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临床试验/NCT05522842
NCT05522842尚未招募不适用

Evaluation of Corneal Endothelium in Diabetic Patients Undergoing Phacoemulsification Using Specular Microscopy

Assiut University0 个研究点目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
corneal endothelial cell size

研究概览

简要总结

evaluate and compare the changes in corneal endothelial cell count density between diabetic and non diabetic patients undergoing phacoemulsification surgery, and to evaluate the effect of duration, and control of diabetes on corneal morphology.

详细描述

Diabetes mellitus (DM) is a major health hazard reaching epidemic proportions. Worldwide more than 285 million people are affected by DM; this number is expected to increase to 439 million by 2030 according to the international diabetes federation. DM affects every part of the body and the eye is not an exception.

Diabetes mellitus has been found to be detrimental to corneal endothelium . Patients with diabetes have been found to have morphologically abnormal endothelium, including pleomorphism and polymegethism. Also, elderly patients with diabetes mellitus undergo phacoemulsification is particularly vulnerable to greater endothelial damage during surgery than non diabetics.

Several studies showed that diabetes mellitus has a lower impact on corneal cell density and morphology in patients with good glycemic control , also patients with diabetes over 10 years have more corneal morphological abnormalities than those having diabetes under 10 years duration.

Patients with DM tend to develop cataract more frequently and earlier than non diabetics.

Corneal endothelium plays an important role in maintaining dehydrated state and transparency of cornea throughout life, by pumping excess fluid out of stroma through active transport mechanism and barrier function. Any compromise in these factors leads to direct effect on corneal endothelium .

研究设计

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

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 40 to 70
  • Any degree of cataract
  • No previous ocular surgery

排除标准

  • Any corneal pathology, infection, or active inflammation
  • pseudoexofoliation
  • History of ocular trauma or surgery

结局指标

主要结局

corneal endothelial cell size

时间窗: baseline

their dimension being roughly 50-70 μm long, 10-30 μm wide and 0.1-10 μm thick

corneal endothelium cell count

时间窗: baseline

normal range of 1500 to 3500 cells/mm2 (age, 40-90)

corneal endothelial cell shape

时间窗: baseline

a single layer of cells organized in a characteristic honeycomb pattern

次要结局

未报告次要终点

研究者

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

Rahma Rashad Helmy

doctor

Assiut University

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