Performance and Safety Evaluation of the S360 Medical Device Software.

NCT ID: NCT05522595

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-01-02

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).

Conditions

Binocular Vision Disorder; Binocular Eye Movement Disorder; Ocular Motion; Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

S360

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut des Sciences de la Vision

UNKNOWN

Sponsor Role: collaborator

CEISO

INDUSTRY

Sponsor Role: collaborator

Sierra Neurovision

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Maleysson

Role: PRINCIPAL_INVESTIGATOR

Institut des Sciences de la Vision

Locations

Institut des Sciences de la Vision

Saint-Etienne, , France

Countries

France

Central Contacts

Lionel Moiroud

Role: CONTACT

lionel.moiroud@sierra-neurovision.com

(+33) 7 82 75 37 79

Facility Contacts

Sandra Maleysson

Role: primary

Other Identifiers

S360 IC-01

Identifier Type: -

Identifier Source: org_study_id