Assessing Neurovisual Function in Patients With Cognitive Impairment

Not Applicable

• Conditions: Glaucoma and Mild Cognitive Impairment; Healthy; Glaucoma; Mild Cognitive Impairment
• Interventions: Device: Ocusweep test battery; Diagnostic Test: Neuropsychological test battery

• Registration Number: NCT03333096
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-12-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-15
• Last Update Posted: 2018-02-19
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glaucoma and mild cognitive impairment	Ocusweep test battery	Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing
Glaucoma and mild cognitive impairment	Neuropsychological test battery	Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing

Primary Outcome Measures

Name	Time	Method
Perception speed	2 years	Measured by Ocusweep RTP-test
Visual Search - Ocusweep Neural	2 years	Measured in reaction time
Memory guided saccades - Ocusweep Neural	2 years	Measured in reaction time
Prosaccade - Ocusweep Neural	2 years	Measured in reaction time
Evidence of cognitive impairment measured by MoCA-test	2 years	Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Evidence of impaired attentional ability - Cognitive profile	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	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	2 years	Measured by the Trail Making Test. Unit of measure is errors made during the test.
Evidence of impaired Visuoconstructive abilities - Cognitive profile	2 years	Measured by the Benton Visual Retention Test. Unit of measure is number of correctly drawn designs (0-10)
Evidence of glaucomatous visual field defects 1/2	2 years	Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
Evidence of slow reaction time - Cognitive profile	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	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 2/2	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	2 years	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Anti-saccades - Ocusweep Neural	2 years	Measured in reaction time
Visual Acuity- Ocusweep	2 years	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland