Performance and Safety Evaluation of the S360 Medical Device Software. (ArgoS360)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Binocular Vision Disorder; Binocular Eye Movement Disorder; Ocular Motion; Disorder
• Intervention / Treatment: Device: S360

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lionel Moiroud; Phone Number: (+33) 7 82 75 37 79; Email: lionel.moiroud@sierra-neurovision.com

Study Locations

• France
  • Saint-Étienne, France, 42100
    • Institut des Sciences de la Vision
    • Contact: Sandra Maleysson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Standard of care arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sierra Neurovision
• Collaborators: CEISO; Institut des Sciences de la Vision
• Investigators: Principal Investigator: Sandra Maleysson, Institut des Sciences de la Vision

Study record dates

Study Major Dates

• Study Start (Anticipated): November 2, 2023
• Primary Completion (Anticipated): January 2, 2024
• Study Completion (Anticipated): January 2, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Eye movement; Eye tracker; Orthoptics analysis; Neuro-visuo-motor analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Disease; Strabismus; Movement Disorders; Vision Disorders; Ocular Motility Disorders
• Other Study ID Numbers: S360 IC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No