Diabetes Endothelial Keratoplasty Study (DEKS): Impact of Diabetes and Other Predictors on Corneal Transplant Endothelial Cell Loss and Success
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 570
- 试验地点
- 14
- 主要终点
- Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.
研究概览
简要总结
This multi-center clinical trial is designed to assess the association of diabetes in a cornea donor with transplant success and loss of endothelial cells 5 years following Descemet membrane endothelial keratoplasty (DMEK). Study eyes are assigned to receive either a cornea from a donor without diabetes or a cornea from a donor with diabetes in a masked fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 93 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to return to the study site for follow up at 3 and 5 years after a Descemet membrane endothelial keratoplasty procedure
- •Fluent in English or Spanish
- •Willing to have fingerstick blood sample collected to determine HbA1c level
- •Participated and completed 12-month follow-up in the DEKS study for one or both eyes or a DEKS participant that had a study eye regraft prior to the 12-month visit.
排除标准
- •Lack cognitive capacity such that consent could not be provided.
研究组 & 干预措施
Assigned cornea from a donor without diabetes
Eyes assigned to this arm receive a cornea from a donor without diabetes and undergo Descemet membrane endothelial keratoplasty.
干预措施: Descemet membrane endothelial keratoplasty (Procedure)
Assigned cornea from a donor with diabetes
Eyes assigned to this arm receive a cornea from a donor with diabetes for Descemet membrane endothelial keratoplasty.
干预措施: Descemet membrane endothelial keratoplasty (Procedure)
结局指标
主要结局
Change in central corneal endothelial cell density 5 years after Descemet membrane endothelial keratoplasty.
时间窗: Subjects are followed for 5 years after corneal transplantation.
Central corneal endothelial cell density will be assessed by specular microscopy at 3 and 5 years after Descemet membrane endothelial keratoplasty and the results will be compared with the baseline donor endothelial cell density assessed at the eye bank that provided the donor tissue.
次要结局
未报告次要终点