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Trial registered on ANZCTR


Registration number
ACTRN12612000195853
Ethics application status
Approved
Date submitted
14/02/2012
Date registered
15/02/2012
Date last updated
15/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relevance of glare sensitivity and impairment of visual function among European drivers
Scientific title
Relevance of glare sensitivity and impairment of visual function among European drivers
Secondary ID [1] 279937 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glare sensitivity 285846 0
impairments of visual functions 285847 0
Condition category
Condition code
Eye 286026 286026 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of glare sensitivity and impairments of visual functions. The subjects undergo a complete ophthalmological examination including slitlamp examination and Goldmann tonometry as well as a battery of visual function tests, including tests for visual acuity with ETDRS charts, visual field as assessed with computer perimetry, contrast sensitivity as assessed by Pelli-Robson charts, straylight (glare sensitivity) as assessed by a straylight meter and useful field of view as assessed by the UFOV test.
We will include subjects of the following age group categories: 45-54 years, 55-64 years, 65-74 years and 75 years of age and older, as well as a 20 to 30 years of age reference group.
Cross sectional study. Only one observation.
Intervention code [1] 284258 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286516 0
glare sensitivity measured with a straylight meter
Timepoint [1] 286516 0
immediately after observation
Primary outcome [2] 286517 0
visual acuity measured with ETDRS charts
Timepoint [2] 286517 0
immediately after observation
Primary outcome [3] 286518 0
visual field measured with computer perimetry
Timepoint [3] 286518 0
immediately after observation
Secondary outcome [1] 296059 0
cataract as measured with LOCS III
Timepoint [1] 296059 0
immediately after observation
Secondary outcome [2] 296060 0
eye pressure as assessed by Goldmann applanation tonometry
Timepoint [2] 296060 0
immediately after observation
Secondary outcome [3] 296061 0
self reported driving difficulties as assessed by a questionaire, which was developed only for this study. It includes questions about difficulties during night, bad weather, parking, rushhour, highway, accidents and injuries.
Timepoint [3] 296061 0
immediately after observation
Secondary outcome [4] 296062 0
driving habits as assessed by questionaire, which was developed only for this study. It includes questions about driven kilometers per year, purpose of driving, region of driving and estimated speed relative to other traffic.
Timepoint [4] 296062 0
immediately after observation
Secondary outcome [5] 296063 0
eye diseases as assessed by slitlamp examination, Goldmann tonometry and computer perimetry
Timepoint [5] 296063 0
immediately after observation
Secondary outcome [6] 296064 0
vision related quality of life as measured by the NEI-VFQ25 questionaire
Timepoint [6] 296064 0
immediately after observation
Secondary outcome [7] 296085 0
contrast sensitivity as assessed by Pelli-Robson charts
Timepoint [7] 296085 0
immediately after observation

Eligibility
Key inclusion criteria
active car driver
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
non-active car driver

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4128 0
Austria
State/province [1] 4128 0
Country [2] 4129 0
Germany
State/province [2] 4129 0
Country [3] 4130 0
Belgium
State/province [3] 4130 0
Country [4] 4131 0
Netherlands
State/province [4] 4131 0
Country [5] 4132 0
Spain
State/province [5] 4132 0

Funding & Sponsors
Funding source category [1] 284706 0
Government body
Name [1] 284706 0
European Commission
Address [1] 284706 0
European Commission
SDME 2/2
B-1049 Brussels
Belgium
Country [1] 284706 0
Belgium
Primary sponsor type
Government body
Name
European Commission
Address
European Commission
SDME 2/2
B-1049 Brussels
Belgium
Country
Belgium
Secondary sponsor category [1] 283606 0
Charities/Societies/Foundations
Name [1] 283606 0
Ernst Fuchs Foundation
Address [1] 283606 0
Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg
Austria
Country [1] 283606 0
Austria
Other collaborator category [1] 260542 0
University
Name [1] 260542 0
Paracelsus Medical University Salzburg
Address [1] 260542 0
Department of Ophthalmology
St. Johanns-Spital
Muellner Hauptstrasse 48
5020 Salzburg
Country [1] 260542 0
Austria
Other collaborator category [2] 260543 0
University
Name [2] 260543 0
Netherlands Ophthalmic Research Institute
Address [2] 260543 0
Meibergdreef 47
1105 BA Amsterdam
Country [2] 260543 0
Netherlands
Other collaborator category [3] 260544 0
University
Name [3] 260544 0
Vrije Universiteit Medical Center
Address [3] 260544 0
Department of Ophthalmology
Dr L.J. van Rijn
PO Box 7057
NL-1007 MB Amsterdam
Country [3] 260544 0
Netherlands
Other collaborator category [4] 260545 0
University
Name [4] 260545 0
Centro de Oftalmologia Barraquer
Address [4] 260545 0
Catedra de Recerca en Oftalmologia J. Barraquer
Dr. R.I. Barraquer and Dr. R. Michael
Muntaner, 314
E-08021 Barcelona
Country [4] 260545 0
Spain
Other collaborator category [5] 260546 0
University
Name [5] 260546 0
University of Tuebingen
Address [5] 260546 0
Universitaets-Augenklinik
Prof. Dr. H. Wilhelm
Schleichstrasse 12-16
D-72076 Tuebingen
Country [5] 260546 0
Germany

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Insight in the prevalence of vision impairments in the driving population is important, both for evaluating the effectiveness of the current regulations on visual functions of drivers and for estimating the impact of possible new regulations. In past research, attention has been focussed on demonstrating the direct relation between impairments of visual function and driving (in)capacity. The prevalence of
impairments has been infrequently addressed. Large studies on this issue date from several years back and were not performed in Europe. In the present research, we
aimed at investigating the prevalence of impairments of a number of visual functions in a variety of European countries.
Methods: We investigated 2422 drivers in 5 participating clinics: the Vrije Universiteit medical centre in Amsterdam; the Landesklinik fuer Augenheilkunde und Optometrie in Salzburg; the Universitaets-Augenklinik in Tuebingen; the Centro de Oftalmologia Barraquer in Barcelona and the Universitair Ziekenhuis Antwerpen. Participants belonged to either one of the following age categories: 45-54 years, 55-
64 years, 65-74 years and 75- years of age and older. In addition, we recruited a smaller group with ages between 20 and 30 years, to serve as a reference group.
Subjects participated in the measurement of a large number of visual functions: visual acuity, both with driving correction and with best correction, visual field, contrast sensitivity, straylight and Useful Field of View. In addition, subjects were asked to fill in two questionnaires. One questionnaire was about driving habits, driving difficulties and self reported accidents. The other questionnaire was the NEIVFQ25 into vision related quality of life. All subjects underwent an ophthalmological examination, comprising the evaluation of current and past ocular diseases and abnormalities.
Results: We found that the prevalence of impairments of visual functions is low in the younger age groups, and raises to relevant percentages in the higher age
groups. This counts for all modalities of visual function, but especially for those functions that are not included in the current regulations, such as straylight and Useful Field of View. The percentage of subjects with inadequate correction of their refractive error is rather high and about equal in all age groups. This inadequate correction results in a lower than optimal visual acuity.
Conclusions: The present study is the largest study into the prevalence of visual impairments that has been performed in Europe so far. The results demonstrate that there are quite a number of subjects that do not meet the current European standards on visual acuity and visual field, particularly in the highest age groups. The requirements on visual acuity could be met in the majority of cases if refractive errors were adequately corrected. In all age groups, acuity can be improved in a significant number of subjects by optimization of correction of refractive errors, although in the younger groups, the majority of subjects, even with their (sub-optimal) habitual driving correction, still meet the current standards. Our findings regarding the higher prevalence of impairments of contrast
sensitivity and straylight in the elderly groups are in concordance with the larger number of eye diseases and abnormalities that are found in these age groups. Past
research has demonstrated the importance of adequate contrast sensitivity for driving safety. This suggests, in combination with our results, that contrast sensitivity could
have a more important role in the assessment of drivers than in the current regulations. For such role, a better establishment of cut-off values would be necessary. Past research into the role of straylight in traffic safety has been hampered by the lack of an adequate measurement method. Our results demonstrate that straylight sensitivity can be adequately measured in the majority of subjects in a
population study, facilitating future research into its relevance.
Trial website
Trial related presentations / publications
Van Rijn LJ, Nischler C, Michael R, Heine C, Coeckelbergh T, Wilhelm H, Grabner G, Barraquer RI, van den Berg TJTP. Prevalence of impairment of visual function in European drivers. Acta Ophthalmol 2011 Mar; 89(2):124-31. doi: 10.1111/j.1755-3768.2009.01640.x.

Nischler C, Michael R, Wintersteller C, Marvan P, Emesz M, van Rijn LJ, van den Berg TJTP, Wilhelm H, Coeckelbergh T, Barraquer RI, Grabner G, Hitzl W. Cataract and pseudophakia in elderly European drivers. Eur J Ophthalmol 2010; 20:892-901.

Van den Berg TJTP, van Rijn LJ, Kaper-Bongers R, Vonhoff DJ, Voelker-Dieben HJ, Grabner G, Nischler C, Emesz M, Wilhelm H, Gamer D, Schuster A, Franssen L, de Wit GC, Coppens JE. Disability glare in the aging eye. Assessment and impact on driving. J Optom 2009; 2:112-118.

Michael R, van Rijn LJ, van den Berg TJ, Barraquer RI, Grabner G, Wilhelm H, Coeckelbergh T, Emesz M, Marvan P, Nischler C. Association of lens opacities, intraocular straylight, contrast sensitivity and visual acuity in European drivers. Acta Ophthalmol 2009; 87(6):666-671.
Public notes

Contacts
Principal investigator
Name 33772 0
Address 33772 0
Country 33772 0
Phone 33772 0
Fax 33772 0
Email 33772 0
Contact person for public queries
Name 17019 0
Dr. Christian Nischler
Address 17019 0
Paracelsus Medical University Salzburg
Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg
Country 17019 0
Austria
Phone 17019 0
+43-662-4482-57289
Fax 17019 0
+43-662-4482-3703
Email 17019 0
c.nischler@salk.at
Contact person for scientific queries
Name 7947 0
Dr. Christian Nischler
Address 7947 0
Paracelsus Medical University Salzburg
Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg
Country 7947 0
Austria
Phone 7947 0
+43-662-4482-57289
Fax 7947 0
+43-662-4482-3703
Email 7947 0
c.nischler@salk.at

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary