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临床试验/NCT06771258
NCT06771258尚未招募不适用

What Effect Does Looking At Red Light Have on the Eye in Children and Young People? - a Proof-of-concept Study

University College, London1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Axial length

研究概览

简要总结

In this project the research team will begin to find out whether shining a red LED light at the eyes can slow down the worsening of short-sightedness in children.

This is important, because short-sightedness now starts at a younger age and worsens faster than in the past. Many people are at risk of permanently losing their eyesight in middle-age because of short-sightedness.

The researchers plan to use red LED light, which is safe to use. Red-light treatment improves the blood flow at the back of the eye, in a layer called "choroid", which can be measured on eye-scans. The team have done a study with healthy adults, which showed that red-light is safe and gently improves the blood flow at the back of the eye. In adults, this has no effect on myopia, because their eyes are fully grown. In children, red-light may slow down myopia, and in this project, the researchers want to find out which level of red-light is needed to have this effect. The researchers will ask 24 children age 5-12 years to use red-light for three minutes twice a day for three months. Three will be 4 groups of children, and each group will use a different level of brightness. The researchers will measure the eye length and the thickness of the choroid at the start and 1 and 3 months later and compare the change in eye length between the different groups.

In practice, children will need to use the treatment for several years. The researchers will use the results of this study to prepare a longer study with more children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •short-sightedness between -1.00D and -6.00 diopters in both eyes
  • •best-corrected visual acuity 0.1 logMAR or better in both eyes

排除标准

  • •underlying condition/syndrome causing myopia
  • •previous or current myopia-modifying treatment
  • •abnormal ocular refractive anatomy or previous intraocular or ocular surgery

研究组 & 干预措施

Intensity 1

Active Comparator

Children will use red-light of the lowest intensity, twice daily for 3 minutes, at home

干预措施: Red Light (PDT) (Other)

Intensity 2

Active Comparator

Children will use red-light of low intensity, but slightly higher than in the Intensity 1 arm, twice daily for 3 minutes, at home

干预措施: Red Light (PDT) (Other)

Intensity 3

Active Comparator

Children will use red-light of medium intensity, slightly higher than in the Intensity 2 arm, twice daily for 3 minutes, at home

干预措施: Red Light (PDT) (Other)

Intensity 4

Active Comparator

Children will use red-light of medium intensity, slightly higher than in the Intensity 3 arm, twice daily for 3 minutes, at home

干预措施: Red Light (PDT) (Other)

结局指标

主要结局

Axial length

时间窗: 3 months

The researchers will measure the length of the eyeballs using an optical biometer; these are the most sensitive outcome measure in myopia studies, and the least invasive measurement method.

次要结局

  • Spherical equivalent(3 months)
  • Subfoveal choroidal thickness(3 months)
  • Colour contrast sensitivity(3 months)
  • Visual acuity(3 months)
  • Tolerability/usability(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Red Light Childhood Myopia Proof-of-concept | 临床试验