Binocular Vision DisorderArgoS360NCT05522595
Performance and Safety Evaluation of the S360 Medical Device Software.
A study testing S360 in people with Binocular Vision Disorder and Binocular Eye Movement Disorder, run by Sierra Neurovision at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Binocular Vision Disorder, Binocular Eye Movement Disorder, Ocular Motion; Disorder
- What is being tested?
- S360
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2023to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut des Sciences de la Vision
Saint-Etienne, 42100
Sandra Maleysson
About this study
Official title: Evaluation of the Performance and Safety of the S360 Medical Device Software.
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).
Read the 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).
- Being tested
- S360
- Keywords
- Eye tracker, Orthoptics analysis, Neuro-visuo-motor analysis, Eye movement
- Medical subject headings
- Esotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: S360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (9)
Accuracy of the S360's measured data
Error rate calculation of the S360's measured data
Measured: Day 0
Repeatability of the S360's measured data
Coefficient of variation calculation of the S360's measured data
Measured: Day 0
Reproducibility of the S360's measured data
The reproducibility coefficient of the S360's measured data
Measured: Day 0
Evaluation of the usefulness of the MDSW S360 in the current practice
Rate of positive feedback estimation
Measured: Day 0
Validation of the technical functionalities of the MDSW S360
Calculation of the :
- Rate of successful outcomes transmission
- Rate of successful display of outcomes measurement
- Rate of successful report generation
- Rate of successful report transmission
Measured: Day 0
Safety : Adverse events
Incidence of the medical device's related-adverse events estimation
Measured: Day 0
Operator's comfort of using the medical device S360
Operator's comfort of using the medical device and the headset survey Comfort level will be expressed by the rate of satisfaction: Higher rate means a better Comfort
Measured: Day 0
Comparison of the duration of the two procedure
Average duration of the two procedures (S360 vs Standard of care)
Measured: Day 0
Patient satisfaction
Patient's satisfaction level by using a satisfaction survey Satisfaction level will be expressed by the rate of satisfaction: Higher rate means a better satisfaction
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start2 Nov 2023 (estimated)
- Primary completion2 Jan 2024 (estimated)
- Study completion2 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binocular Vision DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Neurovision
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut des Sciences de la Vision, CEISO
- Responsible party
- Sponsor
- Investigators
- Sandra Maleysson, Principal investigator, Institut des Sciences de la Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522595
- Sponsor's protocol ID
- S360 IC-01
- Acronym
- ArgoS360
- Status last verified
- Aug 2022
- First submitted
- 23 Aug 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of the S360 Medical Device Software.
- ClinicalTrials.gov ID
- NCT05522595
- Acronym / sponsor ID
- ArgoS360 / S360 IC-01
- Keywords
- Eye tracker, Orthoptics analysis, Neuro-visuo-motor analysis, Eye movement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sierra NeurovisionIndustry (pharma, biotech, devices)
- Collaborators
- Institut des Sciences de la Vision, CEISO
- Study start
- 2 Nov 2023 (estimated)
- Primary completion
- 2 Jan 2024 (estimated)
- Study completion
- 2 Jan 2024 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of care arm | Experimental | Device: S360The 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S360In 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. | Device | Standard of care arm |
Primary outcome
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
9 secondary outcomes
Accuracy of the S360's measured data
Time frame: Day 0
Repeatability of the S360's measured data
Time frame: Day 0
Reproducibility of the S360's measured data
Time frame: Day 0
Evaluation of the usefulness of the MDSW S360 in the current practice
Time frame: Day 0
Validation of the technical functionalities of the MDSW S360
Time frame: Day 0
Safety : Adverse events
Time frame: Day 0
Operator's comfort of using the medical device S360
Time frame: Day 0
Comparison of the duration of the two procedure
Time frame: Day 0
Patient satisfaction
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Maleysson principal investigator
Institut des Sciences de la Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S360 in people with Binocular Vision Disorder and Binocular Eye Movement Disorder, run by Sierra Neurovision at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel Moiroud ((+33) 7 82 75 37 79, lionel.moiroud@sierra-neurovision.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (Se) and specificity (Sp) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.