Effects of Projected Peripheral Defocus on Ocular Biometrics
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
- 是
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
