Studies
| Study First Submitted Date | 2022-08-23 |
| Study First Posted Date | 2022-08-31 |
| Last Update Posted Date | 2023-04-19 |
| Start Month Year | November 2, 2023 |
| Primary Completion Month Year | January 2, 2024 |
| Verification Month Year | August 2022 |
| Verification Date | 2022-08-31 |
| Last Update Posted Date | 2023-04-19 |
Detailed Descriptions
| Sequence: | 20803227 |
| 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). |
Facilities
| Sequence: | 200795670 |
| Name | Institut des Sciences de la Vision |
| City | Saint-Étienne |
| Zip | 42100 |
| Country | France |
Facility Contacts
| Sequence: | 28220702 |
| Facility Id | 200795670 |
| Contact Type | primary |
| Name | Sandra Maleysson |
Conditions
| Sequence: | 52379123 | Sequence: | 52379124 | Sequence: | 52379125 |
| Name | Binocular Vision Disorder | Name | Binocular Eye Movement Disorder | Name | Ocular Motion; Disorder |
| Downcase Name | binocular vision disorder | Downcase Name | binocular eye movement disorder | Downcase Name | ocular motion; disorder |
Id Information
| Sequence: | 40306788 |
| Id Source | org_study_id |
| Id Value | S360 IC-01 |
Countries
| Sequence: | 42729393 |
| Name | France |
| Removed | False |
Design Groups
| Sequence: | 55824502 |
| Group Type | Experimental |
| Title | Standard of care arm |
| Description | 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. |
Interventions
| Sequence: | 52689315 |
| Intervention Type | Device |
| Name | S360 |
| Description | 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. |
Keywords
| Sequence: | 80152639 | Sequence: | 80152640 | Sequence: | 80152641 | Sequence: | 80152642 |
| Name | Eye tracker | Name | Orthoptics analysis | Name | Neuro-visuo-motor analysis | Name | Eye movement |
| Downcase Name | eye tracker | Downcase Name | orthoptics analysis | Downcase Name | neuro-visuo-motor analysis | Downcase Name | eye movement |
Design Outcomes
| Sequence: | 178147100 | Sequence: | 178147101 | Sequence: | 178147102 | Sequence: | 178147103 | Sequence: | 178147104 | Sequence: | 178147105 | Sequence: | 178147106 | Sequence: | 178147107 | Sequence: | 178147108 | Sequence: | 178147109 |
| Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Sensitivity (Se) and specificity (Sp) | Measure | Accuracy of the S360's measured data | Measure | Repeatability of the S360's measured data | Measure | Reproducibility of the S360's measured data | Measure | Evaluation of the usefulness of the MDSW S360 in the current practice | Measure | Validation of the technical functionalities of the MDSW S360 | Measure | Safety : Adverse events | Measure | Operator's comfort of using the medical device S360 | Measure | Comparison of the duration of the two procedure | Measure | Patient satisfaction |
| Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 | Time Frame | Day 0 |
| Description | Sensitivity (Se) and specificity (Sp) of performed diagnosis using recorded data from the S360 versus performed diagnosis with standard measurement | Description | Error rate calculation of the S360's measured data | Description | Coefficient of variation calculation of the S360's measured data | Description | The reproducibility coefficient of the S360's measured data | Description | Rate of positive feedback estimation | Description | 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 | Description | Incidence of the medical device's related-adverse events estimation | Description | 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 | Description | Average duration of the two procedures (S360 vs Standard of care) | Description | 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 |
Browse Conditions
| Sequence: | 194277510 | Sequence: | 194277511 | Sequence: | 194277512 | Sequence: | 194277513 | Sequence: | 194277514 | Sequence: | 194277515 | Sequence: | 194277516 | Sequence: | 194277517 | Sequence: | 194277518 | Sequence: | 194277519 |
| Mesh Term | Movement Disorders | Mesh Term | Vision Disorders | Mesh Term | Ocular Motility Disorders | Mesh Term | Strabismus | Mesh Term | Central Nervous System Diseases | Mesh Term | Nervous System Diseases | Mesh Term | Sensation Disorders | Mesh Term | Neurologic Manifestations | Mesh Term | Eye Diseases | Mesh Term | Cranial Nerve Diseases |
| Downcase Mesh Term | movement disorders | Downcase Mesh Term | vision disorders | Downcase Mesh Term | ocular motility disorders | Downcase Mesh Term | strabismus | Downcase Mesh Term | central nervous system diseases | Downcase Mesh Term | nervous system diseases | Downcase Mesh Term | sensation disorders | Downcase Mesh Term | neurologic manifestations | Downcase Mesh Term | eye diseases | Downcase Mesh Term | cranial nerve diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48513336 | Sequence: | 48513337 | Sequence: | 48513338 |
| Agency Class | INDUSTRY | Agency Class | UNKNOWN | Agency Class | INDUSTRY |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | Sierra Neurovision | Name | Institut des Sciences de la Vision | Name | CEISO |
Overall Officials
| Sequence: | 29394638 |
| Role | Principal Investigator |
| Name | Sandra Maleysson |
| Affiliation | Institut des Sciences de la Vision |
Central Contacts
| Sequence: | 12062041 |
| Contact Type | primary |
| Name | Lionel Moiroud |
| Phone | (+33) 7 82 75 37 79 |
| lionel.moiroud@sierra-neurovision.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68431685 |
| Design Group Id | 55824502 |
| Intervention Id | 52689315 |
Eligibilities
| Sequence: | 30885636 |
| Gender | All |
| Minimum Age | 6 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| 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. |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254117240 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 6 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 9 |
Designs
| Sequence: | 30631398 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28997979 |
| Responsible Party Type | Sponsor |