Cataract Clinical Trial
Official 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)
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).
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).
Part 2.2.: Advanced driving simulator test under photopic and under mesopic simulated driving
with and without glare (Würzburg Institute for Traffic Sciences = WIVW) in order to
investigate the influence of glare on the driving behavior
Part 3: Representative driving simulator test (The [altogether fourty] subjects, enrolled in
Part 2, will be enrolled in this part of the study.) Driving simulator test under photopic
and mesopic conditions in oder to investigate glare on representative driving situations.
Driving performance will be evaluated highly-standardized and partially automated on
different parameters of operational and tactical driving behavior (S.A.F.E., Würzburg
Institute for Traffic Sciences = WIVW).
Pass/fail rates are specified as described in the related manuals of the instruments. With
regard to visual acuity measurements and assessment of mesopic contrast vision without/with
glare, results are rated according to DIN 58220 - Part 3/ISO 10938: If less than three out of
five subsequent presentations of an eight-position LANDOLT C (with two oblique and three
horizontal/vertical gap locations in random sequence) are correctly identified, the session
is rated as failed. Overlooking/missing reactions to obstacles (pedestrian [display dummy
with dark clothing]/wild boar at the right roadside) are rated as failed.
For mesopic contrast vision testing, single LANDOLT optotpyes (visual acuity level 0.1 =
2/20) with the contrast levels (1:2, 1:5 and 1:23, respectively, according to AULHORN/HARMS)
are presented via the Optovist Instrument (Vistec, Inc., Manching/Germany) or via the head up
display (HUD) of the simulator vehicle/on road vehicle.
Photopic and mesopic contrast vision tests (without glare) are repeated once in order to
assess the test retest variability of the related test procedure.
1. LANDOLT C chart for presentation of high contrast optotypes according to DIN 58220 -
Part 3/ISO 10938 (Visus GmbH, Stuttgart/Germany)
2. Assessment of low contrast visual acuity using FrACT (Freiburg Visual Acuity Test,
internet version 3.8.1)
3. Assessment of photopic contrast sensitivity, using the MARS Letter Contrast Sensitivity
Test (The Mars Perceptrix Corporation, NY 10514-2523,USA)
4. Assessment of mesopic contrast sensitivity, using the OPTOVIST (VISTEC, Manching/FRG)
5. Judgment of intraocular straylight, using the C-Quant (Straylight meter, OCULUS,
Dutenhofen/FRG)
6. Classification of human crystalline lens opacities, using the BQ 900 slitlamp
(HAAG-STREIT, Köniz/CH), digital photography with dilated pupils, applying the LOCS III
score
7. Densitometry of the crystalline lens, using the Pentacam HR (OCULUS Inc.,
Dutenhofen/FRG)
8. Digital Fundus Photography with dilated pupils (WX3D fundus camera, KOWA Optimed
Deutschland GmbH, Düsseldorf/FRG)
9. Aalen driving simulator: Two high performance VELVET planetarium projectors (Fa. ZEISS,
Jena/FRG), AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display and re-equipped
(BFFT, Gaimersheim/FRG) with externally controllable head up display (HUD) for
presentation of LANDOLT Cs with varying contrast levels, SILAB virtual reality
environment (WIVW, Veitshöchheim/FRG), two mobile glare sources (LED arrays)
10. Aalen on road parcours: AUDI A4 (AUDI Inc., Ingolstadt/FRG) with digital display, with
externally controllable head up display (HUD, VW AG, Wolfsburg/FRG)) for presentation of
LANDOLT Cs with varying contrast levels and equipped with dual brake (VEIGEL GmbH + Co
KG, Künzelsau/FRG)
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