NCT03750630

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 14, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

November 23, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

November 13, 2018

Last Update Submit

November 20, 2018

Conditions

Vision Status

Keywords

vision, children, adolescent

Outcome Measures

Primary Outcomes (1)

  • Refractive status

    Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.

    1 day

Secondary Outcomes (6)

  • Axial length

    1 day

  • Intraocular pressure

    1 day

  • Corneal thickness

    1 day

  • Fundus examination

    1 day

  • Serious and non-Serious Adverse Events

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Students with age between 3 to 18 years old

You may qualify if:

  • \- Students with age between 3 to 18 years old

You may not qualify if:

  • Students have any special ocular disease.
  • non-compliance with screening protocol
  • orthokeratology user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Central Study Contacts

I-Jong Wang

CONTACT

886-2-23123456ijong@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 23, 2018

Study Start

April 14, 2016

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

November 23, 2018

Record last verified: 2018-03

Locations

TW(1)