Assessing Neurovisual Function in Patients With Cognitive Impairment

NCT03333096 | Unknown

• 1 other identifier: T212/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Mild Cognitive Impairment; Glaucoma and Mild Cognitive Impairment; Healthy

Keywords

Glaucoma; Mild Cognitive Impairment; Ocusweep; Reaction Time; Neuropsychology; Dementia; Alzheimer's Disease; Brain Diseases

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (1)

Glaucoma and mild cognitive impairment

OTHER

Device: Ocusweep test battery Neuropsychological test battery Ocusweep system compared to neuropsychological testing

Device: Ocusweep test battery; Diagnostic Test: Neuropsychological test battery

Interventions

Ocusweep test battery 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)

Glaucoma and mild cognitive impairment

Neuropsychological test battery DIAGNOSTIC_TEST

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

Glaucoma and mild cognitive impairment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Turku University Hospital: lead
• Ocuspecto Oy: collaborator
• European Commission: collaborator

Study Sites (1)

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Glaucoma; Cognitive Dysfunction; Dementia; Alzheimer Disease; Brain Diseases

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Eija Vesti, Dr

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Tigchelaar, Msc

CONTACT

+358 452162111; iris.i.tigchelaar@utu.fi

Markku Leinonen, Dr

CONTACT

+358 40 5283644; markku.leinonen@ocuspecto.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: November 6, 2017
• Study Start: December 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

FI (1)