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临床试验/NCT04415684
NCT04415684
已完成
不适用

Effects of Projected Peripheral Defocus on Ocular Biometrics Using a Wearable Device

Kubota Vision Inc.1 个研究点 分布在 1 个国家目标入组 26 人2020年6月29日
适应症Myopia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Myopia
发起方
Kubota Vision Inc.
入组人数
26
试验地点
1
主要终点
Choroidal thickness (CT)
状态
已完成
最后更新
4年前

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 utilizing a wearable device will stimulate physiological changes similar to those in the literature.

注册库
clinicaltrials.gov
开始日期
2020年6月29日
结束日期
2020年8月20日
最后更新
4年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Kubota Vision Inc.
责任方
Sponsor

入排标准

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

Choroidal thickness (CT)

时间窗: 1 hour

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

Axial length (AL)

时间窗: 1 hour

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

研究点 (1)

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