Macular DegenerationNCT02313259
The Impact of Ocular Diseases on Driving: a Prospective Study
An observational study of Macular Degeneration and Glaucoma, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Glaucoma
- What is being tested?
- Speed discrimination test and Driving simulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to 23 Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Diplopia
- Cognitive impairment
- Other ocular diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8
About this 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.
Read the detailed description
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.
- Conditions
- Macular Degeneration, Glaucoma
- Being tested
- Speed discrimination test, Driving simulation
- Medical subject headings
- Macular Degeneration, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed discrimination testOther
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 simulationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| AMD controls | 15 patients with early to intermediate AMD (grade 2-8) were enrolled using the Age-Related Eye Disease Study (AREDS) severity scale for AMD. Receives: Other: Speed discrimination test; Behavioral: Driving simulation | |
| Age-matched controls | 15 drivers without ocular disease. Receives: Other: Speed discrimination test; Behavioral: Driving simulation | |
| Young controls | 15 drivers without ocular disease. Between 18 and 25 years old. Receives: Other: Speed discrimination test; Behavioral: Driving simulation | |
| Glaucoma patients | 15 patients having a Humphrey visual field mean deviation between -10 and -12 (better eye). Receives: Behavioral: Driving simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed discrimination threshold
75% point is taken as a measure of the discrimination threshold.
Measured: Before driving simulation
Secondary outcomes (1)
Driving performance
Probe reaction time task. Speed limits. Respect of traffic safety rules.
Measured: After speed discrimination task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startFeb 2012
- Primary completion23 Feb 2015
- Study completion23 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Lalonde, MD, Principal investigator, Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City.Marc Hébert, PhD, Study director, Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313259
- Sponsor's protocol ID
- 2012-1593, DR-002-1370
- Status last verified
- Sep 2015
- First submitted
- 25 Aug 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ocular Diseases on Driving: a Prospective Study
- ClinicalTrials.gov ID
- NCT02313259
- Acronym / sponsor ID
- 2012-1593, DR-002-1370
- Conditions
- Macular Degeneration, Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 23 Feb 2015 (actual)
- Study completion
- 23 Feb 2015 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMD controls | – | Other: Speed discrimination test, Behavioral: Driving simulation15 patients with early to intermediate AMD (grade 2-8) were enrolled using the Age-Related Eye Disease Study (AREDS) severity scale for AMD. |
| Age-matched controls | – | Other: Speed discrimination test, Behavioral: Driving simulation15 drivers without ocular disease. |
| Young controls | – | Other: Speed discrimination test, Behavioral: Driving simulation15 drivers without ocular disease. Between 18 and 25 years old. |
| Glaucoma patients | – | Behavioral: Driving simulation15 patients having a Humphrey visual field mean deviation between -10 and -12 (better eye). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- Diplopia
- Cognitive impairment
- Other ocular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speed discrimination testThe 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. | Other | AMD controls, Age-matched controls, Young controls |
| Driving simulation25 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). | Behavioural | AMD controls, Age-matched controls, Glaucoma patients, Young controls |
Primary outcome
Speed discrimination threshold
Time frame: Before driving simulation
75% point is taken as a measure of the discrimination threshold.
1 secondary outcome
Driving performance
Time frame: After speed discrimination task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Lalonde, MD principal investigator
Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City.
Marc Hébert, PhD study director
Centre Universitaire d'Ophtalmologie (CUO), Saint-Sacrement Hospital, Quebec City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration and Glaucoma, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed discrimination threshold (time frame: Before driving simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.