A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan

Vision Status Clinical Trial

Official title:

A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750630
• Other study ID #: 201510078RINB
• Status: Recruiting
• Start date: April 14, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: National Taiwan University Hospital
• Contact: I-Jong Wang
• Phone: 886-2-23123456
• Email: ijong[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan.

Description:

The purpose of this research project is to develop a vision surveillance system, in order of understanding the vision health status of children and adolescents in Taiwan. It can serve as a basis for the government to establish a nationwide vision surveillance system, invest research resources, and make national policies.

This research project also classified the urbanization of sampling school as high, medium and low based on the location of school.This research project explored and analyzed the health status of myopic schoolchildren and associated factors such as families, genetics, school environment, living environment and behaviors among north, south, west and east regions of Taiwan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Students with age between 3 to 18 years old

Exclusion Criteria:

1. Students have any special ocular disease.

2. non-compliance with screening protocol

3. orthokeratology user

Related Conditions & MeSH terms

• Vision Status

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractive status	Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.	1 day
Secondary	Axial length	The axial length is the distance between the anterior surface of the cornea and the fovea and is the primary determinant of non-syndromic myopia. In this research project, investigators measure the axial length in children and adolescents by A-scan.	1 day
Secondary	Intraocular pressure	Intraocular pressure is the pressure created by the continual renewal of fluids within the eye. In this research project, investigators measure the intraocular pressure in children and adolescents by Icare Tonometer.	1 day
Secondary	Corneal thickness	Corneal thickness is an important factor in accurately diagnosing eye pressure. In this report project, investigators measure the corneal thickness in children and adolescents by A-scan.	1 day
Secondary	Fundus examination	The fundus is the portion of the inner eye that can be seen during an eye examination by looking through the pupil. In this research project, investigators perform the fundus examination in children and adolescents by ophthalmoscope.	1 day
Secondary	Serious and non-Serious Adverse Events	The adverse events in children and adolescents	1 day
Secondary	Questionnaire	Associated factors such as families, genetics, school environment, living environment and behaviors	1 day