NCT06266351已完成不适用
EVALUATION of CATS TONOMETER PRISM in LASIK SUBJECTS
Intuor Technologies, Inc.2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2024年2月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- IOP measurement difference between CATS and GAT in LASIK patients
研究概览
简要总结
The CATS Tonometer prism clinical study is intended to determine repeatability of intraocular pressure measurement in human corneas which have undergone a LASIK procedure when compared to a standard Goldmann prism, validating the human LASIK eye findings comparing CATS Tonometer and Goldmann prisms to intracameral pressure in cadaver eyes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must meet the following inclusion criteria to be eligible to participate in this clinical trial:
- •At least 22 years of age and undergone LASIK treatment
- •Subject has a clear understanding, English speakingand agrees to all the conditions of the informed consent form
排除标准
- •Subjects will be excluded from participation if they meet the following criteria:
- •Subject has undergone ocular surgery within the last 3 months or LASIK within 6 months
- •Pregnant or nursing women
- •Those who have had previous corneal surgery excluding LASIK
- •Keratoconus
- •Corneal scarring
- •Microphthalmos
- •Buphthalmos
- •Dry eyes with clinical epithelial breakdown upon exam
- •Lid squeezers - blepharospasm
- •Nystagmus
- •Corneal or conjunctival infection.
结局指标
主要结局
IOP measurement difference between CATS and GAT in LASIK patients
时间窗: single measurement 1 day
IOP measurement
次要结局
未报告次要终点
研究者
研究点 (2)
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