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Performance and Safety Evaluation of the S360 Medical Device Software.

NCT05522595 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-04-19

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Institut des Sciences de la Vision

    collaborator UNKNOWN

  • CEISO

    collaborator INDUSTRY

  • Sierra Neurovision

    lead INDUSTRY

Principal Investigators

  • Sandra Maleysson · Institut des Sciences de la Vision

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2024-01-02
Completion
2024-01-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05522595 on ClinicalTrials.gov