Clinical Validation of a Slit Lamp Mounted Rebound Tonometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 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 ST500 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
- •Patients at least 18 years old
排除标准
- •Subjects with only one functional eye
- •Subjects having poor or eccentric fixation in the study eye(s)
- •High corneal astigmatism >3D in the study eye(s)
- •Central corneal scarring
- •History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
- •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
- •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(s)
- •Cataract Extraction within last 2 months in the study eye(s)
研究组 & 干预措施
iCare ST500 vs GAT and iCare IC200
Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg).
干预措施: iCare ST500 (Device)
iCare ST500 vs GAT and iCare IC200
Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg).
干预措施: GAT (Device)
iCare ST500 vs GAT and iCare IC200
Measurement of intraocular pressure (IOP) with iCare ST500 compared to GAT and iCare IC200. Measurements will be performed in three categories: Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (≥23 mmHg).
干预措施: iCare IC200 (Device)
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 4 months
Subjects will be distributed into Low IOP, Medium IOP, and High IOP groups based on Goldmann Applanation Tonometer measurements. The iCare ST500 Tonometer measurements will be within +/-5.0 mmHg of the Goldmann Applanation Tonometer measurements in all groups.
次要结局
未报告次要终点