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CompletedNCT04060238ProLightUpdated Mar 31, 2020

Effect of Protanopia on the Brightness Perception of Brake Lights

An observational study in Color Blindness, Red and Reaction Time, sponsored by Aalen University. Completed at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.

Sponsored by Aalen University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
16
Ages
18 Years and older
Sex
Male
01

Study 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

Read the detailed description

Protanopia is an x-chromosomal inherited cone pigment disorder that related to the red cone,i.e. the L-cone function completely fails. The prevalence of protanopia in the male population is 1%. An incomplete impairment of the L-cone is called protanomaly. The prevalence here is also in 1% of the male population.

In comparison to persons with normal vision red objects appear darker for persons with missing or functionally limited L-cones. This is particularly critical in road traffic, where red is used as a signal colour, for example in traffic lights or brake lights is used.

The scientific questions that need to be investigated are as follows:

  1. At which contrast threshold (relative brightness) does a proband with protanopia recognize a brake light compared to a normal person?
  2. If the luminance determined is above the contrast threshold, what influence does the excess of the contrast or the determined luminance have on the reaction time?
  3. Are there differences with regard to the technology used in the brake light (incandescent lamp or LED)?

For this purpose, a representative set of combination rear lamps, focusing on stoplight, taillight (and of the elevated brake light) in a static situation is created. The test setup is based on a driving pursuit scenario. The test person is positioned at a relevant distance to the combination of rear lamps.

To determine the threshold contrast, an algorithm is developed to control the relative brightness of the brake lights and integrated into the test sequence control. In addition, a method for automated determining of the related reaction time is implemented.

Two taillight technologies (incandescent lamp and LED) are examined at both ambient brightness levels: (i) "bright", i.e. photopic luminance level (Lu >> 10 cd/m2) and (ii) "dark", i.e. mesopic luminance level (Lu \< 10 cd/m2).

A comprehensive ophthalmological/optical examination (including visual acuity, ocular alignment, ocular motility, assessment of the leading eye, testing of the efferent and afferent pupillary system and biomicroscopic inspection of the anterior and posterior segments of the eye) is carried out. Comprehensive colour vision testing it performed with the HMC anomaloscope, Oculus Inc., Dutenhofen/FRG, including assessment of the loss of brightness sensation during anomaloscopic exam with max. red. stimulus . In addition, standardized semi-automated kinetic perimetry (SKP) along the horizontal meridian with an automated perimeter (Octopus 900, Haag-Streit Inc., Koeniz/CH) is performed. The ratio of the horizontal extent ("diameter") obtained with both, red vs. white stimuli, is measured and taken as a clinical parameter for quantifying the magnitude of the individual "protan colour vision deficiency".

To illustrate the worst-case scenario, this study is limited to protanopic patients. It is intended as a pure comparative study between a "protanopic" patient group and a "normal vision" control group. The protanopic test subjects and the control subjects are matched with regard to gender and age.

This study is carried out in a "within-subject design", i.e. all test persons go through all situations. In order to minimize sequence effects, the related test conditions are randomized.

02

Conditions studied

  • Color Blindness, Red
  • Reaction Time

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Keywords

  • protanopia
  • taillight
  • brake light
  • differential luminance sensitivity
  • contrast sensitivity
  • colour vision
  • colour vision defect
  • perimetry
  • semi-automated kinetic perimetry
  • traffic
  • motorist
  • reaction time
03

In context

Color Vision Defects

62 studies on the registry are indexed under Color Vision Defects; 11 are open to participants now.

This study's enrollment of 16 is below the median of 103 across 15 observational studies indexed under Color Vision Defects.

Browse Color Vision Defects studies →

Lead sponsor

Aalen University is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • male
  • age (greater or equal) 18 years

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No

Groups and cohorts

  • Normal colour vision

    Normal trichromopsia

    Diagnostic Test: Anomaloscope (colour vision test)

  • Inherited red blindness

    Protanopia

    Diagnostic Test: Anomaloscope (colour vision test)

Interventions

  • Diagnostic testAnomaloscope (colour vision test)

    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")

06

What researchers measure

Primary outcomes

  1. Contrast sensitivity (I)

    Contrast sensitivity between taillight and brake light under two luminance conditions

    Time frame: within one year

Secondary outcomes

  1. Reaction time

    Time span within the onset of the brake light and the reaction of the tested subject

    Time frame: within one year

  2. Contrast sensitivity (II)

    taillight technology: incandescent lamp vs. light emitting diode (LED)

    Time frame: within one year

  3. Reaction time (II)

    taillight technology: incandescent lamp vs. light emitting diode (LED)

    Time frame: within one year

  4. Perimetric extent of horizontal meridian

    (Semi-autmated kinetic) perimetry with white vs. red stimuli

    Time frame: within one year

  5. Loss of brightness sensation during anomaloscopic exam

    Loss of brightness sensation during anomaloscopic exam with max. red. stimulus

    Time frame: within one year

07

Study locations

1 site
  • Ulrich SCHIEFER
    Aalen, Deutschland 73430, Germany
08

References and documents

Individual participant data

Plan to share: Undecided — In case of a subsequent study, aiming at assessing the colour sensitivity of single cones, pseudonomized participant data will be shared with the involved researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04060238
Lead sponsor
Aalen University
Collaborators
Karlsruhe Institute of Technology (KIT), Karlsruhe/FRG
Responsible party
Sponsor
First posted
Aug 19, 2019
Start date
Jan 7, 2020
Primary completion
Mar 15, 2020
Completion
Mar 15, 2020
Last update
Mar 31, 2020

Study contacts

Ulrich Schiefer, MD
study chair · Aalen University of Applied Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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