Clinical trial NCT05522595: Performance and Safety Evaluation of the S360 Medical Device Software.
Official title: Evaluation of the Performance and Safety of the S360 Medical Device Software.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Binocular Vision Disorder
Binocular Eye Movement Disorder
Ocular Motion; Disorder
Keywords: Eye tracker
Orthoptics analysis
Neuro-visuo-motor analysis
Eye movement
Lead sponsor: Sierra Neurovision
Sponsor class: INDUSTRY
Collaborators: name: Institut des Sciences de la Vision
name: CEISO
First posted: 2022-08-31
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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.

Primary outcomes:
measure: Sensitivity (Se) and specificity (Sp)
timeFrame: Day 0
Secondary outcomes:
measure: Accuracy of the S360's measured data
timeFrame: Day 0
measure: Repeatability of the S360's measured data
timeFrame: Day 0
measure: Reproducibility of the S360's measured data
timeFrame: Day 0
measure: Evaluation of the usefulness of the MDSW S360 in the current practice
timeFrame: Day 0
measure: Validation of the technical functionalities of the MDSW S360
timeFrame: Day 0
measure: Safety : Adverse events
timeFrame: Day 0
measure: Operator's comfort of using the medical device S360
timeFrame: Day 0
measure: Comparison of the duration of the two procedure
timeFrame: Day 0
measure: Patient satisfaction
timeFrame: Day 0
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Institut des Sciences de la Vision
Study officials:
affiliation: Institut des Sciences de la Vision
name: Sandra Maleysson
role: PRINCIPAL_INVESTIGATOR
References: