NCT07335146

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

January 5, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

myopiaeye anatomyophthalmological measurements

Outcome Measures

Primary Outcomes (1)

  • 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

    From enrollment to 3 months after enrollment

Study Arms (1)

MRI and ophthalmological measurements

EXPERIMENTAL

All enrolled participants will undergo the same eye examinations such as head MRI and ophthalmological measurements

Device: Ophtalmic measurements to estimate geometrical distancesDevice: MRIDevice: Ophtalmic measurements to measure wavefront aberrations

Interventions

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.

MRI and ophthalmological measurements
MRIDEVICE

Participants will undergo Magnetic Resonance Imaging (MRI) to image their eyes. A head antenna will be used. All measurements are non-invasive.

MRI and ophthalmological measurements

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.

MRI and ophthalmological measurements

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Spherical equivalent under cycloplegia greater -6.5 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)

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

HyperopiaMyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Julien Savatosky, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because participant consent did not include permission for data sharing.

Locations