NCT04060238

Brief Summary

The aim of the offered project is to investigate the influence of protanopia (red blindness) or protanomaly (red vision weakness) on the recognizability of red brake lights with the help of a test person study. From this, estimates of the influence of protanopia or protanomaly on driving ability are to be derived. If a relevant influence can be demonstrated in the study, recommendations for action for the legislator will be made. Translated with www.DeepL.com/Translator

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

August 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 31, 2020

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

August 13, 2019

Last Update Submit

March 28, 2020

Conditions

Keywords

protanopiataillightbrake lightdifferential luminance sensitivitycontrast sensitivitycolour visioncolour vision defectperimetrysemi-automated kinetic perimetrytrafficmotoristreaction time

Outcome Measures

Primary Outcomes (1)

  • Contrast sensitivity (I)

    Contrast sensitivity between taillight and brake light under two luminance conditions

    within one year

Secondary Outcomes (5)

  • Reaction time

    within one year

  • Contrast sensitivity (II)

    within one year

  • Reaction time (II)

    within one year

  • Perimetric extent of horizontal meridian

    within one year

  • Loss of brightness sensation during anomaloscopic exam

    within one year

Study Arms (2)

Normal colour vision

Normal trichromopsia

Diagnostic Test: Anomaloscope (colour vision test)

Inherited red blindness

Protanopia

Diagnostic Test: Anomaloscope (colour vision test)

Interventions

The Heidelberg Multi Colour (HMC) Anolmaloscope (Oculus Inc., Dutenhofen/FRG) is used to differentiate between normal controls (normal trichromatopsia) and test subjects with protanopia ("inherited red colour blindness")

Inherited red blindnessNormal colour vision

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale subjects only
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ophthalmologically normal (male) subjects OR (male) subjects with (inherited) protanopia (red blindness)

You may qualify if:

  • informed consent
  • male
  • age (greater or equal) 18 years

You may not qualify if:

  • binocular (high contrast) distant visual acuity worse than 0.8 (16/20)
  • spherical ametropia exceeding 8 dpt
  • cylindrical ametropia exceeding 2.5 dpt
  • manifest strabismus (squint) with diplopia
  • relative afferent pupillary defect exceeding 0.3 log units
  • anamnestic (patient history) OR morphological (slit lamp --\> anterior segment, ophthalmoscope --\> retina) clue/indicator for a ophthalmologically relevant affection of the eye OR the visual pathway
  • S.p. severe ocular trauma
  • Current OR s.p. severe intraocular inflammation
  • S.p. intraocular surgery within the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulrich SCHIEFER

Aalen, Deutschland, 73430, Germany

Location

MeSH Terms

Conditions

Color Vision Defects

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesCone DystrophyEye Diseases, HereditaryEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulrich Schiefer, MD

    Aalen University of Applied Sciences

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 19, 2019

Study Start

January 7, 2020

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

March 31, 2020

Record last verified: 2019-06

Locations