ClinicalTrials.gg
RecruitingNCT06565091Updated Aug 21, 2024

Clinical Investigation for a Multifunction Ophthalmic Measurement Device

An interventional study of Measurements of physiological parameters of the anterior chamber and Measurements of the Axial biometry in Accommodation Disorder, Keratoconus and Dry Eye, sponsored by Essilor International. Recruiting at 1 site in France. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Essilor International · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
378
Allocation
Not applicable
Ages
4 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Accommodation Disorder
  • Keratoconus
  • Dry Eye
  • Refractive Errors
  • Accommodative Fatigue
  • Accommodative Inertia
  • Aberration, Corneal Wavefront
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 378 is above the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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]

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
378 participants (estimated)

Study arms

  • Experimental
    Multifonction Ophtalmic Measuring Device

    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

  • DeviceMeasurements of physiological parameters of the anterior chamber

    Acquisition by the investigational device

  • DeviceMeasurements of the Axial biometry

    Acquisition by the investigational device

06

What researchers measure

Primary outcomes

  1. Relative frequency of successful acquisition for each measurement of the investigational device

    Time frame: One day (measurements are taken during the single visit)

07

Study locations

1 of 1 sites recruiting
  • West Ophta
    Rennes, 35000, France
    Recruiting
    • FRANCOIS LE GUYADER, Dr · Contact
    • PIERRE-EMMANUEL ARCADE, Dr · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Aug 2025, 14 months after the start.

Of 68 interventional studies with no phase under Keratoconus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2024
First posted
Aug 21, 2024
StartActual
Jun 10, 2024
Primary completionEst.
Aug 2025
CompletionEst.
Aug 2025
Last update
Aug 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06565091
Responsible party
Sponsor
First posted
Aug 21, 2024
Start date
Jun 10, 2024
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Aug 21, 2024

Study contacts

Paul-Henri Prevot
Contact
prevotph@essilor.fr
+33 1 72 94 70 09
François LE GUYADER, Dr
principal investigator · WEST OPHTA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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