Assessing Neurovisual Function in Patients With Cognitive Impairment
Primary Purpose
Glaucoma, Mild Cognitive Impairment, Glaucoma and Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Ocusweep test battery
Neuropsychological test battery
Sponsored by
About this trial
This is an interventional screening trial for Glaucoma focused on measuring Glaucoma, Mild Cognitive Impairment, Ocusweep, Reaction Time, Neuropsychology, Dementia, Alzheimer's Disease, Brain Diseases
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Glaucoma and mild cognitive impairment
Arm Description
Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing
Outcomes
Primary Outcome Measures
Perception speed
Measured by Ocusweep RTP-test
Evidence of cognitive impairment measured by MoCA-test
Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Evidence of impaired attentional ability - Cognitive profile
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
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
Measured by the Trail Making Test. Unit of measure is errors made during the test.
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)
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.
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.
Evidence of glaucomatous visual field defects 1/2
Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
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.
Contrast Sensitivity - Ocusweep
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Visual Acuity- Ocusweep
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
Visual Search - Ocusweep Neural
Measured in reaction time
Memory guided saccades - Ocusweep Neural
Measured in reaction time
Anti-saccades - Ocusweep Neural
Measured in reaction time
Prosaccade - Ocusweep Neural
Measured in reaction time
Secondary Outcome Measures
Full Information
NCT ID
NCT03333096
First Posted
August 15, 2017
Last Updated
February 15, 2018
Sponsor
Turku University Hospital
Collaborators
Ocuspecto Oy, European Commission
1. Study Identification
Unique Protocol Identification Number
NCT03333096
Brief Title
Assessing Neurovisual Function in Patients With Cognitive Impairment
Official Title
Assessing Neurovisual Function in Patients With Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
Ocuspecto Oy, European Commission
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Mild Cognitive Impairment, Glaucoma and Mild Cognitive Impairment, Healthy
Keywords
Glaucoma, Mild Cognitive Impairment, Ocusweep, Reaction Time, Neuropsychology, Dementia, Alzheimer's Disease, Brain Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glaucoma and mild cognitive impairment
Arm Type
Other
Arm Description
Device: Ocusweep test battery Neuropsychological test battery
Ocusweep system compared to neuropsychological testing
Intervention Type
Device
Intervention Name(s)
Ocusweep test battery
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuropsychological test battery
Intervention Description
Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed
Primary Outcome Measure Information:
Title
Perception speed
Description
Measured by Ocusweep RTP-test
Time Frame
2 years
Title
Evidence of cognitive impairment measured by MoCA-test
Description
Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Time Frame
2 years
Title
Evidence of impaired attentional ability - Cognitive profile
Description
Measured by performing mazes. Unit of measure is seconds it takes to perform and number of errors.
Time Frame
2 years
Title
Evidence of impaired Executive Functioning - Cognitive profile 1/2
Description
Measured by the Trail Making Test. Unit of measure is seconds to perform the test, which will be converted in a percentile score.
Time Frame
2 years
Title
Evidence of impaired Executive Functioning - Cognitive profile 2/2
Description
Measured by the Trail Making Test. Unit of measure is errors made during the test.
Time Frame
2 years
Title
Evidence of impaired Visuoconstructive abilities - Cognitive profile
Description
Measured by the Benton Visual Retention Test. Unit of measure is number of correctly drawn designs (0-10)
Time Frame
2 years
Title
Evidence of slow reaction time - Cognitive profile
Description
Measured with Vienna Test System. Unit of measure is reaction time in ms. Results will be converted into percentile scores.
Time Frame
2 years
Title
Evidence of impaired visual attention measured by UFOV-test - Cognitive Profile
Description
Vision and visual attention measured with Useful Field of View. Unit of measure is milliseconds which is converted in group scores provided by UFOV.
Time Frame
2 years
Title
Evidence of glaucomatous visual field defects 1/2
Description
Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
Time Frame
2 years
Title
Evidence of glaucomatous visual field defects 2/2
Description
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.
Time Frame
2 years
Title
Contrast Sensitivity - Ocusweep
Description
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Time Frame
2 years
Title
Visual Acuity- Ocusweep
Description
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
Time Frame
2 years
Title
Visual Search - Ocusweep Neural
Description
Measured in reaction time
Time Frame
2 years
Title
Memory guided saccades - Ocusweep Neural
Description
Measured in reaction time
Time Frame
2 years
Title
Anti-saccades - Ocusweep Neural
Description
Measured in reaction time
Time Frame
2 years
Title
Prosaccade - Ocusweep Neural
Description
Measured in reaction time
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Tigchelaar, Msc
Phone
+358 452162111
Email
iris.i.tigchelaar@utu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Markku Leinonen, Dr
Phone
+358 40 5283644
Email
markku.leinonen@ocuspecto.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eija Vesti, Dr
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
Country
Finland
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Assessing Neurovisual Function in Patients With Cognitive Impairment
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