Assessing Neurovisual Function in Patients With Cognitive Impairment
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|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
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|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Perception speed [ Time Frame: 2 years ]Measured by Ocusweep RTP-test
- 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.
- 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.
- 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.
- 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.
- 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)
- 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.
- 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.
- Evidence of glaucomatous visual field defects 1/2 [ Time Frame: 2 years ]Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
- 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.
- Contrast Sensitivity - Ocusweep [ Time Frame: 2 years ]Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
- Visual Acuity- Ocusweep [ Time Frame: 2 years ]Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
- Visual Search - Ocusweep Neural [ Time Frame: 2 years ]Measured in reaction time
- Memory guided saccades - Ocusweep Neural [ Time Frame: 2 years ]Measured in reaction time
- Anti-saccades - Ocusweep Neural [ Time Frame: 2 years ]Measured in reaction time
- Prosaccade - Ocusweep Neural [ Time Frame: 2 years ]Measured in reaction time
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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)
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
|Contact: Iris Tigchelaar, Msc||+358 firstname.lastname@example.org|
|Contact: Markku Leinonen, Dr||+358 40 email@example.com|
|Turku University Hospital||Recruiting|
|Principal Investigator:||Eija Vesti, Dr||Turku University Hospital|
|Responsible Party:||Turku University Hospital|
|Other Study ID Numbers:||
|First Posted:||November 6, 2017 Key Record Dates|
|Last Update Posted:||February 19, 2018|
|Last Verified:||February 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Mild Cognitive Impairment