Assessment of Measurement Variability Across Automated Biometry Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The Correlation of White-to-white Measurements Between Biometric Devices.
研究概览
简要总结
This is a non-interventional prospective, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers.
详细描述
This is a non-interventional prospective, single center, bilateral, comparative study of white-to-white, corneal thickness, and anterior chamber depth measurements as taken on the Orbscan II compared to the IOL Master 700 (Zeiss), IOL Master 500 (Zeiss), Atlas 9000 (Zeiss), Lenstar 900 (Haag-Streit), Argos (Alcon), iTrace (Tracey), Pentacam (Oculus), and manual calipers. Additional biometric devices or external photography may be included as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ages 18-50 years of age with healthy eyes and no prior ocular surgery
- •At least -1.00 of myopia (spherical equivalent)
- •Able to comprehend and willing to sign informed consent and consent and complete all required testing procedures
- •Clear intraocular media
排除标准
- •Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
- •History of or current retinal conditions or predisposition to retinal conditions
- •Amblyopia or strabismus in either eye
- •History of or current anterior or posterior segment inflammation of any etiology
- •Any form of neovascularization on or within the eye
- •Glaucoma (uncontrolled or controlled with medication)
- •Optic nerve atrophy
- •Subjects with diagnosed degenerative eye disorders
- •Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. connective tissue disease, immunocompromised, clinically significant atopic disease, etc.)
结局指标
主要结局
The Correlation of White-to-white Measurements Between Biometric Devices.
时间窗: Day of visit
The determination of the degree of correlation of white-to-white measurements between various biometric devices and the Orbscan II.
The Correlation of Anterior Chamber Depth Measurements Between Biometric Devices.
时间窗: Day of visit
The determination of the degree of correlation of anterior chamber depth measurements between various biometric devices and the Orbscan II.
The Correlation of Corneal Thickness Measurements Between Biometric Devices.
时间窗: Day of visit
The determination of the degree of correlation of corneal thickness measurements between various biometric devices and the Orbscan II.
次要结局
未报告次要终点