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临床试验/NCT04734158
NCT04734158进行中(未招募)不适用

EVALUATION OF CORNEAL EPITHELIAL THICKNESS MAPPING IN DIABETIC PATIENTS USING ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY AND ITS CORRELATION TO MACULAR THICKNESS

Minia University1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2019年8月12日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
153
试验地点
1
主要终点
corneal epithelial thickness

研究概览

简要总结

The corneal epithelium is the outermost layer that covers the front of the eye; it not only functions as a barrier that blocks the passage of foreign material, but also plays an important role in maintaining high optical quality. The stem cells in the basal layer of the limbal epithelium hold a physiological significance in the renewal and metabolism of corneal epithelium, particularly under stressful situations.

详细描述

The cornea in diabetic patients suffers from cellular dysfunction and dysfunctional repairal mechanisms, which include recurrent erosions, delayed wound healing, ulcers, and edema. In addition and undoubtedly related to epithelial dysfunction, alterations in epithelial basement membrane occur.

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

  • The patients aged between 40- 60 years old of both genders.
  • The patients in (Group A) should be diabetics for more than 10 years and free from any other systemic diseases with diabetic macular edema (by OCT).
  • The patients in (Group B) should be diabetics for more than 10 years and free from any other systemic diseases without diabetic macular edema (by OCT).
  • The patients in (Group C) should be free of any systemic diseases and normal macular thickness (by OCT)

排除标准

  • Previous history of any intraocular surgery, intravitreal injection, laser or refractive surgery.
  • Ocular surface disorders (e.g. dry eye) or any corneal pathology.
  • Corneal scars or epithelial dystrophies.
  • Use of any topical medications.
  • Elevated IOP, pregnancy or lactation.

结局指标

主要结局

corneal epithelial thickness

时间窗: 2 years

corneal thickness in diabetics using OCT

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hosny Ahmed Zein

DR. HOSNY AHMED ZEIN

Minia University

研究点 (1)

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