NCT06748092招募中不适用
Clinical Validation of iCare IC1000 Tonometer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
研究概览
简要总结
Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Investigator cannot see the measurement results.
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
- •Age ≥ 18 years
排除标准
- •Subjects with only one functional eye
- •Subjects having poor or eccentric fixation in the study eye
- •High corneal astigmatism >3D in the study eye
- •Central corneal scarring
- •History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
- •Microphthalmos
- •Buphthalmos
- •Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
- •Dry eyes (clinically significant)
- •Lid squeezers - blepharospasm
- •Nystagmus
- •Keratoconus
- •Any other corneal or conjunctival pathology or infection relevant to this study
- •Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
- •Cataract Extraction within last 2 months in the study eye
结局指标
主要结局
Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
时间窗: Through study completion, an average of 6 months
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on the reference tonometer measurements. The iCare IC1000 Tonometer measurements shall be within +/-5.0 mmHg of the reference tonometer measurements in all groups.
次要结局
- Retrospective analysis of "Quick Measure" mode(Through study completion, an average of 6 months)
研究者
研究点 (2)
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