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临床试验/NCT05943912
NCT05943912进行中(未招募)不适用

Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults

Czech Technical University in Prague1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
Axial length of eye

研究概览

简要总结

The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.

详细描述

The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes).

Defocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15.

The majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes.

The goals of our study:

  • compare the efficacy of DIMS spectacle lenses with SV spectacle lenses at slowing the progression of myopia in the category of Czech children and young adults (effect on axial length and refractive changes)
  • monitoring axial length and refractive changes in myopic children and young adults (aged 6-26)
  • monitoring adaptation to DIMS lenses in myopes aged 6-26 years monitoring the influence of the environment and individual behavior on the progression of myopia

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Progressive myopia
  • Myopes aged 6-26 years
  • Myopia between -0,25D and -8,5D
  • Astigmatism -0,25 and -2,25DC

排除标准

  • Ocular pathology
  • Amblyopia
  • Non-compliance to eye examinations

结局指标

主要结局

Axial length of eye

时间窗: in 36 moths therapy

biometry (Lenstar 900)

次要结局

  • Objective refraction(in 36 month therapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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