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临床试验/NCT07335146
NCT07335146招募中不适用

Modélisation de l'œil Myope Infantile Par IRM et OCT

Essilor International2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月18日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Eye anatomy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

MRI and ophthalmological measurements

Experimental

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

干预措施: Ophtalmic measurements to estimate geometrical distances (Device)

MRI and ophthalmological measurements

Experimental

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

干预措施: MRI (Device)

MRI and ophthalmological measurements

Experimental

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

干预措施: Ophtalmic measurements to measure wavefront aberrations (Device)

结局指标

主要结局

Eye anatomy

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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