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

NCT03169855 | Completed DMC

• 1 other identifier: F-2015-044#A1
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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).

Conditions

Cataract; Traffic Accident; Vision Disorders; Driving Impaired

Keywords

Traffic Ophthalmology; Glare; Cataract; Nighttime driving; contrast sensitivity; mesopic vision

Outcome Measures

Primary Outcomes (1)

• 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

  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

  From date of "first subject in" to date of "last subject out", i.e. over an 18 months period

Secondary Outcomes (4)

• 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

• 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

• 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

Study Arms (2)

Refractive media opacities: present

Refractive media opacities: present

Refractive media opacities: absent

Refractive media opacities: absent

Diagnostic Test: Slit lamp (LOCS III Score)

Interventions

Slit lamp (LOCS III Score) DIAGNOSTIC_TEST

Diagnostic procedure only

Also known as: Oculus Pentacam (Scheimpflug procedure, densitometry)

Refractive media opacities: absent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ophthalmologically healthy subjects and patients with incipient to intermediate cataract.

You may qualify if:

• 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

You may not qualify if:

• 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)
• amblyopia
• strabismus
• ocular motility disorders
• nystagmus
• double vision
• albinism
• 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

Sponsors & Collaborators

• Aalen University: lead
• DGUV (Deutsche Gesetzliche Unfallversicherung/German Social Accident Insurance Institutions): collaborator
• Study Course Ophthalmic Optics and Optometry, University of Applied Sciences Aalen: collaborator
• Study Course Mechatronics, University of Applied Sciences Aalen: collaborator
• Steinbeis Transferzentrum AWFE, University of Applied Sciences Aalen: collaborator
• Würzburg Institute for Traffic Sciences GmbH: collaborator

Study Sites (1)

University of Applied Sciences, Study Course Ophthalmic Optics

Aalen, Baden-Wurttemberg, 73430, Germany

Location

MeSH Terms

Conditions

Cataract; Vision Disorders

Interventions

Slit Lamp Microscopy

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ulrich Schiefer, Prof. Dr.

  Aalen University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 30, 2017
• Study Start: May 2, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)