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临床试验/NCT03260673
NCT03260673已完成不适用

白内障超声乳化术对 2 型糖尿病患者角膜内皮细胞的影响 Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

Beijing Tsinghua Chang Gung Hospital0 个研究点目标入组 30 人开始时间: 2015年9月1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
30
主要终点
Comparison of the corneal endothelial cell density before-after cataract surgery

研究概览

简要总结

This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

详细描述

The investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.Then, the investigators compared the two sets of data. At last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

研究设计

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

入排标准

年龄范围
58 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the experimental group:
  • Clinical diagnosis of cataract
  • Type 2 diabetes mellitus
  • The recent blood glucose control was stable
  • The glycosylated hemoglobin < 8%
  • The control group:
  • Clinical diagnosis of cataract
  • No history of type 2 diabetes

排除标准

  • Corneal lesions
  • Anterior inflammation
  • Ocular trauma or surgical history
  • Corneal endothelial cell density < 1500 / mm squared

结局指标

主要结局

Comparison of the corneal endothelial cell density before-after cataract surgery

时间窗: half year

Comparison of the corneal endothelial cell density before-after cataract surgery,the density is expressed in terms of the number of cells per square millimeter.

次要结局

  • Comparison of the endothelial cell size before-after cataract surgery(half year)
  • Comparison of the percentage of hexagonal cells before-after cataract surgery(half year)
  • Comparison of the central corneal thickness(CCT) before-after cataract surgery(half year)

研究者

申办方类型
Other
责任方
Sponsor

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