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Clinical Trials/NCT05522595
NCT05522595UnknownNot Applicable

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

Sierra Neurovision2 sites in 1 country200 target enrollmentStarted: November 2, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Sensitivity (Se) and specificity (Sp)

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
6 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Sensitivity (Se) and specificity (Sp)

Time Frame: Day 0

Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement

Secondary Outcomes

  • Reproducibility of the S360's measured data(Day 0)
  • Accuracy of the S360's measured data(Day 0)
  • Evaluation of the usefulness of the MDSW S360 in the current practice(Day 0)
  • Comparison of the duration of the two procedure(Day 0)
  • Repeatability of the S360's measured data(Day 0)
  • Validation of the technical functionalities of the MDSW S360(Day 0)
  • Safety : Adverse events(Day 0)
  • Operator's comfort of using the medical device S360(Day 0)
  • Patient satisfaction(Day 0)

Investigators

Sponsor
Sierra Neurovision
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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