Vision StatusNCT03750630
A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan
An observational study of Vision Status, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Vision Status
- How many people
- 10,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Apr 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Students with age between 3 to 18 years old
Who may be able to join
- Students with age between 3 to 18 years old
Who cannot join
- Students have any special ocular disease.
- non-compliance with screening protocol
- orthokeratology user
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan
I-Jong Wang, 886-2-23123456 ext. 65729, ijong@ntu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Vision Status
- Keywords
- vision, children, adolescent
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive status
Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.
Measured: 1 day
Secondary outcomes (6)
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Serious and non-Serious Adverse Events
The adverse events in children and adolescents
Measured: 1 day
Questionnaire
Associated factors such as families, genetics, school environment, living environment and behaviors
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start14 Apr 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision StatusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750630
- Sponsor's protocol ID
- 201510078RINB
- Status last verified
- Mar 2018
- First submitted
- 13 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Survey to Establish Vision Health Surveillance Indicators for Children and Adolescent in Taiwan
- ClinicalTrials.gov ID
- NCT03750630
- Acronym / sponsor ID
- 201510078RINB
- Conditions
- Vision Status
- Keywords
- vision, children, adolescent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Students with age between 3 to 18 years old
Key inclusion criteria (1 listed)
- Students with age between 3 to 18 years old
Key exclusion criteria (3 listed)
- Students have any special ocular disease.
- non-compliance with screening protocol
- orthokeratology user
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Refractive status
Time frame: 1 day
Cycloplegic spherical refraction measured by auto-refractometer (Diopter) in children and adolescents.
6 secondary outcomes
Axial length
Time frame: 1 day
Intraocular pressure
Time frame: 1 day
Corneal thickness
Time frame: 1 day
Fundus examination
Time frame: 1 day
Serious and non-Serious Adverse Events
Time frame: 1 day
Questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
Related trials for Vision Status
Not yet recruitingObservational study
Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA)
Ischemia and Non-obstructive Coronary Arteries
RecruitingObservational study
Visual Frailty in Ageing
Frailty, Age-Related Macular Degeneration
Not yet recruiting
Hydration Status and Ocular Parameters Study
Hydration Status, Macular Thickness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vision Status, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Jong Wang (886-2-23123456 ext. 65729, ijong@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive status (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.