NCT03169855: ContrastVal

Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability

Completed Last updated 10 January 2019

What this trial tests

trial testing Slit lamp (LOCS III Score) in Cataract in 54 participants. Completed in 31 December 2018.

Timeline

2 May 2017

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	Aalen University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	54
Start date	2 May 2017
Primary completion	31 December 2018
Estimated completion	31 December 2018
Sites	1 location across Germany

Drugs / interventions tested

• Slit lamp (LOCS III Score)

Conditions studied

• Cataract — all drugs for Cataract →
• Traffic Accident — all drugs for Traffic Accident →
• Vision Disorders — all drugs for Vision Disorders →
• Driving Impaired — all drugs for Driving Impaired →

Sponsor

Aalen University

Who can join

18 and older, any sex, with Cataract or Traffic Accident. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A) The main purposes of this study are (i) to develop a related virtual reality (VR) environment in order to judge the nighttime driving ability under mesopic and under glare conditions (ophthalmologically healthy subjects and patients with incipient to intermediate cataract, i.e. opacities of the human lens, will participate in this study), (ii) to validate the above-mentioned VR environment with respect to a related on-road driving scenario under mesopic and glare conditions, (iii) to validate clinical photopic and mesopic contrast vision tests and glare tests with respect to the prediction of nighttime driving ability, (iv) to assess the test retest reliability of clinical photopic and mesopic contrast vision tests

B) Background:

An intact mesopic vision and a glare sensitivity within a normal range are essential pre-requisites for safe driving at nighttime (DOG \& BVA, 2011). Anderson \& Holiday (1995) have shown that (simulated) opacities of the refractive media (with only minor effects on daytime visual acuity) induce a pronounced impairment of contrast sensitivity under nighttime conditions. Especially under glare conditions by the headlights of traffic on the opposite lane or by stationary street illumination, an impairment of the mesopic vision may cause traffic hazards. The prevalence of impairments of the central visual acuity, the mesopic vision and the glare sensitivity is significantly higher for subjects being involved in nighttime traffic accidents (Lachenmayr, 1998). Furthermore, these impairments occur more frequently in aged drivers and are, among others, related to an increase of age-related media opacities (Aulhorn \& Harms, 1970, Babizhayev, 2003). Due to the demographic change, the relevance of nighttime driving ability is increasing in the next years since more and more aged employees will participate at the motorized traffic at night.

The German Fahrerlaubnisverordnung (FEV i.e. driving license regulation) specifies pass/fail criteria with regard to mesopic vision and glare sensitivity. The luminance level during nighttime driving is usually between 0.01 and 1 cd/m\^2, and therefore can be attributed to the level of mesopic vision. However, over the last years, the attempt was made to introduce photopic contrast sensitivity test to diagnose nighttime driving ability (i.e. testing of contrast vision under daytime conditions without time consuming adaptation procedures). Current research aims at investigating the relationship between contrast tests under various luminance conditions (Wilhelm et al, 2013). It is questionable, whether photopic tests are at all reliable predictors with regard to nighttime driving (Gramberg-Danielsen et al., 1984, Hertenstein et al., Graefe´s Archive of Ophthalmology, 2016).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contrast Sensitivity and Night Driving in Older People: Quantifying the Relationship Between Visual Acuity, Contrast Sensitivity, and Hazard Detection Distance in a Night-Time Driving Simulator.
   Jones PR, Ungewiss J, Eichinger P, Wörner M, et al · · 2022 · cited 12× · PMID 35966995 · DOI 10.3389/fnhum.2022.914459
2. Does intraocular straylight predict night driving visual performance? Correlations between straylight levels and contrast sensitivity, halo size, and hazard recognition distance with and without glare.
   Ungewiss J, Schiefer U, Eichinger P, Wörner M, et al · · 2022 · cited 7× · PMID 36177386 · DOI 10.3389/fnhum.2022.910620