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 range
18 Years – 39 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of Optical Values
Timeframe: Day One
2
Difference in the proportion of visual acuity levels