Hyperopia and MyopiaSELENANCT07335146
Eye Imaging for the Study of Childhood Myopia
A study testing Ophtalmic measurements to estimate geometrical distances, MRI and Ophtalmic measurements to measure wavefront aberrations in people with Hyperopia and Myopia, run by Essilor International at 1 site in France.
Trial summary
Myopia (nearsightedness) is increasing worldwide and is becoming a serious public health problem. Studies estimate that by 2050, if no action is taken, almost half of the world's population will be myopic. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperopia and Myopia
- What is being tested?
- Ophtalmic measurements to estimate geometrical distances, MRI and Ophtalmic measurements to measure wavefront aberrations
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Spherical equivalent under cycloplegia greater -9.75 D and less than 2 D
- Beneficiary of social security
- Written consent from both holders of parental authority (or from one in case of exclusive parental authority)
Who cannot join
- Declared neurological deficit, including history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (for example, balance disorders)
- Current or progressive pathology of the eyes or their appendages that may affect vision, other than myopia (examples: glaucoma, retinitis pigmentosa…)
- Declared aphakia or pseudophakia (intraocular implant)
- Ocular motility problem such as strabismus or nystagmus
- Contraindication to MRI (claustrophobia, implanted devices such as pacemaker, etc.)
- Wearing fixed orthodontic appliances that affect the quality of orbital MRI scans
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Julien Savatovsky, Doctor, 00331 48 03 69 30, jsavatovsky@for.paris
About this study
Official title: Modélisation de l'œil Myope Infantile Par IRM et OCT
Myopia (nearsightedness) is increasing worldwide and is becoming a serious public health problem. Studies estimate that by 2050, if no action is taken, almost half of the world's population will be myopic. About 10% of people could develop severe myopia, which increases the risk of serious eye problems such as retinal detachment, damage to the macula, or glaucoma.
Children are particularly affected because myopia often worsens as they grow. Several treatments are now available to slow the progression of myopia in children, but these treatments are not equally effective for everyone. Some children respond better than others, and the reasons for these differences are not yet well understood. One possible explanation is that differences in eye anatomy may influence the effectiveness of a treatment. This suggests that myopia treatments may need to be tailored to each child. By studying the anatomy of the eye, researchers could improve and personalize myopia control strategies.
The study entitled "Eye imaging for the study of childhood myopia" aims to better understand the structure of children's eyes. The study will collect clinical data, including images of the eye taken with MRI and measurements of the eye obtained using standard eye examination devices. The data will then be analyzed using image-processing and statistical methods to allow a detailed study of children's eye anatomy.
- Conditions
- Hyperopia and Myopia
- Being tested
- Ophtalmic measurements to estimate geometrical distances, MRI, Ophtalmic measurements to measure wavefront aberrations
- Keywords
- myopia, eye anatomy, ophthalmological measurements
- Medical subject headings
- Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophtalmic measurements to estimate geometrical distancesDevice
Patients will undergo routine ophthalmic examinations, such as ocular biometry to estimate axial length and corneal topography. Anatomical characteristics will then be derived from the geometric measurements obtained from each device. All measurements are non-invasive and non-ionizing. They all involve conventional ophthalmic devices that are widely used in clinical settings.
MRIDevice
Participants will undergo Magnetic Resonance Imaging (MRI) to image their eyes. A head antenna will be used. All measurements are non-invasive.
Ophtalmic measurements to measure wavefront aberrationsDevice
Patients will undergo ophthalmic measurements to assess ocular wavefront aberrations. These measurements will be performed using commercially available devices that are widely accepted in routine clinical practice. All procedures are non-invasive and non-ionizing.
| Study group | Role | What they receive |
|---|---|---|
| MRI and ophthalmological measurements | Experimental | All enrolled participants will undergo the same eye examinations such as head MRI and ophthalmological measurements Receives: Device: Ophtalmic measurements to estimate geometrical distances; Device: MRI; Device: Ophtalmic measurements to measure wavefront aberrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye anatomy
This set of data will enable an in-depth study of the eye anatomy: MRI will provide anatomical characteristics of the eyeball and its surrounding tissues such as the optical nerve. Ophtalmic measurements will provide anatomical characteristics of the eye's refractive system, such as corneal pachymetry, with optimal geometric resolution. Thus, MRI images and ophtalmic measurements will be combined to study the overall eye anatomy.
Period: From inclusion up to 3 months after inclusion
Measured: From enrollment to 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start18 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperopia and MyopiaStudies of the same condition, open and under way.
- More trials run by Essilor InternationalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335146
- Sponsor's protocol ID
- WS10445
- Other IDs
- 2025-A00844-45
- Acronym
- SELENA
- Status last verified
- Mar 2026
- First submitted
- 5 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because participant consent did not include permission for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modélisation de l'œil Myope Infantile Par IRM et OCT
- ClinicalTrials.gov ID
- NCT07335146
- Acronym / sponsor ID
- SELENA / WS10445
- Conditions
- Hyperopia and Myopia
- Keywords
- myopia, eye anatomy, ophthalmological measurements
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (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.
Myopia (nearsightedness) is increasing worldwide and is becoming a serious public health problem. Studies estimate that by 2050, if no action is taken, almost half of the world's population will be myopic. About 10% of people could develop severe myopia, which increases the risk of serious eye problems such as retinal detachment, damage to the macula, or glaucoma.
Children are particularly affected because myopia often worsens as they grow. Several treatments are now available to slow the progression of myopia in children, but these treatments are not equally effective for everyone. Some children respond better than others, and the reasons for these differences are not yet well understood. One possible explanation is that differences in eye anatomy may influence the effectiveness of a treatment. This suggests that myopia treatments may need to be tailored to each child. By studying the anatomy of the eye, researchers could improve and personalize myopia control strategies.
The study entitled "Eye imaging for the study of childhood myopia" aims to better understand the structure of children's eyes. The study will collect clinical data, including images of the eye taken with MRI and measurements of the eye obtained using standard eye examination devices. The data will then be analyzed using image-processing and statistical methods to allow a detailed study of children's eye anatomy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI and ophthalmological measurements | Experimental | Device: Ophtalmic measurements to estimate geometrical distances, Device: MRI, Device: Ophtalmic measurements to measure wavefront aberrationsAll enrolled participants will undergo the same eye examinations such as head MRI and ophthalmological measurements |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Spherical equivalent under cycloplegia greater -9.75 D and less than 2 D
- Beneficiary of social security
- Written consent from both holders of parental authority (or from one in case of exclusive parental authority)
Key exclusion criteria (6 listed)
- Declared neurological deficit, including history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (for example, balance disorders)
- Current or progressive pathology of the eyes or their appendages that may affect vision, other than myopia (examples: glaucoma, retinitis pigmentosa…)
- Declared aphakia or pseudophakia (intraocular implant)
- Ocular motility problem such as strabismus or nystagmus
- Contraindication to MRI (claustrophobia, implanted devices such as pacemaker, etc.)
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 |
|---|---|---|
| Ophtalmic measurements to estimate geometrical distancesPatients will undergo routine ophthalmic examinations, such as ocular biometry to estimate axial length and corneal topography. Anatomical characteristics will then be derived from the geometric measurements obtained from each device. All measurements are non-invasive and non-ionizing. They all involve conventional ophthalmic devices that are widely used in clinical settings. | Device | MRI and ophthalmological measurements |
| MRIParticipants will undergo Magnetic Resonance Imaging (MRI) to image their eyes. A head antenna will be used. All measurements are non-invasive. | Device | MRI and ophthalmological measurements |
| Ophtalmic measurements to measure wavefront aberrationsPatients will undergo ophthalmic measurements to assess ocular wavefront aberrations. These measurements will be performed using commercially available devices that are widely accepted in routine clinical practice. All procedures are non-invasive and non-ionizing. | Device | MRI and ophthalmological measurements |
Primary outcome
Eye anatomy
Time frame: From enrollment to 3 months after enrollment
This set of data will enable an in-depth study of the eye anatomy: MRI will provide anatomical characteristics of the eyeball and its surrounding tissues such as the optical nerve. Ophtalmic measurements will provide anatomical characteristics of the eye's refractive system, such as corneal pachymetry, with optimal geometric resolution. Thus, MRI images and ophtalmic measurements will be combined to study the overall eye anatomy. Period: From inclusion up to 3 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent did not include permission for data sharing.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophtalmic measurements to estimate geometrical distances, MRI and Ophtalmic measurements to measure wavefront aberrations in people with Hyperopia and Myopia, 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien Savatosky, Doctor (00331 48 03 69 30, jsavatovsky@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eye anatomy (time frame: From enrollment to 3 months after enrollment). 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 16 Sep 2026.