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

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ClinicalTrials.gov Identifier: NCT03750630
Recruitment Status : Unknown
Verified March 2018 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 23, 2018
Last Update Posted : November 23, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease
Vision Status

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 Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan
Actual Study Start Date : April 14, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Refractive status [ Time Frame: 1 day ]
    Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.


Secondary Outcome Measures :
  1. Axial length [ Time Frame: 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.

  2. Intraocular pressure [ Time Frame: 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.

  3. Corneal thickness [ Time Frame: 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.

  4. Fundus examination [ Time Frame: 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.

  5. Serious and non-Serious Adverse Events [ Time Frame: 1 day ]
    The adverse events in children and adolescents

  6. Questionnaire [ Time Frame: 1 day ]
    Associated factors such as families, genetics, school environment, living environment and behaviors


Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Students with age between 3 to 18 years old
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750630


Contacts
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Contact: I-Jong Wang 886-2-23123456 ext 65729 ijong@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, Taiwan
Contact: I-Jong Wang    886-2-23123456 ext 65729    ijong@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03750630    
Other Study ID Numbers: 201510078RINB
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
vision, children, adolescent