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Eye Imaging for the Study of Childhood Myopia (SELENA)

E

Essilor

Status

Not yet enrolling

Conditions

Hyperopia and Myopia

Treatments

Device: Ophtalmic measurements to measure wavefront aberrations
Device: MRI
Device: Ophtalmic measurements to estimate geometrical distances

Study type

Interventional

Funder types

Industry

Identifiers

NCT07335146
WS10445
2025-A00844-45 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

MRI and ophthalmological measurements
Experimental group
Description:
All enrolled participants will undergo the same eye examinations such as head MRI and ophthalmological measurements
Treatment:
Device: Ophtalmic measurements to estimate geometrical distances
Device: Ophtalmic measurements to measure wavefront aberrations
Device: MRI

Trial contacts and locations

1

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Central trial contact

Julien Savatosky, Doctor

Data sourced from clinicaltrials.gov

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