Overview

This trial is active, not recruiting.

Conditions macular degeneration, glaucoma
Treatments speed discrimination test, driving simulation
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Start date February 2012
End date February 2016
Trial size 60 participants
Trial identifier NCT02313259, 2012-1593, DR-002-1370

Summary

The purpose of the study was (1) to determine thresholds for discriminating speed in peripheral fields of patients with dry AMD and (2) to examine the driving skills of licensed drivers with early dry AMD using a driving simulator and to investigate how their healthy counterparts perform on the same driving tasks. We hypothesized that speed discrimination may be better in patients with dry AMD than in healthy control subjects.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
15 patients with early to intermediate AMD (grade 2-8) were enrolled using the Age-Related Eye Disease Study (AREDS) severity scale for AMD.
speed discrimination test
The participant has to stare in the middle of two screens, i.e the reference screen and the test screen. Dots are moving from the center to the edge of the screens at different speeds. The participant is forced to determine if the dots of the test screen are moving faster or slower than the reference screen. The test is designed in Psychtoolbox3. Data analyses performed using MATLAB. Two-alternative forced choice paradigm.
driving simulation
25 km simulated car driving session. The participant is seated in the driver compartment of a real car featuring all the actual components (steering wheel, pedals regulating speed and brakes). He is instructed to respect road regulations as well as safety rules and must perform some driving manoeuvres, such has turning at intersections, stopping when necessary, passing another car, etc. Software Drive 3.0 by Systems Technology Inc., Hawthorne, California, USA. Magnetic head tracker (Flock of Birds, Ascension Technology Corporation, Burlington, Vermont, USA). A fixed-base driving simulator. 2 driving scenarios: a practice (10 minutes) and a main scenario including rural and urban sections (35 minutes).
15 drivers without ocular disease.
speed discrimination test
The participant has to stare in the middle of two screens, i.e the reference screen and the test screen. Dots are moving from the center to the edge of the screens at different speeds. The participant is forced to determine if the dots of the test screen are moving faster or slower than the reference screen. The test is designed in Psychtoolbox3. Data analyses performed using MATLAB. Two-alternative forced choice paradigm.
driving simulation
25 km simulated car driving session. The participant is seated in the driver compartment of a real car featuring all the actual components (steering wheel, pedals regulating speed and brakes). He is instructed to respect road regulations as well as safety rules and must perform some driving manoeuvres, such has turning at intersections, stopping when necessary, passing another car, etc. Software Drive 3.0 by Systems Technology Inc., Hawthorne, California, USA. Magnetic head tracker (Flock of Birds, Ascension Technology Corporation, Burlington, Vermont, USA). A fixed-base driving simulator. 2 driving scenarios: a practice (10 minutes) and a main scenario including rural and urban sections (35 minutes).
15 drivers without ocular disease. Between 18 and 25 years old.
speed discrimination test
The participant has to stare in the middle of two screens, i.e the reference screen and the test screen. Dots are moving from the center to the edge of the screens at different speeds. The participant is forced to determine if the dots of the test screen are moving faster or slower than the reference screen. The test is designed in Psychtoolbox3. Data analyses performed using MATLAB. Two-alternative forced choice paradigm.
driving simulation
25 km simulated car driving session. The participant is seated in the driver compartment of a real car featuring all the actual components (steering wheel, pedals regulating speed and brakes). He is instructed to respect road regulations as well as safety rules and must perform some driving manoeuvres, such has turning at intersections, stopping when necessary, passing another car, etc. Software Drive 3.0 by Systems Technology Inc., Hawthorne, California, USA. Magnetic head tracker (Flock of Birds, Ascension Technology Corporation, Burlington, Vermont, USA). A fixed-base driving simulator. 2 driving scenarios: a practice (10 minutes) and a main scenario including rural and urban sections (35 minutes).
15 patients having a Humphrey visual field mean deviation between -10 and -12 (better eye).
driving simulation
25 km simulated car driving session. The participant is seated in the driver compartment of a real car featuring all the actual components (steering wheel, pedals regulating speed and brakes). He is instructed to respect road regulations as well as safety rules and must perform some driving manoeuvres, such has turning at intersections, stopping when necessary, passing another car, etc. Software Drive 3.0 by Systems Technology Inc., Hawthorne, California, USA. Magnetic head tracker (Flock of Birds, Ascension Technology Corporation, Burlington, Vermont, USA). A fixed-base driving simulator. 2 driving scenarios: a practice (10 minutes) and a main scenario including rural and urban sections (35 minutes).

Primary Outcomes

Measure
Speed discrimination threshold
time frame: Before driving simulation

Secondary Outcomes

Measure
Driving performance
time frame: After speed discrimination task

Eligibility Criteria

Male or female participants from 18 years up to 95 years old.

Inclusion Criteria: - Best-corrected visual acuity (BCVA) had to be at least 20/50 (6/15). - Binocular visual field (VF) should not be less than 120° along the horizontal meridian and 20° above and below the same meridian. - Valid driving license - Diagnosis of bilateral dry AMD (AMD group) or open-angle glaucoma (glaucoma group) Exclusion Criteria: - Diplopia - Cognitive impairment - Other ocular diseases

Additional Information

Official title The Impact of Ocular Diseases on Driving: a Prospective Study
Principal investigator Gilles Lalonde, MD
Description This observational study has two goals: 1. to establish if patients affected by dry AMD have a different speed discriminating threshold using peripheral vision fields than their healthy counterparts. 2. to determine if the driving skills of AMD and glaucoma patients differ from healthy controls. Two tasks will be used: 1) A speed discrimination test. (Glaucoma patient are not asked to perform this task as it assesses the peripheral visual fields, which is affected by the disease.) 2) A driving simulation session. Participant will undergo both tests on the same day, no later than a month after the initial recruitement visit. For both diseases, patients will be compared to healthy controls matched for age and gender, but also to a younger control group. The latter group was added in order to take into account the normal aging impact on driving skills (visual and cognitive). Our hypothesis is that AMD patient will show a better speed discriminating threshold than matched control and maybe better or equal to the younger control groups. We also hypothesize that driving skills involving peripheric speed awareness, such as passing another car, will be enhanced in the AMD group when compared to glaucoma patients and age-matched control group.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.