Cross Linking Corneal Biomechanical Evaluation of CATS Tonometer Prism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- IOP measurement
研究概览
简要总结
The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
详细描述
This clinical trial is a prospective, controlled, study and will be performed at one clinical investigative sites in Tucson Arizona1. The purpose of this study is to determine if the device, CATS tonometer prism, measures intraocular pressure significantly differently than the current standard of care tonometer prism (Goldmann) before and after a corneal crosslinking procedure. This difference would be a measurement of the amount of corneal biomechanical changes made due to the cross-linking procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, at least 18 years of age
- •Subject has a clear understanding and agrees to all the conditions of the informed consent form
排除标准
- •• Subject has undergone ocular surgery within the last 3 months
- •Uncontrolled systemic disease that in the opinion of the Investigator would put the subject's heath at risk
- •Pregnant or nursing women
- •Those who have had corneal surgery including corneal laser surgery
- •Microphthalmos
- •Buphthalmos
- •Severe Dry eyes
- •Lid squeezers - blepharospasm
- •Nystagmus
- •corneal or conjunctival infection.
结局指标
主要结局
IOP measurement
时间窗: 6 months
comparative IOP measurement between CATS and GAT tonometer prisms
次要结局
未报告次要终点