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
Not provided
Not provided
The purpose of this clinical investigation is to check whether the new device can correctly measure a person's degree of myopia and astigmatism.
To evaluate and improve the device's performance, the results (optical correction values and the associated visual acuity) obtained with the investigational device will be compared with the results obtained using standard instruments commonly used by eye care professionals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Myopic Non-Presbyopic Adults | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical correction values obtained with investigational device and visual acuity | Device | Participants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Optical Values | Optical correction values obtained with the investigational device are compared with the values obtained using a phoropter (gold standard method - subjective refraction) | Day One |
| Difference in the proportion of visual acuity levels | Comparison of the proportion of participants reaching specific monocular visual acuity levels (≥10/10 and ≥12/10) when wearing the refraction obtained from the investigational device versus the subjective refraction obtained from a phoropter (gold standard method) | Day One |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Monocular Visual Acuity Distribution | Comparison of the distribution of monocular visual acuity obtained using the refraction from the investigational device versus the objective refraction from an autorefractometer. | Day One |
Not provided
Inclusion Criteria:
Exclusion Criteria:
General criteria for non-inclusion:
The following elements are considered based on the participant's declaration :
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Boutinon, Master of engineering | Contact | +33 6 77 16 43 83 | boutinos@essilor.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gildas Marin, PhD | Essilor International | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essilor International - Ci&T 3 | Créteil | France | 94000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Optical correction values obtained with an autorefractometer and visual acuity | Device | Participants optical correction values are determined using an autorefractometer (objective refraction) and their visual acuity is measured with this optical correction |
|
| Optical correction values obtained with a phoropter and visual acuity | Device | Participants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009799 | Ocular Physiological Phenomena |
Not provided
Not provided