Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopi… (NCT07297810) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of a New Device and Method to Assess the Degree of Myopia and/or Astigmatism in Myopic People
France30 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 39 Years
SexALL
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Inclusion Criteria:
* 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
* Spherical error of each meridian within the range of \[-5.00 ; -0.50 D\]
* Cylindrical defect included in interval \[-4.50 ; 0.00 D\]
* Corrected monocular visual acuity ≤ 0.0 logMAR for distance vision (≥10/10)
* French Social Security beneficiary
Exclusion Criteria:
General criteria for non-inclusion:
* 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)
* Participant included in another ongoing study or in a period of exclusion
* All categories of persons particularly protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the French Public Health Code)
* Amblyopia, strabismus, nystagmus
* Wearing progressive lenses
The following elements are considered based on the participant's declaration :
* De…
What they're measuring
1
Difference of Optical Values
Timeframe: Day One
2
Difference in the proportion of visual acuity levels