Agreement and Accuracy of Different Devices for Biometry Measurements in Patients With Cataract
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Agreement of the four devices measuring mean keratometry value.
研究概览
简要总结
The rationale of this study is to compare repeatability, reproducibility and agreement of three different AS-OCT devices and Pentacam.
The investigational devices are approved biometry and keratometry devices to perform biometric/keratometric measurements preoperatively before cataract surgery. The measurements are used to calculate the needed IOL power.
Measurements with all four devices will be performed 3 times consecutively by two trained observer. The order of the observer, the order of devices as well as the eye (left/right) is randomized.
Examinations will be implemented in accordance with the approved investigational plan on subjects and includes: repeated biometry/keratometry with four different devices
详细描述
The rationale of this study is to compare repeatability, reproducibility and agreement of both, AS-OCT(s) and Pentacam. In our department three different AS-OCT devices and a HR Scheimpflug imaging device are currently in use for clinical routine to measure the cornea. Among refractive and anterior segment surgeons, there is no preferred and accepted method for accurate measurements of the corneal curvature. The four diagnostic tools are based on different technical and physical imaging principles and to date only limited information on their comparability exist. One advantage of ASOCT represents faster imaging speed when compared to Scheimpflug imaging. Thus, imaging misalignment, segmentation errors and defocus aberration can most likely be avoided by AS-OCT. Chen et al demonstrated that HR Scheimpflug imaging measurements of CCT were systematically higher than the measurements provided by FD AS-OCT. Further, repeatability, reproducibility and agreement of AS-OCT and Scheimpflug imaging device will be assessed during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Which eye as well as the order of devices and observer will be randomized. Randomization information will be put in a sealed envelope on screening date and opened right before measurements start.
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age-related cataract
- •Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
排除标准
- •Contact lens wear within 5 days
- •Pathologic changes of the cornea, eye lid or conjunctiva on slit- lamp examination
- •History of corneal ocular surgery
- •Microphthalmus
- •Recurrent intraocular inflammation of unknown etiology
- •Blind fellow eye
- •Uncontrolled systemic or ocular disease
结局指标
主要结局
Agreement of the four devices measuring mean keratometry value.
时间窗: 1 year
The measured K-Value of each device and the k-values within one device will be compared
次要结局
- Agreement of the four devices measuring mean steep keratometry value.(1 year)
- Agreement of the four devices measuring mean flat keratometry value.(1 year)
- Agreement of the four devices measuring mean true keratometry value.(1 year)
- Agreement of the devices measuring mean axial length(1 year)
- Agreement of the devices measuring mean lens thickness(1 year)
- Agreement of the devices measuring mean white-to-white measurement(1 year)
研究者
Rupert Menapace
Principal Investigator
Medical University of Vienna