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Official title Clinical Investigation for a Multifunction Ophthalmic Measurement Device
ClinicalTrials.gov ID: NCT06565091
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- Participants able to sit upright in front of the investigational device.
- \ (for Healthy children):
You likely can't join 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 people with forehead or chin injuries which prevent the head from being supported...
- Participants who are deprived of their liberty by judicial or administrative decision and persons hospitalized without their consent (Article L...
- Participants who are subject to a legal protection measure (curatorship, guardianship, safeguard of justice ...) or unable to express their consent...
- 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...
- Participants under exclusion period from another investigation,
See the full eligibility criteria
Who can join
- 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.
- \ (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.
What rules you out
- 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 people 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...
- 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: people 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...
- 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]
The study team makes the final eligibility decision.
Where it's taking place
- Rennes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rennes, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.