Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00780-47 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the performance of a photorefraction screener in terms of sensibility, sensitivity and accuracy on children aged 3 to 8 y.o. The main objectives of the study are:
Participants after verification of their eligibility and informed consent, participate to a single evaluation visit during which several objective refraction measurements are performed with the investigational device, a tabletop refractometer and a comparable vision screener with and without cyclopegia. Additionally far vision visual acuity, strabismus assessments and subjective refraction measurement are also performed by investigators.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Snapsight photorefraction device | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photorefraction device under investigation | Device | Objective refraction measurement with and without cyclopegia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfomance evaluation for ametropia screening | The performance of the device in terms of sensitivity is evaluated by comparison with a tabletop refractometer. | One day (all measurements are taken during a single evaluation visit). |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of refraction measurements obtained with the device under investigation and a tabletop refractometer | The evaluated refraction measurements are the spherical equivalent and Jackson's cylindrical vectors. | One day (all measurements are taken during a single evaluation visit). |
| Perfomance evaluation for ametropia screening |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Cadoni | Contact | +33 642665760 | cadonis@essilor.fr |
| Name | Affiliation | Role |
|---|---|---|
| Aranaud Sauer, MD, PhD, FEBO | Hôpital Civil de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Krafft private practice | Not yet recruiting | Nancy | France | 54000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Comparator device, Tabletop auto-refractometer | Device | Objective refraction measurement with and without cyclopegia |
|
| Comparator device, portable photorefraction device | Device | Objective refraction measurement with and without cyclopegia |
|
| Distance visual acuity assessments | Other | Distance visual acuity is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia. |
|
| Subjective refraction and far visual acuity | Other | Subjective refraction is assessed and far visual acuity is assessed with the found refraction measures |
|
| Strabismus assessment | Other | Strabismus is assessed with the refraction measures found by the device under investigation and the comparator device with and without cyclopegia. |
|
The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer. |
| One day (all measurements are taken during a single evaluation visit). |
| Perfomance evaluation for amblyopia screening | The performance of the device in terms of sensitivity, specificity, positive and negative predictive values are evaluated by comparison with a tabletop refractometer or the masking test and prism bars for strabismus. | One day (all measurements are taken during a single evaluation visit). |
| Safety assessment and device failures | Type, frequency and severity of adverse events and device failures are evaluated | One day (all measurements are taken during a single evaluation visit). |
| Hôpital civil de Strasbourg | Recruiting | Strasbourg | France | 67091 | France |
|
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided