Effect of TrueTear Use on Anterior Corneal Surface Imaging Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Surface Asymmetry Index (SAI) Assessed With Corneal Topography
研究概览
简要总结
This study will evaluate the utility of TrueTear™ to improve anterior corneal surface imaging quality before cataract surgery, refractive lens exchange, or laser refractive surgery.
详细描述
Corneal imaging will be repeated before and after TrueTear use during a single patient visit. Image quality measures will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Scheduled to undergo routine imaging for cataract surgery, refractive lens exchange or laser refractive surgery
排除标准
- •A cardiac pacemaker, implanted or wearable defibrillator, or other implanted metallic or electronic device (e.g. cochlear implant) in the head or neck
- •Chronic or frequent nosebleeds, a bleeding disorder (e.g. hemophilia), or another condition that can lead to increased bleeding
- •A known hypersensitivity (allergy) to the hydrogel material that comes into contact with the inside of the nose during use of the TrueTearTM device
- •Pregnancy
- •Presence of any ocular disease or condition which in the investigator's opinion would confound the study results
结局指标
主要结局
Surface Asymmetry Index (SAI) Assessed With Corneal Topography
时间窗: Change from baseline SAI at 5-10 minutes after using the TrueTear device.
Surface asymmetry index (SAI) is an index that indicates an average value of the corneal power differences between the points spatially located at 180° from 128 equidistant meridians. A radially symmetrical surface has a value of zero, and this value increases as the degree of asymmetry is greater. Higher values are worse, but there is no set maximum value and no unit of measure.
次要结局
- Surface Regularity Index (SRI) Assessed With Corneal Topography(Change from baseline SRI at 5-10 minutes after using the TrueTear device.)