临床试验/NCT06196333

NCT06196333尚未招募不适用

Evaluation of Corneal Endothelium by Specular Microscope in Elderly Diabetic Patients

Assiut University0 个研究点目标入组 100 人开始时间: 2024年2月5日最近更新: 2024年1月9日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Assiut University
入组人数: 100
主要终点: Endothelial count

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

A low endothelial count with endothelial pump dysfunction can contribute to corneal stromal hydration and loss of vision that can only be reversed by corneal transplantation,so this research proposed to detect any corneal endothelial changes related to DM , its duration and control of diabetes.

详细描述

To establish any correlation between endothelial changes , and the duration of diabetes, hemoglobin A1c (HbA1c) by using specular microscope to do morphological examination of corneal endothelial cells, makes the measurement of mean cell density (MCD), measurement of coefficient of variation (CV) in the cell size as well as hexagonal appearance of the cell. These parameters provide the functional status index of the corneal endothelial layer .

研究设计

研究类型: Observational
观察模型: Other
时间视角: Cross Sectional

入排标准

年龄范围: 40 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•- Diabetic patient type 2
•Elderly patients above 40 years old

排除标准

•- Patients with any of the following conditions have been omitted from the study included a past medical history of ocular trauma, corneal or intraocular inflammation, the use of systemic drugs that could affect endothelial cells, evidence of endothelial disease during a slit-lamp examination, previous ocular surgery (including cataract surgery), increased intraocular pressure, corneal opacity, or retinal photocoagulation procedures.
•non of the inclusion criteria patients

结局指标

主要结局

Endothelial count

时间窗: 15 months

Corneal endothelial cell count, coefficient of variation, percentage of hexagonal cells and central corneal thickness will be evaluated and correlated to known normal values in the same healthy individual age group

次要结局

Correlated change(15 months)

研究者

发起方

Assiut University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Abanoub Hennis Mahrous

Resident doctor

Assiut University

相似试验

撤回

不适用

Specular Microscopy StudyEndotheliopathies

NCT02478970University of Michigan

已完成

不适用

Evaluation of Corneal Endothelium of Corneal Endothelial Disease and Post-keratoplasty by Wide Field Contact Specular MicroscopeCorneal endothelial disease, Post-keratoplasty, Post-glaucoma surgery

JPRN-UMIN000021264Kyoto Prefectural University of Medicine54

招募中

不适用

aterality of corneal endothelial cell density after penetrating keratoplasty(PKP) or Descemet's stripping automated endothelial keratoplasty(DSAEK)Patients after PKP or DSAEK

JPRN-UMIN000011657Saneikai Tsukazaki Hospital50

招募中

不适用

Assessment of corneal endothelial cell density: automated and manual measurements with specular photography compared to manual measurements with the confocal microscope.

NL-OMON40876Oogziekenhuis Rotterdam40

已完成

4 期

A study to evaluate the safety profile of phacoemulsification on corneal endothelium in different grades of cataract

CTRI/2019/10/021696Regional Institute of Ophthalmology195