The Impact of Ocular Diseases on Driving: a Prospective Study

Completed

• Conditions: Glaucoma; Macular Degeneration

• Registration Number: NCT02313259
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-08-25
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-10
• Primary Completion: 2015-02-23
• Study Completion: 2015-02-23
• Status Verified: 2015-09
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speed discrimination threshold	Before driving simulation	75% point is taken as a measure of the discrimination threshold.

Secondary Outcome Measures

Name	Time	Method
Driving performance	After speed discrimination task	Probe reaction time task. Speed limits. Respect of traffic safety rules.

Trial Locations

Locations (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec; 🇨🇦 Québec, Quebec, Canada