跳至主要内容
临床试验/NCT04388020
NCT04388020已完成不适用

Effects of Projected Peripheral Defocus on Ocular Biometrics

Kubota Vision Inc.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
1
主要终点
Axial length (AL)

研究概览

简要总结

Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic progression, which is a significant public health concern across the world, especially in Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in order to alter retinal physiology leading to myopia regulation. This study will establish the changes seen during a proof-of-concept that projected defocus in the periphery will stimulate physiological changes similar to those in the literature.

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
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Spherical equivalent +2.00 to -4.00 diopters
  • Refractive cylinder ≤ 0.75 diopters
  • Visual acuity 20/20 -3 or better

排除标准

  • Pregnant or lactating
  • Active ocular infection
  • History of dry eye, strabismus, or amblyopia
  • Previous or planned ocular surgery
  • Use of medication known to affect vision or accommodation

结局指标

主要结局

Axial length (AL)

时间窗: 1 hour

Change in AL from baseline in the test eye vs. control eye

Choroidal thickness (CT)

时间窗: 1 hour

Change in CT from baseline in the test eye vs. control eye

次要结局

未报告次要终点

研究者

发起方
Kubota Vision Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effects of Projected Peripheral Defocus on Ocular... | 临床试验