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临床试验/NCT02023619
NCT02023619已完成不适用

Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D

SynsLaser Kirurgi AS1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Cornea epithelial thickness distribution

研究概览

简要总结

The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT).

Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.

详细描述

Purpose of the study: To characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection.

Methodology: SD-OCT corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with > 2 diopters (D) of corneal astigmatism as controls (group 2) are studied. Keratoconus patients referred to the Eye Dpt. of the University Hospital North Norway for CXL (Corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at SynsLaser® Kirurgi AS Tromsø clinic are examined by corneal SD-OCT as a part of their routine examination. Analysis of their SD-OCT corneal scans is used for the purpose of this study.Two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a Scheimpflug-based corneal topography) for each individual are obtained by using a RTVue100® (Optovue Inc. Fremont, California, USA), 26000-Hz SD-OCT across the central 6mm diameter of the cornea.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Keratoconus group: Confirmed diagnosis of keratoconus
  • Astigmatism group: Healthy eyes with astigmatism of >2.0 D

排除标准

  • Keratoconus group: Keratoconus > stage 3 on Krumeich scale
  • Astigmatism group: No signs of keratoconus

结局指标

主要结局

Cornea epithelial thickness distribution

时间窗: Up to 24 weeks

A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

次要结局

  • Cornea stromal thickness distribution(Up to 24 weeks)

研究者

发起方
SynsLaser Kirurgi AS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandar Stojanovic

Medical director of SynsLaser Surgery AS

SynsLaser Kirurgi AS

研究点 (1)

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