跳至主要内容
临床试验/NCT06636019
NCT06636019Enrolling By Invitation不适用

Change in Choroidal Thickness of Myopic Eyes With a Myopia Control Contact Lens

University Hospital Augsburg1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
1
主要终点
Choroidal thickness

研究概览

简要总结

In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness.

详细描述

The increasing incidence of short-sightedness (myopia) worldwide has led to the development of various therapies to control axial length myopia. The latest developments include contact lenses to inhibit the growth of the bulb length, which should influence the growth of the eye in childhood and adolescence by inducing a myopic defocus in the periphery of the retina.

In this study, the direct effect of the MiSight contact lens (Cooper Vision), a daily disposable contact lens recently approved in Germany for the treatment of myopia, will be investigated. The aim of this study is to demonstrate an increase in choroidal thickness due to the myopic defocus induced by the contact lens. The increase in choroidal thickness after 30 minutes of exposure to the myopic defocus induced by the contact lens will be demonstrated by measuring the subfoveal and macular choroidal thickness. In addition, the influence of accommodation will be investigated by measuring the choroidal thickness after 30 minutes of activity at near and far distance. One eye of each of 8 healthy subjects with myopic refraction from -0.5 diopters in the spherical equivalent will be included, with laterality (right/left) being randomized. The choroidal thickness is measured using optical coherence tomography (OCT), which is standard in clinical routine. The examination is non-invasive and is carried out at three points in time: The baseline measurement is carried out before inserting the contact lens, then after 30 minutes of exposure and near focusing. A further measurement is carried out within a week after a further 30 minutes of exposure and distance focusing, so that the results are not distorted by the previous near work. In addition, the axial length is determined at each of the 3 measurement times using optical biometry.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • myopic refraction
  • consent to participate
  • minimum age 18 years
  • full legal capacity

排除标准

  • ocular disease affecting imaging quality including but not limited to cataract, keratoconus
  • ocular disease affecting choroidal thickness (pachychoroidal disease)
  • astigmatism greater than 1,5 diopters
  • best corrected distance visual acuity of 0,1 logMAR or worse
  • status post eye surgery
  • status post treatment for myopia control

结局指标

主要结局

Choroidal thickness

时间窗: 30 minutes

Choroidal thickness is measured after contact lens wear.

次要结局

未报告次要终点

研究者

发起方
University Hospital Augsburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. med.Isabella Baur

Principal Investigator

University Hospital Augsburg

研究点 (1)

Loading locations...

相似试验