Clinical trial NCT02313259: The Impact of Ocular Diseases on Driving: a Prospective Study
Official title: The Impact of Ocular Diseases on Driving: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Glaucoma
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients (with glaucoma or AMD) were recruited from the Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital in Quebec City.

Participants in control groups are residents of Quebec City.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speed discrimination threshold
timeFrame: Before driving simulation
Secondary outcomes:
measure: Driving performance
timeFrame: After speed discrimination task
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
state: Quebec
Study officials:
affiliation: Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City.
name: Gilles Lalonde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City
name: Marc Hébert, PhD
role: STUDY_DIRECTOR
References: