Clinical Investigation for a Multifunction Ophthalmic Measurement Device

Launched by ESSILOR INTERNATIONAL · Aug 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device that can measure various aspects of eye health and vision. The goal is to see how well this device works for diagnosing and managing conditions like problems with focusing (accommodation disorders), keratoconus (a condition that affects the shape of the cornea), dry eye, and other vision issues. By gathering data from 378 participants, the researchers hope to improve the device's design and usefulness in eye care.

To participate, adults aged 18 and older, as well as healthy children aged 4 to 17, are eligible if they are coming in for a routine eye check-up and are part of a social security scheme. Participants will only need to visit the investigation center once. However, there are some exclusions, such as individuals with certain eye conditions, recent eye surgeries, or those with implanted medical devices. It's important to know that pregnant women and individuals with specific neurological disorders cannot participate. Overall, this trial aims to enhance the tools available for eye care professionals, ultimately benefiting patients' vision health.

Gender

ALL

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,
• • 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 \[18-34 mm\]