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
- 38
- 试验地点
- 2
- 主要终点
- All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.
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). Seventy-five (75) Subjects 18 and older and will be enrolled. Subjects will be screened based on standard of care vision examination at the clinical investigation sites. All subjects will undergo a standard ophthalmic exam and informed consent. IOP will be measured using a Goldmann tonometer armature with both the standard flat GAT prism and the modified curved CATS prism alternately inserted. The only additional measurement is central corneal thickness (CCT) which is used to correct for one of the corneal biomechanical errors seen in the GAT prism and is currently standard of care.
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 between 0.600 mm and 0.500 mm (more than 2 standard deviations about the human mean)
结局指标
主要结局
All subjects will have corneal thickness measurements performed and the CATS tonometer prism intraocular pressure readings will be compared to Goldmann tonometer readings using a correction value table.
时间窗: From date of randomization until 24 hours
All subjects will have CATS tonometer prism intraocular pressure readings compared to Goldmann tonometer prism readings.
时间窗: From date of randomization until 24 hours
次要结局
未报告次要终点