Color PerceptionNCT02464241
Evaluation of Different Color Vision Tests in Children
An observational study of Color Perception, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate which clinical colour vision assessment fits best for preschool children and school children. The investigators are going to investigate children with a known colour vision affecting ocular disease, as well as healthy children without colour vision deficiency. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Color Perception
- What is being tested?
- only examination
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Nov 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 80 children (girls and boys) at the age of 3-10 years without (40 children) or with (40 children) an ocular disease such as maculopathy, opticopathy or amblyopia will be included. Probands and patients are recruited from consultations at the eye clinic of the University hospital of Zürich. The ophthalmologic care is provided independently of the patient's decision whether to participate in the study or not. This decision is the own free will of the patient and his or her parents.
Who may be able to join
- Children at the age of 3-10 years old
- Informed Consent
- Patient group: reduced monocular visual acuity with maculopathy, opticopathy or amblyopia.
- Proband group: no disease with influence on the colour vision, age-related normal visual acuity
Who cannot join
- High anomalies of refraction (myopia < -6D, hyperopia > +4D)
- Status post eye surgery
- Medication with suspected influence on the visual perception
- Age below 3 years or beyond 10 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Color Vision Tests in Children: Comparison of Standardized and Computer-assisted Examination
The purpose of this study is to investigate which clinical colour vision assessment fits best for preschool children and school children. The investigators are going to investigate children with a known colour vision affecting ocular disease, as well as healthy children without colour vision deficiency. The goal is to compare the usability and validity of three different clinical tests for colour vision assessment which are already well established in adults but not yet in children.
Read the detailed description
Colour vision is an important part of the visual perception. There exist hereditary and acquired forms of colour vision deficiency. Hereditary forms affect 8% of males and 0.4% of females. Acquired forms can occur due to diseases which affect the retina, optic nerve or parts of the brain involved in colour vision such as the optic tract or visual cortex. Early diagnosis of colour vision deficiency is especially important in children to provide prompt aid through parents, teachers or other persons taking care. Moreover colour vision deficiency can be an early sign of beginning and progressive ocular diseases.
Colour vision assessment is part of standard clinical testing in ophthalmology. In children, colour vision assessment can be difficult, as most of the tests were developed for adults. The investigators are going to investigate the suitability of some of these tests for children. It is planned to investigate 40 children without colour vision deficiency and 40 children with a known colour vision deficiency. The data collection will take 1 year.
The study involves an ophthalmologic examination and the assessment of 3 different colour vision tests. All examinations are non-invasive, performed once and last in total about 1 to 1.5 hours. The visual acuity will be assessed by eye charts and refraction measurement followed by a slit lamp examination of the front sections of the eye and an optical examination of the eyeground. The three coulour vision tests are part of the standard repertoire of the Institute for ophthalmology of the University hospital of Zürich. Each colour vision test will be performed once as a test run and twice as a study examination. In the first test the child is asked to recognize known geometrical figures and pictures on charts. The second test involves the recognition of colored caps and the third test is a computer-assisted examination where the child should denote the position of a coloured area on the screen.
In the children with a known optical disease there will be performed additionally an optical coherence tomography to quantify the disease based morphological changes of the retinal layers. Therefore the pupils have to be dilated with the application of specific eye drops medication. This can lead to transient decrease of visual acuity for about 2-4 hours. The child should not drive a bicycle during this time interval. The principal of Optical coherence tomography (OCT) is similar to medical ultrasonics. However in OCT, there are used light waves instead of ultrasound waves, which allow an exact examination of the retinal cell layers.
All the examinations performed in this study are standardized procedures at the Institute of Ophthalmology of the University hospital of Zürich. No risks or harms are expected in relation with the planed examinations. No payment will be asked for the study related examinations. Neither for patients nor for their health insurances arise any additional costs related to the participation in this study.
- Conditions
- Color Perception
- Being tested
- only examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
only examinationOther
| Study group | Role | What they receive |
|---|---|---|
| normal control | normal control Receives: Other: only examination | |
| patients | patients with optic or macular pathology or amblyopia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of correct answers per child per test.
Measured: one test performed within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color PerceptionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Gerth-Kahlert, MD, Principal investigator, University Hospital Zurich, Division of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464241
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0340
- Status last verified
- Nov 2018
- First submitted
- 30 Mar 2015
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Vision Tests in Children: Comparison of Standardized and Computer-assisted Examination
- ClinicalTrials.gov ID
- NCT02464241
- Acronym / sponsor ID
- KEK-ZH-Nr. 2014-0340
- Conditions
- Color Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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 study is to investigate which clinical colour vision assessment fits best for preschool children and school children. The investigators are going to investigate children with a known colour vision affecting ocular disease, as well as healthy children without colour vision deficiency. The goal is to compare the usability and validity of three different clinical tests for colour vision assessment which are already well established in adults but not yet in children.
Detailed description
Colour vision is an important part of the visual perception. There exist hereditary and acquired forms of colour vision deficiency. Hereditary forms affect 8% of males and 0.4% of females. Acquired forms can occur due to diseases which affect the retina, optic nerve or parts of the brain involved in colour vision such as the optic tract or visual cortex. Early diagnosis of colour vision deficiency is especially important in children to provide prompt aid through parents, teachers or other persons taking care. Moreover colour vision deficiency can be an early sign of beginning and progressive ocular diseases.
Colour vision assessment is part of standard clinical testing in ophthalmology. In children, colour vision assessment can be difficult, as most of the tests were developed for adults. The investigators are going to investigate the suitability of some of these tests for children. It is planned to investigate 40 children without colour vision deficiency and 40 children with a known colour vision deficiency. The data collection will take 1 year.
The study involves an ophthalmologic examination and the assessment of 3 different colour vision tests. All examinations are non-invasive, performed once and last in total about 1 to 1.5 hours. The visual acuity will be assessed by eye charts and refraction measurement followed by a slit lamp examination of the front sections of the eye and an optical examination of the eyeground. The three coulour vision tests are part of the standard repertoire of the Institute for ophthalmology of the University hospital of Zürich. Each colour vision test will be performed once as a test run and twice as a study examination. In the first test the child is asked to recognize known geometrical figures and pictures on charts. The second test involves the recognition of colored caps and the third test is a computer-assisted examination where the child should denote the position of a coloured area on the screen.
In the children with a known optical disease there will be performed additionally an optical coherence tomography to quantify the disease based morphological changes of the retinal layers. Therefore the pupils have to be dilated with the application of specific eye drops medication. This can lead to transient decrease of visual acuity for about 2-4 hours. The child should not drive a bicycle during this time interval. The principal of Optical coherence tomography (OCT) is similar to medical ultrasonics. However in OCT, there are used light waves instead of ultrasound waves, which allow an exact examination of the retinal cell layers.
All the examinations performed in this study are standardized procedures at the Institute of Ophthalmology of the University hospital of Zürich. No risks or harms are expected in relation with the planed examinations. No payment will be asked for the study related examinations. Neither for patients nor for their health insurances arise any additional costs related to the participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal control | – | Other: only examinationnormal control |
| patients | – | –patients with optic or macular pathology or amblyopia |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 80 children (girls and boys) at the age of 3-10 years without (40 children) or with (40 children) an ocular disease such as maculopathy, opticopathy or amblyopia will be included. Probands and patients are recruited from consultations at the eye clinic of the University hospital of Zürich. The ophthalmologic care is provided independently of the patient's decision whether to participate in the study or not. This decision is the own free will of the patient and his or her parents.
Key inclusion criteria (4 listed)
- Children at the age of 3-10 years old
- Informed Consent
- Patient group: reduced monocular visual acuity with maculopathy, opticopathy or amblyopia.
- Proband group: no disease with influence on the colour vision, age-related normal visual acuity
Key exclusion criteria (4 listed)
- High anomalies of refraction (myopia < -6D, hyperopia > +4D)
- Status post eye surgery
- Medication with suspected influence on the visual perception
- Age below 3 years or beyond 10 years.
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 |
|---|---|---|
| only examination | Other | normal control |
Primary outcome
Percentage of correct answers per child per test.
Time frame: one test performed within 1 year
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 26 Nov 2018.
Related trials for Color Perception
RecruitingObservational study
Perception, Sensation, Cognition and Action in Humans
Normal Physiology
RecruitingObservational study
Visual Perception, Binocular Rivalry, and Fatigue-Related Individual Differences in Colour and Illumination Judgement
Colour Perception, Color Perception
Recruiting
Study of Visual Perception Phenomena: Phosphene Mapping Induced by TMS and Its Relationship With Eye Movements
Visual Snow Syndrome, Color Blindness
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.
Christina Gerth-Kahlert, MD principal investigator
University Hospital Zurich, Division of Ophthalmology
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 Color Perception, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 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 Switzerland. 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?
Percentage of correct answers per child per test. (time frame: one test performed within 1 year). 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 26 Nov 2018.