Prevalence and Severity of Colour Vision Deficiency Among Turkish Children

• Sponsor: Medipol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04048499
• Collaborator: (none)
• Enrollment: 1,374
• Location: 1
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 98.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey	Device: the Colour Assessment and Diagnosis (CAD) test

Study Design

• Study Type: Observational
• Actual Enrollment: 1374 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Prevalence and Severity of Colour Vision Deficiency Among Turkish Children
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 1, 2019

Outcome Measures

Primary Outcome Measures

1. Prevalence and Severity of Colour Vision Deficiency among Turkish Children [january 2018-march 2019]

   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.

2. the usability of the Colour Assessment and Diagnosis (CAD) test in children [january 2018-march 2019]

   number of children who were cooperative and carried out the full CAD test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University	Istanbul		Turkey

Sponsors and Collaborators

• Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Funda Dikkaya, asist proffesor, Medipol University
• ClinicalTrials.gov Identifier: NCT04048499
• Other Study ID Numbers: 425
• First Posted: Aug 7, 2019
• Last Update Posted: Aug 9, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Color Vision Defects

Study Results

No Results Posted as of Aug 9, 2019