Assessing Neurovisual Function in Patients With Cognitive Impairment

Healthy Clinical Trial

Official title:

Assessing Neurovisual Function in Patients With Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03333096
• Other study ID #: T212/2017
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2017
• Last updated: February 15, 2018
• Start date: December 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2018
• Source: Turku University Hospital
• Contact: Iris Tigchelaar, Msc
• Phone: +358 452162111
• Email: iris.i.tigchelaar[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Glaucoma
• Glaucoma and Mild Cognitive Impairment
• Healthy
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	European Commission, Ocuspecto Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception speed	Measured by Ocusweep RTP-test	2 years
Primary	Evidence of cognitive impairment measured by MoCA-test	Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Evidence of glaucomatous visual field defects 1/2	Narrowing of the visual field measured with Standard Automated Perimetry (SAP).	2 years
Primary	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
Primary	Contrast Sensitivity - Ocusweep	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.	2 years
Primary	Visual Acuity- Ocusweep	Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.	2 years
Primary	Visual Search - Ocusweep Neural	Measured in reaction time	2 years
Primary	Memory guided saccades - Ocusweep Neural	Measured in reaction time	2 years
Primary	Anti-saccades - Ocusweep Neural	Measured in reaction time	2 years
Primary	Prosaccade - Ocusweep Neural	Measured in reaction time	2 years