Evaluation of the Performance and Safety of the S360 Medical Device Software.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Sensitivity (Se) and specificity (Sp)
Study Overview
Brief Summary
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).
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Sensitivity (Se) and specificity (Sp)
Time Frame: Day 0
Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement
Secondary Outcomes
- 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)