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临床试验/NCT04475900
NCT04475900已完成不适用

Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics - Selection and Evaluation of Eligible Patients With Certain Ocular Diseases Associated With Biomechanical Alterations

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 372 人开始时间: 2020年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
372
试验地点
1
主要终点
New biomechanical parameters of the cornea

研究概览

简要总结

The purpose of this study is the investigation of biomechanical properties of the cornea using computer-aided data analysis. Currently, it is known that keratoconus and glaucoma are ocular disease that are associated with biomechanical alterations of the cornea. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. In glaucoma, the information about corneal alterations serves in two ways, first, correct measurement of intra ocular pressure (IOP); second, early diagnosis of suspects before visual field defects are detectable.

Especially, the Corvis ST is an air-puff tonometer that measures intraocular pressure, corneal thickness (CCT) as well as dynamic corneal response (DCR) parameters. Most of the DCR parameters are affected by IOP and CCT: Therefore, algorithm are needed to determine parameters without impact of IOP and CCT that are describe the biomechanical properties of the cornea.

详细描述

In this study, an eye twin based on finite element modeling is used to measure advanced properties of corneal biomechanics. Raw data of Corvis ST measurement are exported from the device and imported into the model. The outcome of these calculations are merged together and are compared to further clinical findings (e. g. corneal topography and tomography, axial eye length).

Further information were obtained:

Age, sex, refraction, family history, known duration of disease, previous ocular surgery, systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • corneal ectasia (keratoconus) or ectasia suspect
  • glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect

排除标准

  • age under 18 years
  • pregnancy

结局指标

主要结局

New biomechanical parameters of the cornea

时间窗: 2 years

To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings

次要结局

  • Dependence of new biomechanical Parameters of the cornea from influencing factors(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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