Assessing Neurovisual Function in Patients With Cognitive Impairment

NCT ID: NCT03333096

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-01-01

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.

Detailed Description

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Conditions

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Glaucoma Mild Cognitive Impairment Glaucoma and Mild Cognitive Impairment Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Glaucoma and mild cognitive impairment

Device: Ocusweep test battery Neuropsychological test battery

Ocusweep system compared to neuropsychological testing

Group Type OTHER

Ocusweep test battery

Intervention Type DEVICE

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)

Neuropsychological test battery

Intervention Type DIAGNOSTIC_TEST

Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed

Interventions

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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)

Intervention Type DEVICE

Neuropsychological test battery

Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed

Intervention Type DIAGNOSTIC_TEST

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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ocuspecto Oy

INDUSTRY

Sponsor Role collaborator

European Commission

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eija Vesti, Dr

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University Hospital

Turku, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Iris Tigchelaar, Msc

Role: CONTACT

+358 452162111

Markku Leinonen, Dr

Role: CONTACT

+358 40 5283644

Other Identifiers

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T212/2017

Identifier Type: -

Identifier Source: org_study_id

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