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临床试验/NCT07157553
NCT07157553尚未招募不适用

Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density Among Patients With Proliferative Diabetic Retinopathy .

Assiut University0 个研究点目标入组 45 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
Change in Corneal Endothelial Cell Density (ECD) after PRP

研究概览

简要总结

This study investigates the effect of argon laser panretinal photocoagulation (PRP) on the corneal endothelial cell density (ECD) in patients with proliferative diabetic retinopathy (PDR) by comparing ECD measurements before and after PRP treatment.

详细描述

Proliferative diabetic retinopathy (PDR) is characterized by abnormal neovascularization driven by ischemic retinal tissue hypoxia and elevated vascular endothelial growth factor (VEGF) levels. Argon laser retinal photocoagulation (ALRP) is a standard treatment that applies thermal damage to the retinal pigment epithelium, reducing retinal oxygen demand and VEGF production, thereby causing regression of neovascular vessels. However, the laser light must pass through the anterior eye structures, potentially causing thermal and inflammatory damage to tissues such as the corneal endothelium, which is crucial for maintaining corneal transparency. This prospective observational clinical study conducted at Assuit University Hospital evaluates the impact of ALRP on corneal endothelial cell density using specular microscopy before, 1 week, and 1 month after PRP treatment in newly diagnosed PDR patients. Secondary outcomes include changes in cell morphology such as hexagonality and coefficient of variation, indicative of endothelial cell health and stability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients from either sex with any age newly diagnosed PDR requring PRP .

排除标准

  • history of corneal disease
  • previous intraocular surgery
  • glaucoma or intraocuar inflamation .

结局指标

主要结局

Change in Corneal Endothelial Cell Density (ECD) after PRP

时间窗: baseline

The primary outcome is the quantitative change in the corneal endothelial cell density measured by specular microscopy, comparing pre-treatment baseline values with post-treatment values at 1 week and 1 month intervals. This measure reflects the potential impact of ALRP on the corneal endothelial integrity, crucial for corneal transparency and function.

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

Ahlam Abdelhady Mohamad Omar

resident doctor at Ophthalmology department

Assiut University

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