Clinical Investigation for a Multifunction Ophthalmic Measurement Device (NCT06565091) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
France378 participantsStarted 2024-06-10
Plain-language summary
The purpose of this clinical investigation is to evaluate the clinical utility of a multifunctional measuring device for Ophtalmology.
The results of this clinical investigation will be used to refine and validate the device design.
378 participants total will be included in the trial, each having only one visit at the investigation center.
Who can participate
Age range
4 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:
Adults ≥ 18 years old and Healthy children\* ≥ 4 years and \<18 of age.
Participants initially coming to the center for a routine consultation
Participants who are affiliated to a social security scheme or beneficiaries of such a scheme (L. 1121-8-1 of the Public Health Code of "Code de Santé Publique"),
Participants able to sit upright in front of the investigational device.
Inclusion Criteria\* (for Healthy children):
Healthy children ≥ 4 years and \<18 of age. The parents must have consented to their child's participation.
Children who are affiliated to parent's social security scheme or beneficiaries of such a scheme (L. 1121-8-1 of the Public Health Code of "Code de Santé Publique")
Children initially coming to the center for a routine consultation
Children able to sit upright in front of the instrument.
Exclusion Criteria:
Participants with implanted electronic medical device such as pacemaker, insulin pump, cochlear implant, electrostimulator or hearing aid,
Participants not able to sit upright in front of the instrument or subjects with forehead or chin injuries which prevent the head from being supported on the forehead / chin rest.
Participants who are deprived of their liberty by judicial or administrative decision and persons hospitalized without their consent (Article L. 1121-6 of "Code de Santé Publique"),
Participants who are subject to a legal protection measure (curatorship, guardianship, safeguard of justice ...) or unable t…
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
Relative frequency of successful acquisition for each measurement of the investigational device
Timeframe: One day (measurements are taken during the single visit)