Clinical Investigation for a Multifunction Ophthalmic Measurement Device

NCT06565091 | Recruiting

• 2 other identifiers: WS103392023-A01481-44
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Relative frequency of successful acquisition for each measurement of the investigational device

  One day (measurements are taken during the single visit)

Study Arms (1)

Multifonction Ophtalmic Measuring Device

EXPERIMENTAL

Parameters and images of the anterior and posterior chambers of the human eye

Device: Measurements of physiological parameters of the anterior chamber; Device: Measurements of the Axial biometry

Interventions

Measurements of physiological parameters of the anterior chamber DEVICE

Acquisition by the investigational device

Multifonction Ophtalmic Measuring Device

Measurements of the Axial biometry DEVICE

Acquisition by the investigational device

Multifonction Ophtalmic Measuring Device

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 \[35-55D\],

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

West Ophta

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Keratoconus; Dry Eye Syndromes; Refractive Errors; Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• François LE GUYADER, Dr

  WEST OPHTA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul-Henri Prevot

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: June 10, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

FR (1)