Assessing Neurovisual Function in Patients With Cognitive Impairment
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perception speed
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Glaucoma and mild cognitive impairment
Device: Ocusweep test battery Neuropsychological test battery
Ocusweep system compared to neuropsychological testing
干预措施: Ocusweep test battery (Device)
Glaucoma and mild cognitive impairment
Device: Ocusweep test battery Neuropsychological test battery
Ocusweep system compared to neuropsychological testing
干预措施: Neuropsychological test battery (Diagnostic Test)
结局指标
主要结局
Perception speed
时间窗: 2 years
Measured by Ocusweep RTP-test
Visual Search - Ocusweep Neural
时间窗: 2 years
Measured in reaction time
Memory guided saccades - Ocusweep Neural
时间窗: 2 years
Measured in reaction time
Prosaccade - Ocusweep Neural
时间窗: 2 years
Measured in reaction time
Evidence of glaucomatous visual field defects 1/2
时间窗: 2 years
Narrowing of the visual field measured with Standard Automated Perimetry (SAP).
Evidence of cognitive impairment measured by MoCA-test
时间窗: 2 years
Measured with Montreal Cognitive Assessment. Outcome measure is a score between 0 and 30.
Evidence of impaired attentional ability - Cognitive profile
时间窗: 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
时间窗: 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
时间窗: 2 years
Measured by the Trail Making Test. Unit of measure is errors made during the test.
Evidence of impaired Visuoconstructive abilities - Cognitive profile
时间窗: 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
时间窗: 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
时间窗: 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 2/2
时间窗: 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
时间窗: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score.
Anti-saccades - Ocusweep Neural
时间窗: 2 years
Measured in reaction time
Visual Acuity- Ocusweep
时间窗: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score.
次要结局
未报告次要终点