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
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.
The objectives of this clinical investigation are:
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 →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.
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]
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Acquisition by the investigational device
Acquisition by the investigational device
Relative frequency of successful acquisition for each measurement of the investigational device
Time frame: One day (measurements are taken during the single visit)
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.
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