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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

glare sensitivity

impairments of visual functions

Condition category

Condition code

Eye

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]

Not applicable

Comparator / control treatment

no treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

glare sensitivity measured with a straylight meter

Timepoint [1]

immediately after observation

Primary outcome [2]

visual acuity measured with ETDRS charts

Timepoint [2]

immediately after observation

Primary outcome [3]

visual field measured with computer perimetry

Timepoint [3]

immediately after observation

Secondary outcome [1]

cataract as measured with LOCS III

Timepoint [1]

immediately after observation

Secondary outcome [2]

eye pressure as assessed by Goldmann applanation tonometry

Timepoint [2]

immediately after observation

Secondary outcome [3]

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]

immediately after observation

Secondary outcome [4]

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]

immediately after observation

Secondary outcome [5]

eye diseases as assessed by slitlamp examination, Goldmann tonometry and computer perimetry

Timepoint [5]

immediately after observation

Secondary outcome [6]

vision related quality of life as measured by the NEI-VFQ25 questionaire

Timepoint [6]

immediately after observation

Secondary outcome [7]

contrast sensitivity as assessed by Pelli-Robson charts

Timepoint [7]

immediately after observation

Eligibility

Key inclusion criteria

active car driver

Minimum age

20 Years

Maximum age

No limit

Sex

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

1/09/2003

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

2422

Accrual to date

Final

Recruitment outside Australia

Country [1]

Austria

State/province [1]

Country [2]

Germany

State/province [2]

Country [3]

Belgium

State/province [3]

Country [4]

Netherlands

State/province [4]

Country [5]

Spain

State/province [5]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

European Commission

Address [1]

European Commission
SDME 2/2
B-1049 Brussels
Belgium

Country [1]

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]

Charities/Societies/Foundations

Name [1]

Ernst Fuchs Foundation

Address [1]

Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg
Austria

Country [1]

Austria

Other collaborator category [1]

University

Name [1]

Paracelsus Medical University Salzburg

Address [1]

Department of Ophthalmology
St. Johanns-Spital
Muellner Hauptstrasse 48
5020 Salzburg

Country [1]

Austria

Other collaborator category [2]

University

Name [2]

Netherlands Ophthalmic Research Institute

Address [2]

Meibergdreef 47
1105 BA Amsterdam

Country [2]

Netherlands

Other collaborator category [3]

University

Name [3]

Vrije Universiteit Medical Center

Address [3]

Department of Ophthalmology
Dr L.J. van Rijn
PO Box 7057
NL-1007 MB Amsterdam

Country [3]

Netherlands

Other collaborator category [4]

University

Name [4]

Centro de Oftalmologia Barraquer

Address [4]

Catedra de Recerca en Oftalmologia J. Barraquer
Dr. R.I. Barraquer and Dr. R. Michael
Muntaner, 314
E-08021 Barcelona

Country [4]

Spain

Other collaborator category [5]

University

Name [5]

University of Tuebingen

Address [5]

Universitaets-Augenklinik
Prof. Dr. H. Wilhelm
Schleichstrasse 12-16
D-72076 Tuebingen

Country [5]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Christian Nischler

Address

Paracelsus Medical University Salzburg
Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg

Country

Austria

Phone

+43-662-4482-57289

Fax

+43-662-4482-3703

c.nischler@salk.at

Contact person for scientific queries

Name

Dr. Christian Nischler

Address

Paracelsus Medical University Salzburg
Department of Ophthalmology
Muellner Hauptstrasse 48
5020 Salzburg

Country

Austria

Phone

+43-662-4482-57289

Fax

+43-662-4482-3703

c.nischler@salk.at

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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