Assessment of Corneal Endothelial Function Following Hypoxic Stress
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to full recovery from swelling
研究概览
简要总结
The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.
详细描述
Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD.
Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in the Fuch's Dystrophy arm of the study must meet following criteria:
- •Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
- •Be scheduled for corneal transplantation in the next 6 months
- •Have no history of prior ocular surgery in study eye
- •Have no history of contact lens intolerance
- •Be motivated and willing to complete ocular imaging tests
- •Subjects in the healthy eyes arm of the study must meet following criteria:
- •Have no prior history of ocular disease including ocular surface disease or glaucoma
- •Have no history of prior ocular surgery in study eye
- •Have no history of contact lens intolerance
- •Be motivated and willing to complete ocular imaging tests
排除标准
- •Pregnant women
结局指标
主要结局
Time to full recovery from swelling
时间窗: three hours
The time it takes for the eye to no longer be swollen
Thickness of the cornea before and after the stress test
时间窗: seven hours
Maximum changes in the thickness of the cornea measured before and after the stress test
The rate of corneal recovery after the stress test
时间窗: three hours
The extent of swelling evident at regular intervals during the 3 hours after the stress test
次要结局
未报告次要终点
研究者
Ula Jurkunas
Associate Professor, Harvard Medical School
Massachusetts Eye and Ear Infirmary