Assessing Neurovisual Function in Patients With Cognitive Impairment

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 Overview

• Status: Unknown
• Conditions: Glaucoma; Healthy; Mild Cognitive Impairment; Glaucoma and Mild Cognitive Impairment
• Intervention / Treatment: Device: Ocusweep test battery; Diagnostic test: Neuropsychological test battery

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iris Tigchelaar, Msc; Phone Number: +358 452162111; Email: iris.i.tigchelaar@utu.fi
• Study Contact Backup: Name: Markku Leinonen, Dr; Phone Number: +358 40 5283644; Email: markku.leinonen@ocuspecto.com

Study Locations

• Finland
  • Turku, Finland
    • Recruiting
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Glaucoma and mild cognitive impairment; Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing

Device: Ocusweep test battery; 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); Diagnostic test: Neuropsychological test battery; Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: European Commission; Ocuspecto Oy
• Investigators: Principal Investigator: Eija Vesti, Dr, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Alzheimer's Disease; Mild Cognitive Impairment; Dementia; Glaucoma; Neuropsychology; Brain Diseases; Reaction Time; Ocusweep
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Neurocognitive Disorders; Ocular Hypertension; Cognition Disorders; Glaucoma; Cognitive Dysfunction
• Other Study ID Numbers: T212/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No