Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device

Essilor International1 site in 1 country378 target enrollmentJune 10, 2024

ConditionsAccommodation Disorder Keratoconus Dry Eye Refractive Errors Accommodative Fatigue Accommodative Inertia Aberration, Corneal Wavefront

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Accommodation Disorder
Sponsor: Essilor International
Enrollment: 378
Locations: 1
Primary Endpoint: Relative frequency of successful acquisition for each measurement of the investigational device
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 10, 2024

End Date

August 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Essilor International

Responsible Party

Sponsor

Eligibility Criteria

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 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,