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Assessing Neurovisual Function in Patients With Cognitive Impairment

Assessing Neurovisual Function in Patients With Cognitive Impairment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03333096
Enrollment
60
Registered
2017-11-06
Start date
2017-12-01
Completion date
2019-01-01
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DEVICEOcusweep 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)

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

Sponsors

Ocuspecto Oy
CollaboratorINDUSTRY
European Commission
CollaboratorOTHER
Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Perception speed2 yearsMeasured by Ocusweep RTP-test
Evidence of cognitive impairment measured by MoCA-test2 yearsMeasured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Evidence of impaired attentional ability - Cognitive profile2 yearsMeasured by performing mazes. Unit of measure is seconds it takes to perform and number of errors.
Evidence of impaired Executive Functioning - Cognitive profile 1/22 yearsMeasured by the Trail Making Test. Unit of measure is seconds to perform the test, which will be converted in a percentile score.
Evidence of impaired Executive Functioning - Cognitive profile 2/22 yearsMeasured by the Trail Making Test. Unit of measure is errors made during the test.
Evidence of impaired Visuoconstructive abilities - Cognitive profile2 yearsMeasured by the Benton Visual Retention Test. Unit of measure is number of correctly drawn designs (0-10)
Evidence of slow reaction time - Cognitive profile2 yearsMeasured with Vienna Test System. Unit of measure is reaction time in ms. Results will be converted into percentile scores.
Evidence of impaired visual attention measured by UFOV-test - Cognitive Profile2 yearsVision and visual attention measured with Useful Field of View. Unit of measure is milliseconds which is converted in group scores provided by UFOV.
Evidence of glaucomatous visual field defects 1/22 yearsNarrowing of the visual field measured with Standard Automated Perimetry (SAP).
Evidence of glaucomatous visual field defects 2/22 yearsVisual 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.
Contrast Sensitivity - Ocusweep2 yearsEvidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Visual Acuity- Ocusweep2 yearsEvidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
Visual Search - Ocusweep Neural2 yearsMeasured in reaction time
Memory guided saccades - Ocusweep Neural2 yearsMeasured in reaction time
Anti-saccades - Ocusweep Neural2 yearsMeasured in reaction time
Prosaccade - Ocusweep Neural2 yearsMeasured in reaction time

Countries

Finland

Contacts

Primary ContactIris Tigchelaar, Msc
iris.i.tigchelaar@utu.fi+358 452162111
Backup ContactMarkku Leinonen, Dr
markku.leinonen@ocuspecto.com+358 40 5283644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026