跳至主要内容
临床试验/NCT04527523
NCT04527523终止不适用

Incidence of Post-operative Cystoid Macular Edema: A Prospective Study Comparing DMEK, DSEK, and DSO

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Severity of Post-Op CME

研究概览

简要总结

This study aims to evaluate and compare incidence of post-operative cystoid macular edema (CME) after Descemet Membrane Endothelial Keratoplasty (DMEK), Descemet's Stripping Automated endothelial Keratoplasty (DSEK) and Descemet Stripping Only (DSO).

详细描述

Patients that are undergoing any of these procedures will be asked if they are willing to have a baseline pre-operative Optical Coherence Tomography (OCT) scan completed within 4 weeks of surgery. Additional OCT scans will be collected during routine follow up care. It is hypothesized that the rates of CME will be lower with DSO compared to DMEK and DSEK.

研究设计

研究类型
Observational
观察模型
Other
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

  • Any patient that is undergoing DSO or endothelial corneal transplantation vis DMEK or DSEK

排除标准

  • Patients that do not have an optical coherence tomography measurement pre- operatively
  • Patients that don't have an optical coherence tomography measurement post- operatively
  • Patients with a previous history of uncontrolled macular edema

结局指标

主要结局

Severity of Post-Op CME

时间窗: 3 months post-operative

The severity of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO that experience Cystoid Macular Edema after surgery - measured by net change of Central Foveal Thickness on Optical Coherence Tomography (OCT- is an imaging technique that uses low-coherence light to capture micrometer-resolution, two- and three-dimensional images from within optical scattering media, e.g., biological tissue)

Incidence of Post-Op CME

时间窗: 3 months post-operative

The frequency (number of Subjects) of post-operative Cystoid Macular Edema will be evaluated for patients receiving DMEK, DSEK or DSO.

次要结局

  • Graft Detachment(6 weeks and 3 months post-operative)
  • Infection(6 weeks and 3 month post-operative)
  • Re-bubbling Procedure(6 weeks and 3 months post-operative)
  • Final Visual Acuity(3 months post-operative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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