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Completed

NCT Number: NCT02313259

The Impact of Ocular Diseases on Driving: a Prospective Study

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Glaucoma Ocular Hypertension Retinal Degeneration Retinal Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, G1S 4L8, Canada

About this study

This observational study has two goals:

  • to establish if patients affected by dry AMD have a different speed discriminating threshold using peripheral vision fields than their healthy counterparts.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speed discrimination test

Other

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

Behavioral

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

  1. Speed discrimination threshold

    Time frame: Before driving simulation

    75% point is taken as a measure of the discrimination threshold.

Secondary outcomes

  1. Driving performance

    Time frame: After speed discrimination task

    Probe reaction time task. Speed limits. Respect of traffic safety rules.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 10, 2014
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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