Performance and Safety Evaluation of the S360 Medical Device Software.
- Conditions
- Binocular Eye Movement DisorderBinocular Vision DisorderOcular Motion; Disorder
- Interventions
- Device: S360
- Registration Number
- NCT05522595
- Lead Sponsor
- Sierra Neurovision
- 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:
The study is cross-sectional, interventional, open label, single-arm, comparative and single-center study.
This study is a pre-marketing, confirmatory research which is performed in order to evaluate the performance and the safety of S360 MDSW compared to the standard of care procedure.
Intervention:
As the current study is cross-sectional, no follow-up visits related to the study are planned. All study procedures will be carried out during the inclusion visit which will take place during the patient's medical visit as part as his/her standard of care.
The study will be conducted in two parts:
Part 1 : standard of care measurements.
* CISS (Screening for convergence insufficiency) questionnaire completion
* Eye movements measurements using the standard tools used by the orthoptist (a prism bar, a penlight and a video projector, etc).
A first diagnosis based on the interpretation of the results provided by the standard of care measurements will be established by a first evaluator (orthoptist).
Part 2: S360 measurements
- Eye movements measurements using the medical device software S360. A second diagnosis based on the interpretation of the outcomes provided by the MDSW S360 will be established by a second evaluator (orthoptist).
The two measurements procedures are performed in two different examination rooms by two different operators. The diagnoses are established by two different investigators (orthoptist).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard of care arm S360 The patient is his own comparator. During the intervention, the eyes movements measurements will be performed using the standard of care and the medical device S360.
- Primary Outcome Measures
Name Time Method Sensitivity (Se) and specificity (Sp) Day 0 Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement
- Secondary Outcome Measures
Name Time Method Accuracy of the S360's measured data Day 0 Error rate calculation of the S360's measured data
Reproducibility of the S360's measured data Day 0 The reproducibility coefficient of the S360's measured data
Evaluation of the usefulness of the MDSW S360 in the current practice Day 0 Rate of positive feedback estimation
Comparison of the duration of the two procedure Day 0 Average duration of the two procedures (S360 vs Standard of care)
Repeatability of the S360's measured data Day 0 Coefficient of variation calculation of the S360's measured data
Validation of the technical functionalities of the MDSW S360 Day 0 Calculation of the :
* Rate of successful outcomes transmission
* Rate of successful display of outcomes measurement
* Rate of successful report generation
* Rate of successful report transmissionSafety : Adverse events Day 0 Incidence of the medical device's related-adverse events estimation
Operator's comfort of using the medical device S360 Day 0 Operator's comfort of using the medical device and the headset survey Comfort level will be expressed by the rate of satisfaction: Higher rate means a better Comfort
Patient satisfaction Day 0 Patient's satisfaction level by using a satisfaction survey Satisfaction level will be expressed by the rate of satisfaction: Higher rate means a better satisfaction
Trial Locations
- Locations (1)
Institut des Sciences de la Vision
🇫🇷Saint-Étienne, France