Evaluation of Visual Function and Driving Health Using Ocusweep in Patients Suffering From Wet Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 主要终点
- Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
研究概览
简要总结
The aim is to study the use of Ocusweep system especially in driving health evaluation and compare the results produced by Ocusweep system to those of conventional devices. The main focus is in patients suffering from wet age-related macular degeneration. The study aims to find out how frequently these patients do not meet the European Union health criteria of safe driving and how Ocusweep finds these patients from a population of patients being treated in a busy medical retina clinic. The tests of Ocusweep system are compared against conventional visual field tests, contrast sensitivity tests, visual acuity tests and tests showing anatomical changes related to wet age-related macular degeneration (optical coherence tomography, fundus photography and fluorescein or indocyanine green angiography).
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Macular degeneration or other diagnosed or suspected macular disease
排除标准
- •Pregnancy
- •Mental disorder
- •Dementia and Alzheimers disease
- •Prisoners
结局指标
主要结局
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by absolute scotoma in central visual field
时间窗: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by narrowing of peripheral visual field
时间窗: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by central visual field testing
时间窗: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in visual acuity scores
时间窗: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results acquired by peripheral visual field testing
时间窗: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by peripheral visual field testing
时间窗: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by visual acuity score
时间窗: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in visual acuity scores
时间窗: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results acquired by central visual field testing
时间窗: 2 years
Evidence that Ocusweep finds patients not meeting health criteria for driving, measured by contrast sensitivity score
时间窗: 2 years
Evidence of whether Ocusweep is comparable to conventional methods or not, by comparison of results in contrast sensitivity score
时间窗: 4 years
Evidence which (Ocusweep or ophthalmologist) is better in finding patients not meeting health criteria for driving, by comparison of results in contrast sensitivity score
时间窗: 2 years
次要结局
未报告次要终点
研究者
Vesa Aaltonen
Consultant in Ophthalmology
Turku University Hospital