Influence of Artificial Tears on Corneal Parameter Measurement Using Three Different Devices: Scheimpflug-, Keratometry - and Placido-technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
研究概览
简要总结
The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:
- Do artificial tears alter the measurements of the corneal surface
- Is there a difference between the devices used in this study
This is relevant because high quality measurements improve the postoperative outcome after cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The investigator and patient knew which device they were tested on
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy eyes
排除标准
- •Any prior intraocular surgery or trauma
- •Any corneal pathology (ABMD, Fuch's, etc.)
- •Active ocular pathology (e.g., amblyopia, ARMD)
- •Contact lens wear within 2 weeks of study
- •Any corneal relaxing incisions or astigmatic keratotomy
研究组 & 干预措施
IOL Master 700
Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: Artificial tear (Drug)
IOL Master 700
Patients in this arm are measured twice with the IOL master 700 without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: No artificial tears (Other)
Pentacam AXL
Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: Artificial tear (Drug)
Pentacam AXL
Patients in this arm are measured twice with the Pentacam AXL without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: No artificial tears (Other)
Galilei G6
Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: Artificial tear (Drug)
Galilei G6
Patients in this arm are measured twice with the Galilei G6 without intervention. After this artificial tears are applied and followed by 4 more measurements
干预措施: No artificial tears (Other)
结局指标
主要结局
Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)
时间窗: Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application
Difference of measurement of the mean corneal refractive power in diopters before artificial tear application and after artificial tear application using one of three devices (IOL Master 700, Pentacam AXL or Galilei G6)
次要结局
- Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?(Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application)
- Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6)(Comparison between the baseline measurements and the measurements 30 seconds after artificial tear application)
- If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?(Comparison between the baseline measurements and the measurements up to 10 minutes after artificial tear applications)
研究者
Professor Dr. med. Thomas Kohnen
Prof. Dr. Thomas Kohnen
University Clinic Frankfurt