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Clinical Investigation for a Multifunction Ophthalmic Measurement Device | Clinical Trials | Clareo Health

RECRUITINGNA

Clinical Investigation for a Multifunction Ophthalmic Measurement Device

Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device

NCT06565091•Essilor International

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.

Detailed Description

The objectives of this clinical investigation are: * Develop the device in clinical conditions (refine the intensity and gain of the light sources and the acquisition time of the cameras and photodiodes, in order to cover the targeted population). * Evaluate the safety and clinical performance and/or effectiveness of the medical device and determine whether the system is suitable for the purposes and populations for which it is intended.

Eligibility

Age

4 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
•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 to express their consent (Article L1121-8 of "Code de Santé Publique"),
•Participants who are not 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 under exclusion period from another investigation,
•Women who are pregnant or breastfeeding women; (Article L1121-5 of "Code de Santé Publique"). No additional risk had been identified for pregnant woman in participating in the investigation. Nevertheless, pregnancy induces ocular changes: in case of AE, the causality with the device or with pregnancy may be difficult to establish, justifying the non-inclusion of this population.
•Participants with neurologic disorder, particularly epileptic or sensory motor troubles,
•Participants with history of recent ocular surgeries (including refractive surgery less than 2 weeks),
•Participants who are ESSILOR International/ESSILOR Luxottica employees,
+18 more criteria

Locations (1)

West Ophta

Rennes, France

Key Dates

Start Date

June 10, 2024

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2025

Last Updated

August 21, 2024

Enrollment

378

ESTIMATED participants

Conditions

Accommodation DisorderKeratoconusDry EyeRefractive ErrorsAccommodative FatigueAccommodative InertiaAberration, Corneal Wavefront

Interventions

Measurements of physiological parameters of the anterior chamber

DEVICE

Measurements of the Axial biometry

DEVICE

Contacts

Paul-Henri Prevot

CONTACT

+33 1 72 94 70 09 prevotph@essilor.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Investigation for a Multifunction Ophthalmic Measurement Device

Inclusion Criteria

Exclusion Criteria

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