An interventional study of S360 in Binocular Vision Disorder, Binocular Eye Movement Disorder and Ocular Motion; Disorder, sponsored by Sierra Neurovision. Status unknown at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Sierra Neurovision · Not applicable, Interventional, and Other
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).
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.
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
The two measurements procedures are performed in two different examination rooms by two different operators. The diagnoses are established by two different investigators (orthoptist).
320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.
This study's planned enrollment of 200 is above the median of 46 across 180 interventional studies indexed under Movement Disorders.
Browse Movement Disorders studies →This is the only study on the registry with Sierra Neurovision as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: S360
In the first part of the intervention, after the CISS questionnaire completion by the patient, participant's eyes movements measurement will be performed using the reference procedure (standard of care). A first diagnosis is established according to the interpretation of the results by a first evaluator. In the second part of the intervention, the participant's eyes movements will be measured using the medical device S360. A second diagnosis is established according to the interpretation of the software's displayed data by a second evaluator.
Sensitivity (Se) and specificity (Sp)
Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement
Time frame: Day 0
Accuracy of the S360's measured data
Error rate calculation of the S360's measured data
Time frame: Day 0
Repeatability of the S360's measured data
Coefficient of variation calculation of the S360's measured data
Time frame: Day 0
Reproducibility of the S360's measured data
The reproducibility coefficient of the S360's measured data
Time frame: Day 0
Evaluation of the usefulness of the MDSW S360 in the current practice
Rate of positive feedback estimation
Time frame: Day 0
Validation of the technical functionalities of the MDSW S360
Calculation of the : * Rate of successful outcomes transmission * Rate of successful display of outcomes measurement * Rate of successful report generation * Rate of successful report transmission
Time frame: Day 0
Safety : Adverse events
Incidence of the medical device's related-adverse events estimation
Time frame: Day 0
Operator's comfort of using the medical device S360
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
Time frame: Day 0
Comparison of the duration of the two procedure
Average duration of the two procedures (S360 vs Standard of care)
Time frame: Day 0
Patient satisfaction
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
Time frame: Day 0
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.