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CompletedNCT04060238

Effect of Protanopia on the Brightness Perception of Brake Lights

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

Status
Completed
Phase
Study type
Observational
Enrollment
16 (actual)
Sponsor
Aalen University · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers

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

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.

Conditions

Interventions

TypeNameDescription
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")

Timeline

Start date
2020-01-07
Primary completion
2020-03-15
Completion
2020-03-15
First posted
2019-08-19
Last updated
2020-03-31

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04060238. Inclusion in this directory is not an endorsement.