Clinical Investigation for a Multifunction Ophthalmic Measurement Device
Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul-Henri Prevot
- Phone Number: +33 1 72 94 70 09
- Email: prevotph@essilor.fr
Study Locations
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-
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Rennes, France, 35000
- Recruiting
- West Ophta
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Contact:
- FRANCOIS LE GUYADER, Dr
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Contact:
- PIERRE-EMMANUEL ARCADE, Dr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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,
Participants with monophthalmia,
Participants with obvious fixation disorder, strabismus, or nystagmus,
For tonometry measurements: subjects who have: Edematous/ulcerated cornea, following keratoplasty or ocular surgery, following penetrating trauma, severe Keratoconus with risk of hydrops and in case of retinal detachment. Anterior and posterior chamber sulcus IOL, intrastromal rings or lens (type Kamra).
Participants with pupil < 2 mm,
Participants who are with spherical equivalent refraction out of the range -20.00 to + 20.00 D (frontofocometer measurement),
Participants with an astigmatism greater than 8.00 D (<8.00 D) (frontofocometer measurement),
Participants with corneal power out of the range [35-55D],
Participants with axial length out of the range [18-34 mm],
Participants with Intraocular pressure out of [7-50 mm Hg] range,
Participants to a previous phase of this clinical investigation.
Exclusion Criteria (for Healthy children):
Children with neurologic disorders, particularly epileptic or sensory motor troubles,
Children with history of recent ocular surgeries (including refractive surgery less than two weeks)
Children with monophthalmia,
Children with obvious fixation disorder, strabismus, or nystagmus,
Children with pupil < 2 mm
Children with a spherical equivalent refraction out of the range [-20.00 to + 20.00 D] (frontofocometer measurement),
Children with an astigmatism higher than 8.00 D (>8.00 D)
Children with axial length out of the range [18-34 mm]
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Multifonction Ophtalmic Measuring Device
Parameters and images of the anterior and posterior chambers of the human eye
|
Acquisition by the investigational device
Acquisition by the investigational device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relative frequency of successful acquisition for each measurement of the investigational device
Time Frame: One day (measurements are taken during the single visit)
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One day (measurements are taken during the single visit)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: François LE GUYADER, Dr, West Ophta
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WS10339
- 2023-A01481-44 (Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) - France)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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