Cataract Clinical Trial
— ContrastValOfficial title:
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)
NCT number | NCT03169855 |
Other study ID # | F-2015-044#A1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2, 2017 |
Est. completion date | December 31, 2018 |
Verified date | January 2019 |
Source | Aalen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 54 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Applied Sciences, Study Course Ophthalmic Optics | Aalen | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Aalen University | DGUV (Deutsche Gesetzliche Unfallversicherung/German Social Accident Insurance Institutions), Steinbeis Transferzentrum AWFE, University of Applied Sciences Aalen, Study Course Mechatronics, University of Applied Sciences Aalen, Study Course Ophthalmic Optics and Optometry, University of Applied Sciences Aalen, Würzburg Institute for Traffic Sciences GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Rank of tested subjects with respect to a vision-related driving ability test | Rank/i.e. sequence of tested subjects with respect to the results of a vision-related driving ability test [see clauses (i) to (iv), Outcome 1] | From date of "first subject in" to date of "last subject out", i.e. over an 18 months period | |
Secondary | Test-retest reliability, expressed as "limits of agreement" (LOA) of a clinical contrast vision test | Test-retest reliability of a clinical photopic/mesopic contrast vision test [see clauses (i) and (ii), Outcome 1] | From date of "first subject in" to date of "last subject out", i.e. over an 18 months period | |
Secondary | Response time (in milliseconds) regarding to the gap recognition of a standardized optotype | Response time regarding gap recognition of a standardized optotype (8 position LANDOLT C) with three contrast levels, presented via the head up display | From date of "first subject in" to date of "last subject out", i.e. over an 18 months period | |
Secondary | Intensity of driving simulator sickness, assessed by a questionnaire | 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 |
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