Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorEssilor International

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 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

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Healthy Myopic Non-Presbyopic AdultsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Day One
2

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)

Time frame
Day One

Secondary outcomes

1

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.

Time frame
Day One

Other outcomes

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: