Evaluation of the Performance and Safety of the S360 Medical Device Software.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity (Se) and specificity (Sp)
研究概览
简要总结
The aim of this interventional, cross-sectional study is to evaluate the performance and the safety of the medical device software S360. This clinical investigation is performed in order to demonstrate the conformity of the medical device, when operating under the normal conditions of its intended use, in accordance with the General Safety and Performance Requirements pertaining to clinical evaluation of the device regarding the Medical Device Regulation (MDR) 2017/745 (EU).
详细描述
Background:
Accurate detection and interpretation of eye movement abnormalities often guides differential diagnosis and discussions on prognosis. Therefore, adequate diagnosis permits to direct treatment of disabling visual symptoms and signs. A comprehensive clinical eye movement examination is high yield from a diagnostic standpoint; however, skilful recording and quantification of eye movements can increase detection of subclinical deficits, confirm clinical suspicions, guide therapeutics, and generate expansive research opportunities.
Recently, many technologies, allowing objective measurements, have been developed. The most commonly used eye movement measurement technique is the high frequency video camera (Eye tracker).
In this context, SIERRA NEUROVISION has developed the S360, a medical device software using the infrared video-oculography technology. It is intended to collect data for orthoptics and neuro-visuo-motor analysis. It records the patient's eye movements, displays the patient's scoring next to normative values retrieved from literature and widely used in the current practice.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 6 years old requiring an orthoptic or neuro-visual assessment in order to assess the effectiveness of oculomotor skills;
- •Both gender; male and female
- •Symptomatic or non-symptomatic patient;
- •Affiliated person or beneficiary of a social security scheme,
- •Free, informed and written consent signed by the participant and the investigator for adults or by parents/legal representative for patients aged from 6 to 17years old
排除标准
- •Visual acuity below 5/10 not improvable
- •Patient with a head injury;
- •Patient with ocular injury;
- •Patient with diagnosed serious pathologies that may interfere with the study measurements;
- •Patient with medical treatment that may interfere with the study
- •Patient with hypersensitivity to electronic devices;
- •Non-cooperative patient (e.g. restless patient);
- •Non-French speaker patient;
- •Patient unable to understand study procedures;
- •Subject who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection;
- •Patient refusing to participate in the study.
结局指标
主要结局
Sensitivity (Se) and specificity (Sp)
时间窗: Day 0
Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement
次要结局
- Reproducibility of the S360's measured data(Day 0)
- Accuracy of the S360's measured data(Day 0)
- Evaluation of the usefulness of the MDSW S360 in the current practice(Day 0)
- Comparison of the duration of the two procedure(Day 0)
- Repeatability of the S360's measured data(Day 0)
- Validation of the technical functionalities of the MDSW S360(Day 0)
- Safety : Adverse events(Day 0)
- Operator's comfort of using the medical device S360(Day 0)
- Patient satisfaction(Day 0)