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临床试验/NCT02542644
NCT02542644已完成不适用

Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following Descemet's Membrane Endothelial Keratoplasty Using Ultra-high Resolution Optical Coherence Tomography

Medical University of Vienna4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年11月15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
12
试验地点
4
主要终点
Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).

研究概览

简要总结

Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Affected patients complain about blurred vision at early stages of the disease which can progress to blindness. The pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. Additional risk factors that have been identified are female sex, smoking and older age.

While for a long time penetrating keratoplasty (PKP) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. For FECD, this brings the advantage that only the diseased part of the cornea is replaced. Graft detachment has been identified as the main complication following DMEK.

In the investigators' study, an ultra high resolution OCT system will be used to detect graft detachment in patients with FECD after DMEK. With this technique, even small detachments can be visualized. The area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. A follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 98 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged over 18 years scheduled for primary DMEK because of Fuchs' Endothelial Dystrophy

排除标准

  • Any disease inhibiting OCT acquisition; such as blepharospasm, severe tremor or immobility
  • Any previous intraocular surgery other than cataract extraction
  • Previous clinically significant ocular trauma in the study eye, as judged by the investigator
  • Pregnancy, planed pregnancy, or lactating
  • Appointment of a custodian
  • Progressive retinal disease
  • History or presence of glaucoma

结局指标

主要结局

Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).

时间窗: 1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK

Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).

Area of attached graft after DMEK

时间窗: 12 months after DMEK

次要结局

  • Central corneal thickness(12 months)
  • Number of patients in which rebubbling has to be performed(12 months)
  • Number of patients needing retreatment(12 months)
  • Best corrected visual acuity at 6 months using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).(6 months)
  • Corneal endothelial cell count(12 months)
  • Demographic risk factors such as age(12 months)
  • Demographic risk factors such as gender(12 months)
  • Demographic risk factors, such as family history(12 months)
  • Demographic risk factors, such as smoking status(12 months)

研究者

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

Gerhard Garhofer

Assoc. Prof. PD Dr.

Medical University of Vienna

研究点 (4)

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