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Retinal Neurodegeneration In Type 2 Diabetes Mellitus Detected by Optical Coherence Tomography

2021年3月19日 更新者:Emel Saad Tawadrous、Assiut University

Retinal Neurodegeneration In Patients With Type 2 Diabetes Mellitus Without Diabetic Retinopathy or With Mild Non Proliferative Diabetic Retinopathy Detected by Optical Coherence Tomography

Evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (DM2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy

研究概览

详细说明

Retinal complications in diabetes mellitus (DM) patients were typically considered part of a vascular process. However, recent studies suggest that ocular degeneration in DM might be caused by 2 different conditions: vasculopathy and neuropathy . For some authors, neuropathy observed in the retina of DM patients might be a part of an underlying polyneuropathy ; for others, however, neuropathic changes might precede microvascular alterations .

Axons of retinal ganglion cells compose the retinal nerve fiber layer (RNFL) in the retina and then form the optic nerve connecting the eyeball and brain. Retinal nerve fiber layer (RNFL) loss is recognized as an important neurodegenerative sign in glaucoma. Thinning of the RNFL has also been found in multiple sclerosis, Parkinson's disease and Alzheimer's disease, indicating neurodegeneration of the retina. If RNFL thinning is significant in diabetic patients with preclinical diabetic retinopathy, evaluation of peripapillary RNFL thickness would be very important, because early detection and treatment of diabetic retinopathy is critical to reduce the risk of blindness Optical coherence tomography (OCT) has been introduced into clinical practice as the most noninvasive and objective method to visualize the retina, showing an amount of detail that resembles histological specimens. Initially, OCT was applied to detect complications of DR (edema macular or epiretinal membrane). Later on, it allowed quantitative and qualitative measurements of retinal thickness and segmentation of all intraretinal layers. OCT might detect early retinal neurodegenerative changes, and thus help define which diabetic patients may be at risk to develop DR.

研究类型

观察性的

注册 (预期的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Emel Saad Tawadrous, MBBCh
  • 电话号码:+201284854021
  • 邮箱emelsaad@ymail.com

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

40 eyes of patients with DM2 and without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy and 40 eyes of healthy controls

描述

Inclusion Criteria:

  • All patients with confirmed type 2 DM diagnosis of at least 6 months
  • Best-corrected visual acuity (BCVA) of 6/12 or higher (using a Snellen chart) in each eye
  • Intraocular pressure (by applanation) less than 21 mmHg.
  • Healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their BCVA is > 6/9 based on the Snellen scale.

Exclusion Criteria:

  • presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images.
  • presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism)
  • intraocular pressure ≥21 mmHg
  • media opacifications
  • concomitant ocular diseases, including history of glaucoma or retinal pathology
  • systemic conditions that could affect the visual system, including neurodegenerative disorders such as Parkinson's disease, multiple sclerosis, or dementia.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:横截面

队列和干预

团体/队列
干预/治疗
DM
Patients With Type 2 Diabetes Mellitus without any signs of diabetic retinopathy or with mild non proliferative diabetic retinopathy
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
Healthy
healthy controls
a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
RNFL thickness
大体时间:Baseline
retinal nerve fiber layer (RNFL) will be evaluated
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2021年6月1日

初级完成 (预期的)

2022年3月1日

研究完成 (预期的)

2022年6月1日

研究注册日期

首次提交

2021年3月18日

首先提交符合 QC 标准的

2021年3月18日

首次发布 (实际的)

2021年3月22日

研究记录更新

最后更新发布 (实际的)

2021年3月23日

上次提交的符合 QC 标准的更新

2021年3月19日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • Neurodegeneration In DM

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