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临床试验/NCT05030103
NCT05030103尚未招募不适用

An Open, Prospective Clinical Trial on the Use of Reading Glasses in Children to Prevent Myopia

Reis Augenklinik AG2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,500
试验地点
2
主要终点
Development of myopia

研究概览

简要总结

The last decades have seen a significant increase in myopia in children and young adults. Possible cause: increased near-work (school, computer, smartphone). Rationale: Reading glasses support the accommodative effort of the eyes. By wearing reading glasses, there is less interference with the young eye´s physiological axial growth despite increased near-work. Main objective: does the use of reading glasses during near-work in children and adolescents reduce the incidence of myopia.

详细描述

In myopia (nearsightedness), the eyeball is relatively to long, which means that the image produced by the cornea and lens is displayed in front of the retina.

The axial length of an adult eye is on average around 23 millimeters. Every millimeter of additional length must be corrected with a -2.75 diopter lens.

In newborns, the eyeball is about 18 millimeters long. It is believed that there are feedback loops during childhood and adolescence to control the growth of the eye.

Epidemiological studies show that myopia is an increasing health problem. There is a growing body of epidemiological evidence that environmental factors can influence the development of myopia.

The link between the environment and myopia lies in the quality of the retinal image. Experimental studies in various species have shown that if the retinal image is missing, eye growth is disturbed. Of even greater importance for the development of myopia is the knowledge that the primate eye can change its growth, depending on the strength and type of blurring of the retinal image: if lenses are placed in front of the eye during development, the eye growth changes in such a way that a sharp retinal image is achieved through these lenses. If divergent lenses are placed in front of the eye, the eye becomes longer, and if convergent lenses are placed in front of it, it becomes correspondingly shorter.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
6 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children of both sexes from the age of 6
  • Children whose parents have read and signed the declaration of consent
  • Spherical equivalent of refraction <-0.5 dpt.
  • Distant vision in both eyes without correction 1.0
  • Willingness to wear reading glasses
  • Possibility of a five-year follow-up

排除标准

  • Children who already wear glasses
  • Astigmatism over 1.5 diopters
  • Anisometropy greater than 1.5 diopters
  • Eye diseases that affect refraction development

结局指标

主要结局

Development of myopia

时间窗: Five years

Number of participants which develop myopia within the follow-up period of five years

次要结局

未报告次要终点

研究者

发起方
Reis Augenklinik AG
申办方类型
Other
责任方
Sponsor

研究点 (2)

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