Evaluation of a multifunctional ophthalmic measurement device

Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device

This study is testing a new eye measurement device to see if it works well and is safe for measuring different eye conditions in people.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 378 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: Essilor International (Industry-sponsored)
• Locations: 1 site (Rennes)
• Trial ID: NCT06565091 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to assess the clinical utility of a multifunctional measuring device designed for ophthalmology. The study will involve 378 participants, each attending a single visit at the investigation center. The objectives include refining the device's design and evaluating its safety and effectiveness in measuring various physiological parameters of the anterior chamber. The results will help determine the device's suitability for the intended populations and purposes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older, as well as healthy children aged 4 to 17, who are attending routine consultations.

Not a fit: Patients with implanted electronic medical devices may not benefit from this study due to safety concerns.

Why it matters

Potential benefit: If successful, this device could enhance the diagnosis and management of various eye conditions, improving patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving ophthalmic measurement techniques.

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 \[18-34 mm\]

Where this trial is running

Rennes

• West Ophta — Rennes, France (Recruiting)

Study contacts

• Principal investigator: François LE GUYADER, Dr — West Ophta
• Study coordinator: Paul-Henri Prevot

Conditions Accommodation Disorder; Keratoconus; Dry Eye; Refractive Errors; Accommodative Fatigue; Accommodative Inertia; Aberration, Corneal Wavefront