Eye Imaging for the Study of Childhood Myopia

Official title

Modélisation de l'œil Myope Infantile Par IRM et OCT

Overview

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.

Interventions

• Device Ophtalmic measurements to estimate geometrical distances
  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.
• Device MRI
  Participants will undergo Magnetic Resonance Imaging (MRI) to image their eyes. A head antenna will be used. All measurements are non-invasive.
• Device Ophtalmic measurements to measure wavefront aberrations
  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.

Primary outcome measures

• Eye anatomy [Time frame: From enrollment to 3 months after enrollment]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 1 center

• Hôpital Fondation Adolphe de Rothschild — Paris

Identifiers

NCT: NCT07335146 · WS10445 · 2025-A00844-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗