A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) Remote Digital Slit Lamp and a the Topcon SL-D2 With DC-4 Digital Attachment (Predicate Device).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Identification of Pathology
研究概览
简要总结
A clinical study has been identified as a requirement for the RDSL (Theia). This study involves a clinical comparison of the imaging from the RDSL with that of a predicate device.
The clinical evaluation showed that there remains some residual risk in the practitioner's ability to use the imaging from the RDSL to detect pathologies at the same level as when using the imaging function on a predicate device.
The aim of this comparative study is to determine the degree, if any, of difference in using images captured from the RDSL for clinical inspection of pathologies, when compared to images captured from a predicate device.
Due to the involvement of real patients during the study, ethics approval was sought prior to commencement. This study is limited to the clinical benefits of the device.
An additional Human factors study has been conducted to assess the useability of the device Images were taken of healthy eyes and eyes with pathology (with images of several pathologies from each major pathology group to give a full range) on both the predicate device, and the RDSL.
详细描述
Methodology
Overview Images were taken of 14 healthy eyes and 35 unhealthy eyes containing a range of pathologies on both the predicate device and the THEIA. The pathologies to be imaged have been carefully selected using data from the clinical evaluation, and further investigation, to ensure that all aspects of the imaging systems and ocular structures are included.
The images were taken on compliant patients in a real-world setting.
Device Selection Device Type:AC-powered remote enabled slit-lamp Manufacturer:Eyoto Product Number:THEIA (3-008-0001-03)
Intended Use:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy eye or ocular pathology
排除标准
- •No exclusion other than age as above
结局指标
主要结局
Identification of Pathology
时间窗: Within 1 week after data collection
% accuracy of identification of pathology shown or healthy eye. Images reviewed via online from.
Diagnostic Confidence
时间窗: Within 1 week after data collection
How confident the practitioner is in respect of their identification of a pathology from image on a scale of 1-5, with 5 being completely confident and 1 being not confident. Images reviewed via online from.
Image Clarity
时间窗: Within 1 week after data collection
The rating of clarity of image by the practitioner on a scale of 1-5, with 5 being excellent clarity and 1 being low clarity. Images reviewed via online from.
次要结局
未报告次要终点