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Completed

NCT Number: NCT04060238

Effect of Protanopia on the Brightness Perception of Brake Lights

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Ulrich SCHIEFER

Aalen, Deutschland, 73430, Germany

About this study

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:

  • At which contrast threshold (relative brightness) does a proband with protanopia recognize a brake light compared to a normal person?
  • 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?
  • 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Anomaloscope (colour vision test)

Diagnostic 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")

Primary outcomes

  1. Contrast sensitivity (I)

    Time frame: within one year

    Contrast sensitivity between taillight and brake light under two luminance conditions

Secondary outcomes

  1. Reaction time

    Time frame: within one year

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

  2. Contrast sensitivity (II)

    Time frame: within one year

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

  3. Reaction time (II)

    Time frame: within one year

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

  4. Perimetric extent of horizontal meridian

    Time frame: within one year

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

  5. Loss of brightness sensation during anomaloscopic exam

    Time frame: within one year

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

Sponsors and collaborators

Lead sponsor

Aalen University

Other

Collaborators

  • Karlsruhe Institute of Technology

Registry information

Official study title

Investigation of the Effect of Protanopia ("Red Blindness") on the Brightness Perception of Brake Lights and Their Effect on Reaction Time

Acronym: ProLight

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2019
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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