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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04048499
Other study ID # 425
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 1, 2019

Study information

Verified date August 2019
Source Medipol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the usability of the Colour Assessment and Diagnosis (CAD) test in children. To determine the prevalence of colour vision deficiency (CVD) among Turkish children, to identify the class of deficiency and to quanify severity of loss.


Recruitment information / eligibility

Status Completed
Enrollment 1374
Est. completion date March 1, 2019
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: children with aged 6-16 years, who attended the ophthalmology department at the Istanbul Medipol University -

Exclusion Criteria:Children with known or current evidence of ocular pathology (other than refractive errors), with history of long term use of medication, previous ocular surgery and those with chronic systemic diseases were excluded from the study

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
the Colour Assessment and Diagnosis (CAD) test
The CAD test (City Occupational Ltd, London, UK) measures the severity of red-green and yellow-blue colour vision loss according to red-green and yellow-blue thresholds which are expressed in CAD units and diagnoses accurately the subject's class of colour vision

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence and Severity of Colour Vision Deficiency among Turkish Children number of children with colour vision deficiency (CVD) among Turkish children who attend to the clinic in a period o time, number of children in each class of deficiency (protan, deutan) and number of children in each category according to severity. january 2018-march 2019
Primary the usability of the Colour Assessment and Diagnosis (CAD) test in children number of children who were cooperative and carried out the full CAD test january 2018-march 2019