To investigate the extent to which performance measurements in a driving simulator discriminate between glaucoma patients and a control group.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During the test, participants* driving performance (position and speed of the
virtual vehicle, control inputs), will be recorded. High-end eye tracking
(Smart-Eye) will be applied to record head position and rotation, gaze
direction, eyelid opening and pupil size.
Secondary outcome
N.a.
Background summary
Little is known about the relationship between the structural and functional
damage of the nerve fibre layer in glaucoma and vision-related disabilities. In
this study we investigate driving simulation as a means to assess visual
performance. Driving performance will be correlated to structural and
functional clinical parameters.
Study objective
To investigate the extent to which performance measurements in a driving
simulator discriminate between glaucoma patients and a control group.
Study design
This study is an explorative study.
Study burden and risks
Participants of this study do not benefit, study procedures are non-invasive
and take about 30 - 45 minutes. Patients with a history of motion/simulator
sickness will not be included in the study.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
General:
Age >= 18 years and < 85 years.
Informed consent.
Drivers* license and minimally three years of driving experience.
Control group:
Normal visual field (VF) in both eyes (i.e. mean deviation and pattern standard deviation within 95% confidence limits, hemifield test within normal limits, no other VF abnormality).
Glaucoma group:
Glaucoma diagnosis (i.e. if two of the following conditions are met: pattern standard deviation significant at p=0.05, abnormal hemifield test result, cluster of >= 3 points depressed at p=0.05 level or 1 point at p=0.01). VF defects must be reproducible on at least one occasion.
Exclusion criteria
General:
BCVA > 0.3 (LogMAR).
Refractive error ouside -10.0 to +5.0 D range.
Cataract surgery in previous 12 months.
Previous refractive or vitreoretinal surgery.
Evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease.
Previous keratoplastic surgery.
Because driving simulators have been associated with simulator adaptation syndrome (SAS), characterized by autonomic symptoms such as drowsiness, vertigo, or nausea during testing participants with a history of motion/simulator sickness will be excluded from this study.
Control group:
Glaucoma.
IOP >= 22 mm Hg.
Untreated occludable angle with iridolenticular contact or evidence of iridolenticular contact or peripheral anterior synechia.
Presence of disc hemorrhage.
Glaucoma group:
Secondary glaucomas except pigmentary.
Evidence of SAP VF abnormality consistent with other disease.
Design
Recruitment
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 | NL38177.078.11 |