Validation of Mesopic and Photopic Contrast Vision Tests With Respect to Nighttime Driving Ability (ContrastVal) - Influence of Dynamic Glare on (Aged) Motorist (With/Without Media Opacities)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Pass/fail rate (i.e. ratio of "no. of subjects passed" by "total no. of participants") with respect to a vision-related driving ability test
Study Overview
Brief Summary
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).
Detailed Description
Subjects and Methods Adult patients with a distant binocular visual acuity of ≥ 0.8 (≥ 16/20; habitual correction) and healthy control subjects will be included in this explorative study after informed consent.
The study will be subdivided in the following (three) parts:
Part 1: Validation of the Aalen driving simulator set-up (ten patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and ten age- and gender-correlated ophthalmologically healthy control subjects will be enrolled) Part 1.1.: Comprehensive ophthalmological/optical examination (Aalen University of Applied Sciences) including a detailed ophthalmological and medical history.
Part 1.2.: Baseline driving simulator test under mesopic conditions with/without glare under simulated static/simulated driving conditions (Aalen University of Applied Sciences) Part 1.3.: Baseline on road test under mesopic conditions with/without glare, under on road static/on road driving conditions (Aalen University of Applied Sciences) (If possible, the sequence of Part 1.2. and Part 1.3. will be randomly assigned.)
Part 2: Advanced driving simulator test (twenty patients with incipient to moderate cataract, i.e. opacities of the human lens of varying localization and of various degree of expression in at least one eye and twenty age- and gender-correlated ophthalmologically healthy control subjects will be enrolled. Subjects being enrolled in Part 1, will be asked to participate also at Part 2 and Part 3.) Part 2.1.: Comprehensive ophthalmological/optical examination of all (newly) enrolled patients and subjects who have not already been examined in Part. 1.1. (Aalen University of Applied Sciences).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age ≥ 18 years (preferred: age, exceeding 50 yrs.)
- •Minimum distant visual acuity (with habitual correction) 0.8 (16/20, single optotypes, LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 - Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
- •ametropia maximum spherical ametropia sph ±8.00 dpt maximum maximum astigmatism cyl 2.00 dpt
- •normal (age-corrected) visual field
- •clear refractive media OR incipient to intermediate cataract
- •informed consent
Exclusion Criteria
- •epilepsy / psychiatric disorders
- •drugs, interfering with reaction time and/or with visual acuity or with refractive status of the eye
- •deficient driving license
- •yearly mileage less than 3000 km/y (less than 1.864 miles/y)
- •ophthalmological exclusion criteria: all ophthalmological diseases or abnormalities, with the exception of those, listed in the above-mentioned inclusion criteria
- •amblyopia
- •strabismus
- •ocular motility disorders
- •nystagmus
- •double vision
- •glaucoma / IOP exceeding 22 mmHg
- •shallow anterior chamber/risk of angle closure glaucoma (van HERICK grade less than 2)
- •macular diseases / maculopathy
- •diabetic retinopathy (blood sugar-related retinal disease)
- •status post severe eye injuries
- •eye surgery within the last three months (, related to the time point of recruitment)
- •Infectious diseases (conjunctivitis, corneal inflammation, uveitis)
- •very dry eyes (sicca symptoms)
- •drugs inducing miosis
- •any other eye disorders that affect the image quality
Outcomes
Primary Outcomes
Pass/fail rate (i.e. ratio of "no. of subjects passed" by "total no. of participants") with respect to a vision-related driving ability test
Time Frame: From date of "first subject in" to date of "last subject out", i.e. over an 18 months period
Pass/fail rates will be assessed for vision related driving ability tests: (i) clinical photopic/mesopic contrast vision tests, (ii) glare tests, (iii) of driving simulator tests under mesopic conditions with and without glare, and (iv) on-road tests under mesopic conditions with and without glare
Secondary Outcomes
- Test-retest reliability, expressed as "limits of agreement" (LOA) of a clinical contrast vision test(From date of "first subject in" to date of "last subject out", i.e. over an 18 months period)
- Response time (in milliseconds) regarding to the gap recognition of a standardized optotype(From date of "first subject in" to date of "last subject out", i.e. over an 18 months period)
- Rank of tested subjects with respect to a vision-related driving ability test(From date of "first subject in" to date of "last subject out", i.e. over an 18 months period)
- Intensity of driving simulator sickness, assessed by a questionnaire(From date of "first subject in" to date of "last subject out", i.e. over an 18 months period)