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Assessing Neurovisual Function in Patients With Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333096
Recruitment Status : Unknown
Verified February 2018 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
Ocuspecto Oy
European Commission
Information provided by (Responsible Party):
Turku University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Mild Cognitive Impairment Glaucoma and Mild Cognitive Impairment Healthy Device: Ocusweep test battery Diagnostic Test: Neuropsychological test battery Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessing Neurovisual Function in Patients With Cognitive Impairment
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Perception speed [ Time Frame: 2 years ]
    Measured by Ocusweep RTP-test

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. 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.

  8. 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.

  9. Evidence of glaucomatous visual field defects 1/2 [ Time Frame: 2 years ]
    Narrowing of the visual field measured with Standard Automated Perimetry (SAP).

  10. 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.

  11. Contrast Sensitivity - Ocusweep [ Time Frame: 2 years ]
    Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.

  12. Visual Acuity- Ocusweep [ Time Frame: 2 years ]
    Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.

  13. Visual Search - Ocusweep Neural [ Time Frame: 2 years ]
    Measured in reaction time

  14. Memory guided saccades - Ocusweep Neural [ Time Frame: 2 years ]
    Measured in reaction time

  15. Anti-saccades - Ocusweep Neural [ Time Frame: 2 years ]
    Measured in reaction time

  16. Prosaccade - Ocusweep Neural [ Time Frame: 2 years ]
    Measured in reaction time


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333096


Contacts
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Contact: Iris Tigchelaar, Msc +358 452162111 iris.i.tigchelaar@utu.fi
Contact: Markku Leinonen, Dr +358 40 5283644 markku.leinonen@ocuspecto.com

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland
Sponsors and Collaborators
Turku University Hospital
Ocuspecto Oy
European Commission
Investigators
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Principal Investigator: Eija Vesti, Dr Turku University Hospital
More Information
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03333096    
Other Study ID Numbers: T212/2017
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Turku University Hospital:
Glaucoma
Mild Cognitive Impairment
Ocusweep
Reaction Time
 Neuropsychology
Dementia
Alzheimer's Disease
Brain Diseases
Additional relevant MeSH terms:
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Glaucoma
Cognitive Dysfunction
Ocular Hypertension
Eye Diseases
 Cognition Disorders
Neurocognitive Disorders
Mental Disorders