跳至主要内容
临床试验/NCT03818880
NCT03818880进行中(未招募)不适用

A Sub-Study to Assess the Choroidal Response to Novel Spectacle Lens to Control Myopia Progression (CHERRY)

SightGlass Vision, Inc.2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
2
主要终点
Choroidal thickness

研究概览

简要总结

Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

详细描述

Diurnal variations in the thickness of the choroid have been reported in the literature , and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site, randomized, controlled, interventional study to confirm the efficacy and safety of spectacle lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral vision. CORE is participating as a clinical site in this three year study which aims to compare changes in ocular length and cycloplegic auto-refraction in children randomised to wear one of either two test or one control spectacle lens designs; the CPRO-1802-001 (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements only at CORE's site by inviting those participants who have already been found eligible for the CPRO-1802-001 study to participate in this parallel study.

研究设计

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

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participating in the CPRO-1802-001 (Cypress_SG) study at CORE
  • Read and signed an Assent and their parent/guardian has signed an information consent letter

排除标准

  • Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)

研究组 & 干预措施

Treatment

Experimental

Subjects wearing novel spectacle lenses will be assessed

干预措施: Novel spectacle lens design (Device)

结局指标

主要结局

Choroidal thickness

时间窗: 3 years

Measurement of choroidal thickness by Triton optical coherence tomographer (OCT), including post-imaging analysis

次要结局

  • Visual field(3 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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