NCT05522595

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

April 19, 2023

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

August 23, 2022

Last Update Submit

April 18, 2023

Conditions

Binocular Vision DisorderBinocular Eye Movement DisorderOcular Motion; Disorder

Keywords

Eye trackerOrthoptics analysisNeuro-visuo-motor analysisEye movement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Accuracy of the S360's measured data

    Day 0

  • Repeatability of the S360's measured data

    Day 0

  • Reproducibility of the S360's measured data

    Day 0

  • Evaluation of the usefulness of the MDSW S360 in the current practice

    Day 0

  • Validation of the technical functionalities of the MDSW S360

    Day 0

  • +4 more secondary outcomes

Study Arms (1)

Standard of care arm

EXPERIMENTAL

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

Interventions

S360DEVICE

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.

Standard of care arm

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut des Sciences de la Vision

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sandra Maleysson

    Institut des Sciences de la Vision

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lionel Moiroud

CONTACT

(+33) 7 82 75 37 79lionel.moiroud@sierra-neurovision.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 31, 2022

Study Start

November 2, 2023

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

April 19, 2023

Record last verified: 2022-08

Locations

FR(1)