CAD Test; Children's Vision; Colour Assessment; Colour Vision; TurkeyNCT04048499
Prevalence and Severity of Colour Vision Deficiency Among Turkish Children
An observational study of CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey
- What is being tested?
- the Colour Assessment and Diagnosis (CAD) test
- Type of treatment
- Medical device
- How many people
- 1,374 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Mar 2019
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: A total of 1374 children, aged 6-16 years, who attended the ophthalmology department at the Istanbul Medipol University were included in the study.
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- the Colour Assessment and Diagnosis (CAD) test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Colour Assessment and Diagnosis (CAD) testDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: january 2018-march 2019
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
Measured: january 2018-march 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Jan 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD Test; Children's Vision; Colour Assessment; Colour Vision; TurkeyStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda Dikkaya, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048499
- Sponsor's protocol ID
- 425
- Status last verified
- Aug 2019
- First submitted
- 6 Aug 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Severity of Colour Vision Deficiency Among Turkish Children
- ClinicalTrials.gov ID
- NCT04048499
- Acronym / sponsor ID
- 425
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,374 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 7 Aug 2019 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- A total of 1374 children, aged 6-16 years, who attended the ophthalmology department at the Istanbul Medipol University were included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the Colour Assessment and Diagnosis (CAD) testThe 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 | Device | – |
Primary outcome
Prevalence and Severity of Colour Vision Deficiency among Turkish Children
Time frame: 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.
the usability of the Colour Assessment and Diagnosis (CAD) test in children
Time frame: january 2018-march 2019
number of children who were cooperative and carried out the full CAD test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 CAD Test; Children's Vision; Colour Assessment; Colour Vision; Turkey, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 9 Aug 2019. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Severity of Colour Vision Deficiency among Turkish Children (time frame: january 2018-march 2019). The study lists 2 primary outcomes in all. 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 9 Aug 2019.