Performance and Safety Evaluation of the S360 Medical Device Software.

Binocular Vision Disorder Clinical Trial

— ArgoS360  

Official title:

Evaluation of the Performance and Safety of the S360 Medical Device Software.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05522595
• Other study ID #: S360 IC-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: January 2, 2024

Study information

• Verified date: August 2022
• Source: Sierra Neurovision
• Contact: Lionel Moiroud
• Phone: (+33) 7 82 75 37 79
• Email: lionel.moiroud[@]sierra-neurovision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Binocular Vision Disorder
• Disease
• Movement Disorders
• Ocular Motility Disorders
• Strabismus
• Vision Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Institut des Sciences de la Vision	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Sierra Neurovision	CEISO, Institut des Sciences de la Vision

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 0
Secondary	Accuracy of the S360's measured data	Error rate calculation of the S360's measured data	Day 0
Secondary	Repeatability of the S360's measured data	Coefficient of variation calculation of the S360's measured data	Day 0
Secondary	Reproducibility of the S360's measured data	The reproducibility coefficient of the S360's measured data	Day 0
Secondary	Evaluation of the usefulness of the MDSW S360 in the current practice	Rate of positive feedback estimation	Day 0
Secondary	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	Day 0
Secondary	Safety : Adverse events	Incidence of the medical device's related-adverse events estimation	Day 0
Secondary	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	Day 0
Secondary	Comparison of the duration of the two procedure	Average duration of the two procedures (S360 vs Standard of care)	Day 0
Secondary	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	Day 0