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临床试验/NCT02428166
NCT02428166已完成不适用

Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow Eye

Heidelberg University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Change in maximum keratometry (Kmax) as measured by the Pentacam HR

研究概览

简要总结

The purpose of this retrospective study is to assess corneal changes (keratometry, pachymetry) and change in visual acuity (VA) in keratoconus patients after unilateral crosslinking treatment compared to the untreated fellow eye. The corneal measurements obtained preoperatively and 2 to 14 months postoperatively using a Pentacam rotating scheimpflug camera are analyzed. Furthermore, pre-existing or actual ocular pathology or/and ocular surgeries as potential factors involved in treatment outcome are also evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Keratoconus patients after unilateral crosslinking treatment

排除标准

  • •Morphological changes of the cornea caused be ocular infection or trauma (e.g. corneal scarring)
  • •Other pre-existing corneal surgery (e.g. corneal transplantation, implantation of intrastromal corneal ring segments)

结局指标

主要结局

Change in maximum keratometry (Kmax) as measured by the Pentacam HR

时间窗: after completion of data collection based on the measurements preoperatively and 2-14 months postoperative

次要结局

  • Change in corneal thickness as measured by the Pentacam HR(retrospective analysis from preoperatively to 2-14 months postoperatively)
  • Change in visual acuity (VA)(retrospective analysis from preoperatively to 2-14 months postoperatively)
  • Evaluation of pre-existing ocular pathology or/and ocular surgery as potential factors involved in treatment outcome(retrospective analysis from preoperatively to 2-14 months postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Mike P. Holzer

Ophthalmologist, FEBO

Heidelberg University

研究点 (1)

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