跳至主要内容
临床试验/NCT00838422
NCT00838422
Unknown
不适用

Repeatability and Reproducibility of Pachymetric Mapping With Fourier Domain Optical Coherence Tomography, Ocular Response Analyzer, Confoscan 4 and Ultrasound

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人2008年6月
适应症Keratitis

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Keratitis
发起方
Far Eastern Memorial Hospital
入组人数
100
试验地点
1
主要终点
Repeatability and reproducibility of corneal thickness measurement
最后更新
17年前

概览

简要总结

The purpose of this study is to assess the repeatability, reproducibility, and agreement of central corneal thickness measured by Fourier Domain Optical Coherence tomography (FD-OCT, OptoVue, USA) with anterior corneal module, 20MHz ultrasound pachymetry equipped with Ocular response analyzer (ORA, Reichert Ophthalmic Instruments, USA) and 10MHz Ultrasound Pachymetry (USP).

详细描述

Corneal thickness measurements are clinically important. Variation in corneal thickness affects the accuracy of applanation tonometry. A meta-analysis by Doughty and Zaman showed that a 10% change in central corneal thickness may result in an approximately 3.4-mmHg change in intraocular pressure.1 Accuracy of corneal thickness measurement is also important in considering eligibility for refractive surgery, and the amount of correction that can safely be performed. Underestimation of corneal thickness may lead to eligible patients being excluded for primary or enhancement refractive procedures. Overestimation may lead to over-ablation and inadvertent thinning of the stroma, thereby increasing the risk of iatrogenic keratectasia. Hence, studies assessing corneal thickness measurements by various instruments are of high clinical relevance.2-9 Fourier domain optical coherence tomography (FD-OCT, OptoVue, U.S.A), Confoscan 4 (CS-4, Nidek, USA) and ocular response analyzer (ORA, Reichert, USA) are non-invasive medical devices that have recently received FDA approval for measurement of the cornea thickness. However, the repeatability and reproducibility of these instruments remains unproven in the clinical settings. To our knowledge, this is the first study to describe agreement, repeatability and reproducibility in corneal pachymetric mapping between FD-OCT, ORA, CS-4 and conventional ultrasound (US), which has been the current reference corneal pachymetric mapping system for the majority of refractive surgeons.

注册库
clinicaltrials.gov
开始日期
2008年6月
结束日期
2009年6月
最后更新
17年前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Healthy Volunteers

排除标准

  • Patients who had history of prior ocular surgery, ocular abnormalities other than cataract or refractive error or were unable to cooperate in the examination were excluded.

结局指标

主要结局

Repeatability and reproducibility of corneal thickness measurement

时间窗: 3 months

次要结局

  • Comparing central corneal thickness measurement among FD-OCT, ORA, and USP(3 months)

研究点 (1)

Loading locations...

相似试验