About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Volunteers, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
Aged between 18 and 39 years at the time of study inclusion
Wear corrective glasses
With an ophthalmologist's prescription for corrective eyewear less than 3 years old
Disqualifiers
Essilor International employee
Pregnant, or breast-feeding women (Article L1121-5)
Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research
Adults incapable or unable to express consent (Article L1121-8)
Trial design
Single group
Treatments tested in this trial
Optical correction values obtained with investigational device and visual acuity
DeviceParticipants optical correction values are determined using the investigational device and their visual acuity is measured with this optical correction
Optical correction values obtained with an autorefractometer and visual acuity
DeviceParticipants 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
DeviceParticipants optical correction values are determined using a phoropter (subjective refraction) and their visual acuity is measured with this optical correction
Treatment groups
Trial outcomes
Primary outcomes
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)
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)
Secondary outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: