Comparison Between Two Wide-field Imaging Systems on the Extent of Retinal Periphery Area Viewing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- difference in retinal periphery viewing between the two devices
研究概览
简要总结
Fundus imaging has become an integral tool in retinal diagnosis. Although single-field fundus photography covers a vital region of the retina, it leaves a large portion of the periphery undiscovered.
Ultra-wide-field imaging systems allowed for visualization of peripheral perfusion abnormalities in myopic eyes that were previously unknown.
In Austria, there are two different wide-field imaging systems available. The first device on the market was the Optos (Optos PLC, Dunfermline, UK) and several years later the Clarus 500 (Carl Zeiss, Meditec AG, Jena, Germany) was introduced.
详细描述
While both of the studied imaging systems have the possibility of a 200° view of the retina, we would asses if the differences between the two devices affect the extent of retinal periphery view and if ocular ametropies which come with different retinal pathologies would affect the retinal periphery assessment.
Aim: To compare two CE-marked imaging systems concerning the extent of retinal periphery area viewing.
We would like to perform a prospective observational study that would include patients divided into three groups: myopic patients, hyperopic and emmetropic patients.
Fundus photography will be performed using two ultra-wide-field imaging systems (Optos, Daytona, Optos PLC, Dunfermline, UK and Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany), performed by the same investigator.
All images with sufficient quality will be exported and saved to hard-disk. The difference in periphery view will be investigated as follows: two retinal photos for each patient will be imported into Photoshop CS6 image-editing system (Adobe, version 13.0.0) where the anatomical landmarks will be matched for each image and the borders will be compared to see if there are differences in retinal periphery area viewing between the two devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over 21 years old
- •Myopic (at least -5.00Dsph), hyperopic (over +3.00Dsph) and emmetropic patients
- •Written informed consent prior to any study specific action.
排除标准
- •Extensive cataract or severe corneal scaring that would affect image quality
- •Fixation problems, nystagmus
- •pregnancy- for women in reproductive age a pregnancy test will be performed.
结局指标
主要结局
difference in retinal periphery viewing between the two devices
时间窗: 7 months
Extent of retinal periphery area viewing (the difference in periphery area between the two devices). Images of the same patients will be compared to determine the degree of periphery viewing for the two devices.
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of Ophthalmology Department, principal investigator
Vienna Institute for Research in Ocular Surgery