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临床试验/NCT05838898
NCT05838898尚未招募不适用

Changes of Corneal Endothelial Cells in Patients With PDR Using Specular Microscopy

Assiut University0 个研究点目标入组 60 人开始时间: 2023年6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
60
主要终点
To predict the effect of Diabetes on the cornea of diabetic patients

研究概览

简要总结

.1. corneal endothelial profile in patients with proliferative diabetic retinopathy compared to a healthy age-matched control group.

  1. The effect of the age, and duration of Diabetes on the corneal endothelium .

详细描述

Diabetes mellitus (DM) is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels. In Egypt, diabetes is a growing public health problem.

Diabetes causes several ocular complications including diabetic retinopathy, cataract, glaucoma and ocular surface diseases.

Retinal damage caused by microangiopathy results in diabetic retinopathy which is one of the most important causes of blindness and affects approximately 40% of all diabetic patients.

Diabetic retinopathy is classified to non-proliferative diabetic retinopathy (NPDR) (mild, moderate, severe) and proliferative diabetic retinopathy (PDR) according to the severity of retinopathy.

Even though diabetic retinopathy is the most common sequel and most widely studied association of DM, other structures of the eye are not immune and get affected in various stages of the disease.

研究设计

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

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

  • patients with Type I or II Diabetes Mellitus
  • .Diagnosed with proliferative diabetic retinopathy . .Intraocular pressure less than 21mmHg.
  • Healthy controls:
  • .Healthy individuals aged 40 to 70 years of both sexes. .Intraocular pressure less than 21 mmHg.

排除标准

  • Diabetic group:
  • Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
  • Previous ocular trauma or surgery.
  • Healthy control:
  • Any systemic diseases that may affect corneal endothelium function.
  • Associated ocular diseases that may affect the corneal endothelium such as uveitis, glaucoma, and dystrophy, prolonged CLs use.
  • Previous ocular trauma , surgery ,laser or intraocular injection.

结局指标

主要结局

To predict the effect of Diabetes on the cornea of diabetic patients

时间窗: Baseline

To evaluate corneal endothelial changes in patients with Proliferative diabetic retinopathy compared to normal group of the same age and gender using Specular microscopy

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

Marline Reda Fahim Anis

Ophthalmologist

Assiut University

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