Accommodation DisorderNCT06565091
Clinical Investigation for a Multifunction Ophthalmic Measurement Device
A study testing Measurements of physiological parameters of the anterior chamber and Measurements of the Axial biometry in people with Accommodation Disorder and Keratoconus, run by Essilor International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accommodation Disorder, Keratoconus, Dry Eye
- What is being tested?
- Measurements of physiological parameters of the anterior chamber and Measurements of the Axial biometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to 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.
- 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.
Who cannot join
- 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,
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- 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.
- 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]
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
West Ophta
Rennes, 35000
FRANCOIS LE GUYADER, Dr
PIERRE-EMMANUEL ARCADE, Dr
About this study
Official title: Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
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.
- Conditions
- Accommodation Disorder, Keratoconus, Dry Eye, Refractive Errors, Accommodative Fatigue, Accommodative Inertia
- Being tested
- Measurements of physiological parameters of the anterior chamber, Measurements of the Axial biometry
- Medical subject headings
- Keratoconus, Dry Eye Syndromes, Refractive Errors, Corneal Wavefront Aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurements of physiological parameters of the anterior chamberDevice
Acquisition by the investigational device
Measurements of the Axial biometryDevice
Acquisition by the investigational device
| Study group | Role | What they receive |
|---|---|---|
| Multifonction Ophtalmic Measuring Device | Experimental | Parameters and images of the anterior and posterior chambers of the human eye Receives: Device: Measurements of physiological parameters of the anterior chamber; Device: Measurements of the Axial biometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative frequency of successful acquisition for each measurement of the investigational device
Measured: One day (measurements are taken during the single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start10 Jun 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accommodation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- François LE GUYADER, Dr, Principal investigator, WEST OPHTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565091
- Sponsor's protocol ID
- WS10339
- Other IDs
- 2023-A01481-44
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device
- ClinicalTrials.gov ID
- NCT06565091
- Acronym / sponsor ID
- WS10339
- Conditions
- Accommodation Disorder, Keratoconus, Dry Eye, Refractive Errors, Accommodative Fatigue, Accommodative Inertia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multifonction Ophtalmic Measuring Device | Experimental | Device: Measurements of physiological parameters of the anterior chamber, Device: Measurements of the Axial biometryParameters and images of the anterior and posterior chambers of the human eye |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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"),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurements of physiological parameters of the anterior chamberAcquisition by the investigational device | Device | Multifonction Ophtalmic Measuring Device |
| Measurements of the Axial biometryAcquisition by the investigational device | Device | Multifonction Ophtalmic Measuring Device |
Primary outcome
Relative frequency of successful acquisition for each measurement of the investigational device
Time frame: One day (measurements are taken during the single visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François LE GUYADER, Dr principal investigator
WEST OPHTA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurements of physiological parameters of the anterior chamber and Measurements of the Axial biometry in people with Accommodation Disorder and Keratoconus, run by Essilor International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul-Henri Prevot (+33 1 72 94 70 09, prevotph@essilor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative frequency of successful acquisition for each measurement of the investigational device (time frame: One day (measurements are taken during the single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.