Comparison of Non-mydriatic Camera Systems for Screening and Follow-up Examinations -Focused on the Retinal Vessel Situation- in the Population of a Female Health Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 4
- 主要终点
- Image Quality
研究概览
简要总结
- To compare quality and usability of images taken by two different camera-systems without dilating the pupil.
- To compare the retinal vessel diameters based on the images of to different camera-systems.
- To detect changes in retinal vessel diameters while pregnancy and after delivery.
详细描述
- To compare quality and usability of images taken by two different camera-systems without dilating the pupil.
Quality means in this content that images cover the planned region of interest and images should be sharp and good illuminated to see details for medical reading of retinal findings. 2. To compare the retinal vessel diameters based on the images of to different camera-systems.
The diameters of arteries and veins are planned to be measured with an automated software algorithm. Are there differences in the calculated results between the two used camera devices? 3. To detect changes in retinal vessel diameters while pregnancy and after delivery.
Are there detectable changes of the retinal findings between the images taken before and after delivery (e.g. bleeding, edema, vessel tortuosity)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent
- •age >18 years
- •pregnancy (only group 2)
排除标准
- •limited ability for agreement
- •heavy tremble
- •reduced general condition
- •known epilepsy
结局指标
主要结局
Image Quality
时间窗: 12 to 16 month
Visit 1 and Visit 2 (for group 2) Evaluating of image quality for each camera-system
次要结局
- Retinal Pathologies(12 to 16 month)
- Differences Perinatal(12 to 16 month)
研究者
Dr. Martin Leitritz
Dr. med. Martin A. Leitritz
University Hospital Tuebingen