NCT02464241

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

3.6 years

First QC Date

March 30, 2015

Last Update Submit

November 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of correct answers per child per test.

    one test performed within 1 year

Study Arms (2)

normal control

normal control

Other: only examination

patients

patients with optic or macular pathology or amblyopia

Interventions

normal control

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

Inclusion-Criteria: * 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 Exclusion-Criteria: * 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Study Officials

  • Christina Gerth-Kahlert, MD

    University Hospital Zurich, Division of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

June 8, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations