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临床试验/NCT02476149
NCT02476149Unknown不适用

Biomechanical Properties of Keratoconic Eyes

University of Plymouth1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
试验地点
1
主要终点
Change of the corneal hysteresis following corneal crosslinking (mmHg)

研究概览

简要总结

In keratoconus (KC) corneal thinning and protrusion can cause myopia and irregular astigmatism, affecting vision. The biomechanical properties of the cornea is maintained by an intricate collagen network, which is responsible for its shape and function. In KC this collagen network is disrupted resulting in the cornea losing its shape and function. Keratoconic changes are focal and localised to certain regions of the cornea and the early detection of these changes is challenging. Screening methods include corneal topography (evaluation of anterior corneal surface curvature), tomography (assessing the morphological features of the anterior segment) and aberrometry (measuring the optical aberrations of the eye). More recent research suggests that the biomechanical destabilization of the cornea may precede topographic and tomographic evidence of KC. Management of KC depends on disease severity with severe cases being treated with keratoplasty and less severe cases with cornealcollagencrosslinking (CXL). CXL is an emerging technique, which aims to increase the biomechanical strength of the keratoconic cornea. Despite strong evidence of changes in the biomechanical properties in human corneas following CXL, there is a significant need for accurate measures of biomechanical changes in vivo pre and post CXL. Until recently technical limitations have restricted the ability to assess the biomechanical properties of the whole cornea in vivo. With the introduction of the CorvisST (Oculus) it is now possible to assess regional biomechanical behaviour of the cornea. The output from the device provides a variety of parameters to indicate the cornea's biomechanical strength. To date, the association between the deflection behaviours in various regions of the cornea in keratoconic eyes preand post CXL has not been studied. In order to effectively assess the clinical benefits of CXL such information is vital. The primary goal of this investigation is to investigate regional biomechanical properties of the keratoconic eye before and after CXL.

研究设计

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

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

  • Adult subjects over the age of 18 with keratoconus who are enrolled for collagen crosslinking treatment

排除标准

  • Any patient who has had surgical complications will also be excluded from participation in the study.
  • Determination during enrolment:
  • Pregnancy or breastfeeding during the study
  • Any kind of systemic disease which affect collagen and the body water regulation system (Marfan syndrome, osteogenesis imperfect, pseudozanthoma elasticum, EhlersDanlos, diabetes, rosacea, acne, cardiovascular disease, thyroid disease)

结局指标

主要结局

Change of the corneal hysteresis following corneal crosslinking (mmHg)

时间窗: Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment

Corneal hysteresis as measured using the CorvisST

次要结局

  • Tear break up time prior to corneal crosslinking (s)(Up to 3 months prior to corneal collagen crosslinking treatment)
  • Axial Length prior to corneal crosslinking (mm)(Up to 3 months prior to corneal collagen crosslinking treatment)
  • Tear break up time following corneal crosslinking (s)(At 3-6 months after treatment)
  • Axial Length axial length following corneal crosslinking (mm)(At 3-6 months after treatment)
  • Change of refractive error following corneal crosslinking (LogMAR)(Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment)
  • Change in corneal curvature following corneal crosslinking (mm)(Up to 3 months prior to corneal collagen crosslinking treatment and at 3-6 months after treatment)

研究者

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

Dr Phillip J Buckhurst

Associate Professor

University of Plymouth

研究点 (1)

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