GlaucomaNCT03333096
Assessing Neurovisual Function in Patients With Cognitive Impairment
A study testing Ocusweep test battery and Neuropsychological test battery in people with Glaucoma and Mild Cognitive Impairment, run by Turku University Hospital at 1 site in Finland.
Trial summary
The aim of this study is to measure fitness to drive in patients with a visual and a cognitive impairment. To do so, Ocusweep is used in patients with glaucoma and Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Mild Cognitive Impairment, Glaucoma and Mild Cognitive Impairment
- What is being tested?
- Ocusweep test battery and Neuropsychological test battery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- 1 Dec 2017to 1 Jan 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Be at least 65 years old
- Fit into one of the four groups of participants
- No other eye diseases than glaucoma
- Still be able to and allowed to drive a car
- Be able to visit the Turku Driver's Clinic for testing
Who cannot join
- A history of neurological disorders, depression or anxiety
- Motor problems
- Visual acuity less than 0.5
- Score over 6 in Geriatric Depression Scale questionnaire (GDS 15)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to measure fitness to drive in patients with a visual and a cognitive impairment. To do so, Ocusweep is used in patients with glaucoma and Mild Cognitive Impairment. The participants will be divided over four groups; patients with glaucoma, patients with cognitive impairment, patients with both and a healthy control group. Differences in performance on Ocusweep in the four different groups of participants are expected. These effects may be related to fitness to drive, which is why those results will be compared to traditional neuropsychological measures of fitness to drive. the hypothesis of the current study is that the Ocusweep performance is related to performance on other measures of fitness to drive.
- Being tested
- Ocusweep test battery, Neuropsychological test battery
- Keywords
- Glaucoma, Mild Cognitive Impairment, Ocusweep, Reaction Time, Neuropsychology, Dementia, Alzheimer's Disease, Brain Diseases
- Medical subject headings
- Glaucoma, Cognitive Dysfunction, Dementia, Alzheimer Disease, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocusweep test batteryDevice
Ocusweep test battery to measure vision, visual system and cognitive performance including attention
(Comparison of Ocusweep system to conventional neuropsychological test methods)
(With the help of Ocusweep tests, information is obtained about the functioning of the whole visual system - from the ability of the eye to see to the efficiency of the brain to process visual information and the accuracy of eye movements)
Neuropsychological test batteryDiagnostic test
Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma and mild cognitive impairment | Other | Device: Ocusweep test battery Neuropsychological test battery
Ocusweep system compared to neuropsychological testing Receives: Device: Ocusweep test battery; Diagnostic Test: Neuropsychological test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception speed
Measured by Ocusweep RTP-test
Measured: 2 years
Evidence of cognitive impairment measured by MoCA-test
Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Measured: 2 years
Evidence of impaired attentional ability - Cognitive profile
Measured by performing mazes. Unit of measure is seconds it takes to perform and number of errors.
Measured: 2 years
Evidence of impaired Executive Functioning - Cognitive profile 1/2
Measured by the Trail Making Test. Unit of measure is seconds to perform the test, which will be converted in a percentile score.
Measured: 2 years
Evidence of impaired Executive Functioning - Cognitive profile 2/2
Measured by the Trail Making Test. Unit of measure is errors made during the test.
Measured: 2 years
Evidence of impaired Visuoconstructive abilities - Cognitive profile
Measured by the Benton Visual Retention Test. Unit of measure is number of correctly drawn designs (0-10)
Measured: 2 years
Evidence of slow reaction time - Cognitive profile
Measured with Vienna Test System. Unit of measure is reaction time in ms. Results will be converted into percentile scores.
Measured: 2 years
Evidence of impaired visual attention measured by UFOV-test - Cognitive Profile
Vision and visual attention measured with Useful Field of View. Unit of measure is milliseconds which is converted in group scores provided by UFOV.
Measured: 2 years
Evidence of glaucomatous visual field defects 1/2
Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
Measured: 2 years
Evidence of glaucomatous visual field defects 2/2
Visual field defects measured by Ocusweep test called Reaction Time Perimetry. Outcome measure is reaction time on multiple locations on the visual field. From this data, unseen locations are calculated.
Measured: 2 years
Contrast Sensitivity - Ocusweep
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Measured: 2 years
Visual Acuity- Ocusweep
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
Measured: 2 years
Visual Search - Ocusweep Neural
Measured in reaction time
Measured: 2 years
Memory guided saccades - Ocusweep Neural
Measured in reaction time
Measured: 2 years
Anti-saccades - Ocusweep Neural
Measured in reaction time
Measured: 2 years
Prosaccade - Ocusweep Neural
Measured in reaction time
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Dec 2017
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Ocuspecto Oy, European Commission
- Responsible party
- Sponsor
- Investigators
- Eija Vesti, Dr, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333096
- Sponsor's protocol ID
- T212/2017
- Status last verified
- Feb 2018
- First submitted
- 15 Aug 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Neurovisual Function in Patients With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03333096
- Acronym / sponsor ID
- T212/2017
- Keywords
- Glaucoma, Mild Cognitive Impairment, Ocusweep, Reaction Time, Neuropsychology, Dementia, Alzheimer's Disease, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Ocuspecto Oy, European Commission
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 6 Nov 2017 (actual)
- 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 aim of this study is to measure fitness to drive in patients with a visual and a cognitive impairment. To do so, Ocusweep is used in patients with glaucoma and Mild Cognitive Impairment. The participants will be divided over four groups; patients with glaucoma, patients with cognitive impairment, patients with both and a healthy control group. Differences in performance on Ocusweep in the four different groups of participants are expected. These effects may be related to fitness to drive, which is why those results will be compared to traditional neuropsychological measures of fitness to drive. the hypothesis of the current study is that the Ocusweep performance is related to performance on other measures of fitness to drive.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma and mild cognitive impairment | Other | Device: Ocusweep test battery, Diagnostic Test: Neuropsychological test batteryDevice: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Be at least 65 years old
- Fit into one of the four groups of participants
- No other eye diseases than glaucoma
- Still be able to and allowed to drive a car
- Be able to visit the Turku Driver's Clinic for testing
Key exclusion criteria (4 listed)
- A history of neurological disorders, depression or anxiety
- Motor problems
- Visual acuity less than 0.5
- Score over 6 in Geriatric Depression Scale questionnaire (GDS 15)
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 |
|---|---|---|
| Ocusweep test batteryOcusweep test battery to measure vision, visual system and cognitive performance including attention (Comparison of Ocusweep system to conventional neuropsychological test methods) (With the help of Ocusweep tests, information is obtained about the functioning of the whole visual system - from the ability of the eye to see to the efficiency of the brain to process visual information and the accuracy of eye movements) | Device | Glaucoma and mild cognitive impairment |
| Neuropsychological test batteryConventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed | Diagnostic test | Glaucoma and mild cognitive impairment |
Primary outcome
Perception speed
Time frame: 2 years
Measured by Ocusweep RTP-test
Evidence of cognitive impairment measured by MoCA-test
Time frame: 2 years
Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Evidence of impaired attentional ability - Cognitive profile
Time frame: 2 years
Measured by performing mazes. Unit of measure is seconds it takes to perform and number of errors.
Evidence of impaired Executive Functioning - Cognitive profile 1/2
Time frame: 2 years
Measured by the Trail Making Test. Unit of measure is seconds to perform the test, which will be converted in a percentile score.
Evidence of impaired Executive Functioning - Cognitive profile 2/2
Time frame: 2 years
Measured by the Trail Making Test. Unit of measure is errors made during the test.
Evidence of impaired Visuoconstructive abilities - Cognitive profile
Time frame: 2 years
Measured by the Benton Visual Retention Test. Unit of measure is number of correctly drawn designs (0-10)
Evidence of slow reaction time - Cognitive profile
Time frame: 2 years
Measured with Vienna Test System. Unit of measure is reaction time in ms. Results will be converted into percentile scores.
Evidence of impaired visual attention measured by UFOV-test - Cognitive Profile
Time frame: 2 years
Vision and visual attention measured with Useful Field of View. Unit of measure is milliseconds which is converted in group scores provided by UFOV.
Evidence of glaucomatous visual field defects 1/2
Time frame: 2 years
Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
Evidence of glaucomatous visual field defects 2/2
Time frame: 2 years
Visual field defects measured by Ocusweep test called Reaction Time Perimetry. Outcome measure is reaction time on multiple locations on the visual field. From this data, unseen locations are calculated.
Contrast Sensitivity - Ocusweep
Time frame: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Visual Acuity- Ocusweep
Time frame: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
Visual Search - Ocusweep Neural
Time frame: 2 years
Measured in reaction time
Memory guided saccades - Ocusweep Neural
Time frame: 2 years
Measured in reaction time
Anti-saccades - Ocusweep Neural
Time frame: 2 years
Measured in reaction time
Prosaccade - Ocusweep Neural
Time frame: 2 years
Measured in reaction time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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.
Eija Vesti, Dr principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocusweep test battery and Neuropsychological test battery in people with Glaucoma and Mild Cognitive Impairment, run by Turku University Hospital at 1 site in Finland.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iris Tigchelaar, Msc (+358 452162111, iris.i.tigchelaar@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception speed (time frame: 2 years). The study lists 16 primary outcomes in all. 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 19 Feb 2018; AzTrials last refreshed its copy on 29 Oct 2026.