To examine the OcuDrive test package in glaucoma patients and healthy controls in relation to fitness to drive. The main objective is to find the tests from the package that discriminate best between fit and unfit drivers.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Driving simulator performance, quantified by the occurrence of crashes as pass
or fail.
Secondary outcome
Secondary study parameters/endpoints
Other secondary study parameters are the data gathered with the OcuDrive test
package. These variables will be included in the discriminant analysis but will
also be compared between fit and unfit group, as determined by driving
simulator performance. Lastly, the data from the questionnaires will be
analysed to evaluate the differences between those groups.
Other study parameters
Other study parameters include personal data such as age, education and sex.
These data will be compared for both groups (glaucoma and healthy controls) to
ensure that both groups have similar demographics.
Background summary
The effects of glaucoma are usually measured with visual field tests. When the
visual field defects are mild to moderate driving is still allowed and many
glaucoma patients do continue to drive. However, assessing the visual system
might be hard to do reliably in older people and it might not be sufficient for
selecting unfit drivers. Therefore, the OcuDrive test package has been
composed. The OcuDrive test package assesses the entire neurovisual system,
including measures of executive function, processing speed, and attention.
Study objective
To examine the OcuDrive test package in glaucoma patients and healthy controls
in relation to fitness to drive. The main objective is to find the tests from
the package that discriminate best between fit and unfit drivers.
Study design
A cross-sectional observational study.
Study burden and risks
In this study the participants will receive a small financial compensation of
20 euro*s in the form of a gift certificate for their time and a free test of
their visual acuity. The risks of participating are minimal, and the burden of
participation is small, since all tests will be done on paper, the computer or
the Ocusweep device. The only risk is simulator sickness from driving in the
driving simulator. Extra attention will be paid to participants when they are
in the driving simulator and after each ride they will be asked how they feel
and if they are ready to continue with the next ride. When simulator sickness
occurs, and the participants wants to stop, the simulator will be stopped
immediately. The total time for a complete assessment will be 3.5 hours,
including several breaks. Participants will also fill in a short questionnaire
at home before coming to the test location, which will take about 15 minutes.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Age over 65 years old
Have a valid driver*s licence or held one until recently (up to six months before the test day)
Visual acuity better than 0.5
Speaks the Dutch language
Exclusion criteria
Motor disorders
Medication use that prohibits driving (IDCATS III)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67866.042.18 |
| Other | UMCG Research Database: 201800808 & NTR 7576 |