Clinical Evaluation of CATS Tonometer Prism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
研究概览
简要总结
Prospective, open-labeled, randomized, controlled, multicenter study at two clinical investigative sites in Tucson, Arizona. The subjects will undergo intraocular pressure measurement with the CATS tonometer prism and the Goldmann applanation tonometer prism (GAT).
Of the 200 eyes, at least 10 highly astigmatic eyes (>3 D of corneal astigmatism) each in the low, medium and high IOP ranges shall have the same clinical testing and analysis of results, with the analysis kept separate from that of the main group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Written informed consent (and assent when applicable)obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- •Male and female patients, at least 18 years of age
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
- •Subjects with only one functional eye
- •Those with one eye having poor or eccentric fixation
- •Eyes displaying an oval contact image
- •Those with corneal scarring or who have had corneal surgery including corneal laser surgery
- •Microphthalmos
- •Buphthalmos
- •Contact lens wearers
- •Severe Dry eyes
- •Lid squeezers - blepharospasm
- •Nystagmus
- •Keratoconus
- •Any other corneal or conjunctival pathology or infection.
- •Central corneal thickness greater than 0.600 mm or less than 0.500 mm (2 standard deviations about the human mean)
研究组 & 干预措施
Goldmann Tonometer
Goldmann Tonometer prism will be used as a based line comparator for tolerance assessment versus the active test comparator CATS tonometer prism
干预措施: Goldmann tonometer prism (Device)
CATS tonometer
CATS tonometer prism being used as the test product to assess IOP measurement versus active comparator the Goldmann Tonometer prism
干预措施: CATS tonometer prism (Device)
结局指标
主要结局
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings in establishing effectiveness.
时间窗: From date of randomization until 24 hours
次要结局
未报告次要终点