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临床试验/NCT06154746
NCT06154746尚未招募不适用

Analysis of Risk Factors in the Development of Diabetic Retinopathy in Assuit University Hospital

Assiut University0 个研究点目标入组 50 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
aeffect of risk factors in progression of diabetic retinopathy.

研究概览

简要总结

The aim of the study is to analyse the risk factors involved in the development of diabetic retinopathy.

详细描述

Introduction Worldwide, diabetic retinopathy (DR) is the leading cause of blindness among working age adults [1]

Diabetes mellitus (diabetes) is a group of conditions in which elevation and dysregulation of blood glucose levels result from either decreased production of insulin or systemic resistance to insulin's effects.

Economic costs of diabetes in the. U.S. in 2012. Diabetes Care. 2013;36(4):1033-46.

Insulin resistance, which often precedes type 2 diabetes, is a component of the metabolic syndrome. Those with diabetes are more likely to have other components of the metabolic syndrome including abdominal obesity, dyslipidemia, hypertension, prothrombotic state, and a proinflammatory state [2] Third Report of the National Cholesterol Education Program. (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-421

Another key point for the development of vascular lesions is the capillary basement membrane thickening as a result of hyperglycemia, increased synthesis of basement membrane components and other factors. This thickening of the basement membrane is related to excess vascular permeability that leads to leaky vessels, compromised tight-junctions and increased vesicular transport [3]

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • All patients with confirmed DR , best-corrected visual acuity BCVA (using a Snellen chart) in each eye to allow the performance of the protocol, and intraocular pressure less than 21 mmHg.
  • . proliferative diabetic retinopathy with or without high-risk characteristics (HRCs) (any three of the following):
  • presence of neovessels
  • location of the neovessels (at the optic nerve)
  • size of the neovessels: if at the optic nerve [neovascularisation of the disc (NVD)] ≥ ¼-⅓ disc area if elsewhere in the retina [neovascularisation of the retina elsewhere (outside the disc) (NVE) ≥ ½ of the disc area (if both NVD and NVE present, classified based on neovessels at the disc)
  • presence of pre-retinal haemorrhage or vitreous haemorrhage. About half of patients with severe or very severe NPDR will progress to PDR within a year.
  • Symptoms include sudden de crease of V/A , appearance of flashes and floaters, visual field defects.

排除标准

  • The exclusion criteria were: DM other than T2DM (such as gestational diabetes); known severe mental illness; a separate advanced or terminal condition; and severe advanced diabetic complications defined as being registered blind, requiring dialysis, or having had an above-the-knee amputation

结局指标

主要结局

aeffect of risk factors in progression of diabetic retinopathy.

时间窗: baseline

analysis of risk factors affecting progression of diabetic retinopathy and test if they can be modified or not.

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

Dalia Mohamed Mahmoud Asem

resident doctor

Assiut University

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Analysis of Risk Factors of Diabetic Retinopathy | 临床试验