation

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Myopia		every 6 months, total 3 years	No
Secondary	health of eyes knowledge		every 6 months, total 3 years, questionnair	No
Secondary	health of eyes behavior		every 6 months, total 3 years, questionnaire	No