Comparability of Keratometry and Intraocular Lens (IOL) Calculation of VERION Image Guided System With Established Measuring Devices in Ophthalmologically Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Accuracy of repeatability of keratometry as performed by VERION Image Guided System
研究概览
简要总结
The purpose of this study is to determine if the keratometric functions of the VERION Image Guided System are comparable to those of established keratometric devices (IOLMaster 500, Pentacam HR, LenStar LS900). Calculated intraocular lenses (IOLs) are compared as a clinical consequence of the biometric measurement for IOLMaster 500, LenStar LS900 and VERION Image Guided System.
In addition the comfort and duration of examination in the different devices is evaluated.
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
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
- •All interested individuals
- •Full legal capacity
排除标准
- •Pre-existing or actual ocular disease or pathology, history of ocular surgery
- •Contact lens wear 2 weeks before examination
研究组 & 干预措施
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: Slit lamp (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: Autorefractor (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: IOLMaster 500 (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: Pentacam HR (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: LenStar LS900 (Device)
Opthalmologically healthy individuals
Slit lamp, Autorefractor, IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System
干预措施: VERION Image Guided System (Device)
结局指标
主要结局
Accuracy of repeatability of keratometry as performed by VERION Image Guided System
时间窗: 3 immediate repetitions at study visit (study consists of 1 visit only)
次要结局
- Subjective comfort for test persons as evaluated by questionnaire(Immediately after study visit (study consists of 1 visit only))
- Duration of measurements of each keratometric device as taken by stopwatch(During measurements from placement of head until completion)
- Keratometric values as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System(At study visit (study consists of 1 visit only))
- White-to-White distance as measured by IOLMaster 500, Pentacam HR, LenStar LS900, VERION Image Guided System(At study visit (study consists of 1 visit only))
- Intraocular lens calculation as performed by IOLMaster 500, LenStar LS900, VERION Image Guided System(Immediately after measurement)
研究者
Prof. Dr. med. Mike P. Holzer
Ophthalmologist, FEBO
Heidelberg University