Assessing Neurovisual Function in Patients With Cognitive Impairment

Study Overview
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Brief Summary
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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.

Official Title
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Assessing Neurovisual Function in Patients With Cognitive Impairment

Conditions
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Glaucoma, Mild Cognitive Impairment, Glaucoma and Mild Cognitive Impairment, Healthy

Intervention / Treatment
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* Device: Ocusweep test battery
* Diagnostic Test: Neuropsychological test battery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Glaucoma and mild cognitive impairment<br>Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing | Device: Ocusweep test battery<br>* 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)<br>Diagnostic Test: Neuropsychological test battery<br>* Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception speed | Measured by Ocusweep RTP-test | 2 years | 
| Evidence of cognitive impairment measured by MoCA-test | Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30. | 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. | 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. | 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. | 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) | 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. | 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. | 2 years | 
| Evidence of glaucomatous visual field defects 1/2 | Narrowing of the visual field measured with Standard Automated Perimetry (SAP). | 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. | 2 years | 
| Contrast Sensitivity - Ocusweep | Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score. | 2 years | 
| Visual Acuity- Ocusweep | Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score. | 2 years | 
| Visual Search - Ocusweep Neural | Measured in reaction time | 2 years | 
| Memory guided saccades - Ocusweep Neural | Measured in reaction time | 2 years | 
| Anti-saccades - Ocusweep Neural | Measured in reaction time | 2 years | 
| Prosaccade - Ocusweep Neural | Measured in reaction time | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Mild Cognitive Impairment, Ocusweep, Reaction Time, Neuropsychology, Dementia, Alzheimer's Disease, Brain Diseases