Repeatability and Reproducibility of Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT and ArcScan Insight 100 Very High-frequency Digital Ultrasound and Comparison Between Devices

London Vision Clinic2 个研究点分布在 1 个国家目标入组 242 人开始时间: 2022年9月1日最近更新: 2022年4月26日

适应症

试验速览

阶段: 不适用
状态: 暂停
发起方: London Vision Clinic
入组人数: 242
试验地点: 2
主要终点: Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in post-op eyes

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the repeatability and reproducibility of corneal, epithelial, and LASIK flap thickness using the Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT, and ArcScan Insight 100 very high-frequency digital ultrasound arc-scanner.

详细描述

Very high-frequency (VHF) digital ultrasound was first used in 1993 to obtain images and measure the thickness of the cornea (the window at the front of the eye) and the layers within the cornea, such as the epithelium (the layer of skin on the surface of the cornea). A commercially available instrument, known as the Artemis, has been used in routine clinical practice since 2001. The ArcScan Insight 100 VHF digital ultrasound scanner is an updated version, which obtained CE mark in 2016.

Optical coherence tomography (OCT) is another method of measuring the thickness of the cornea and the corneal epithelium. OCT has been used for measuring corneal thickness since 1997 and the technology had evolved to also measure epithelial thickness since 2012. There are currently three OCT scanners capable of measuring epithelial thickness; Carl Zeiss Meditec Cirrus HD OCT 5000, Optovue RTVue OCT, CSO MS-39 OCT.

The aim of the study is to establish the repeatability (i.e. the variability in measurements taken by a single examiner during a single visit) and reproducibility (i.e. the variability in measurements taken in the same conditions between two examiners) for each of the four devices for measuring corneal thickness and epithelial thickness.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 21 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Only patients who are medically suitable for corneal laser refractive surgery can be included in the study.
•As general inclusion criteria the following aspects are defined:
•Subjects should be 21 years of age or older.
•Contact lens wearers must stop wearing their contact lenses at least four weeks per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
•Patient will be able to understand the patient information and willing to sign an informed consent.
•For the normal eye populations:
•Eyes with no ocular pathology
•Eyes with no previous ocular or corneal surgery
•For the post-op eye populations:
•Eyes between 3 and 9 months after LASIK or SMILE

排除标准

•Previous ocular or corneal surgery (for normal eyes)
•Patient not being able to tolerate local or topical anesthesia
•Patient has active conjunctivitis or any active ocular infection or inflammation
•Patient has a corneal ulcer
•Patient has an open wound on the corneal epithelium
•Patient has compromised epithelium (e.g. ≥Grade 3 superficial punctate keratitis)
•Pregnancy

结局指标

主要结局

Difference in corneal thickness measurements between Cirrus HD OCT 5000, RTVue OCT, MS-39 OCT, and Insight 100 VHF digital ultrasound in post-op eyes

时间窗: 20 minutes for all four scans

The difference between each pair of devices for corneal thickness, epithelial thickness and interface thickness in eyes between 3 and 9 months after corneal laser refractive surgery

Repeatability and reproducibility of MS-39 OCT corneal scans in normal eyes (standard deviation)