Evaluation of Repeatability in Measurements of Two Swept-source Optical Coherence Tomography (Ss-OCT) Biometers and One Optical Low Coherence Reflectometry (OLCR) Biometer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of repeatability between two ss-OCT and one OLCR biometry device
研究概览
简要总结
Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.
Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.
详细描述
Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.
ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.
This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient.
Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.
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
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years old or above
- •age-related cataract
排除标准
- •patients with dense cataract or corneal pathology that would significantly influence biometric measurements
- •nystagmus or pathologies that would affect patient fixation
- •pregnancy- for women in reproductive age a pregnancy test will be performed.
结局指标
主要结局
Evaluation of repeatability between two ss-OCT and one OLCR biometry device
时间窗: 8 months
Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation between two ss-OCT and the OLCR biometry device will be calculated for all the parameters (axial length, keratometry, anterior chamber depth, lens thickness)
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Head of the Ophthalmology Department, and Principal Investigator
Vienna Institute for Research in Ocular Surgery