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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
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
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
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
Trial website
Trial related presentations / publications
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
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

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.