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Clinical Trials/NCT03333096
NCT03333096
Unknown
Not Applicable

Assessing Neurovisual Function in Patients With Cognitive Impairment

Turku University Hospital1 site in 1 country60 target enrollmentDecember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Turku University Hospital
Enrollment
60
Locations
1
Primary Endpoint
Perception speed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
January 1, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Perception speed

Time Frame: 2 years

Measured by Ocusweep RTP-test

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

Prosaccade - Ocusweep Neural

Time Frame: 2 years

Measured in reaction time

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 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 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.

Anti-saccades - Ocusweep Neural

Time Frame: 2 years

Measured in reaction time

Visual Acuity- Ocusweep

Time Frame: 2 years

Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.

Study Sites (1)

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