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

• Conditions: Vision Status

• Registration Number: NCT03750630
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-04-14
• Status Verified: 2018-03
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-20
• Last Update Submitted: 2018-11-20
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-23
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Students with age between 3 to 18 years old

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Exclusion Criteria

1. Students have any special ocular disease.
2. non-compliance with screening protocol
3. orthokeratology user

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Refractive status	1 day	Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.

Secondary Outcome Measures

Name	Time	Method
Serious and non-Serious Adverse Events	1 day	The adverse events in children and adolescents
Corneal thickness	1 day	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.
Fundus examination	1 day	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.
Questionnaire	1 day	Associated factors such as families, genetics, school environment, living environment and behaviors
Axial length	1 day	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.
Intraocular pressure	1 day	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan, Taiwan