跳至主要内容
临床试验/NCT03528720
NCT03528720
已完成
不适用

Evaluation System and Clinical Application for Diabetic Retinopathy

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 225 人2017年6月13日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Diabetic Retinopathy
发起方
Guangdong Provincial People's Hospital
入组人数
225
试验地点
1
主要终点
The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography.
状态
已完成
最后更新
7年前

概览

简要总结

Diabetic retinopathy(DR) is one of the most common and serious microvascular complications of diabetes,which is the primary cause of vision loss of diabetic patients. The risk of blindness is 25 times that of healthy people.Fundus fluorescein angiography (FFA) is the gold standard for diagnosing the stage of diabetic retinopathy.However,FFA is an invasive examination which requires the patient to be in good physical condition and is not suitable for large-scale screening.Therefore, it is important to build up an evaluation system for early diagnosis of DR,which is more convenient, safer, and non-invasive.Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with optical coherence tomography angiography(angio-OCT) and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR in order to build up a more effective,safer and faster evaluation system and clinical application for DR.

详细描述

Firstly, this study will retrospectively analyze the FFA images of DR to find the earliest and most frequently occurring fundus quadrant.Secondly,based on the retrospective analysis results, a prospective comparative study will be conducted,which combines the fundus photography with angio-OCT and physical indicators to find out whether it has consistency, sensitivity and specificity with FFA in diagnosing the stage of DR.Finally,based on all the results,to build up a more effective,safer and faster evaluation system and clinical application for DR.

注册库
clinicaltrials.gov
开始日期
2017年6月13日
结束日期
2018年4月30日
最后更新
7年前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • Patients with diabetic retinopathy

排除标准

  • Refractive interstitial turbidity Cannot cooperate with examiner Retinal surgery in patients Malignant tumors Hematological diseases Immune diseases Glaucoma or other retinal diseases

结局指标

主要结局

The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography.

时间窗: 2 years

The study is to find the earliest and most frequently occurring fundus quadrant of diabetic retinopathy.Based on the the retrospective analysis results, a prospective comparative study will be conducted to build up a evaluation system and clinical application for diabetic retinopathy.We divided the FFA images into nine quadrants: posterior pole, superior, superior nasal, nasal, inferior nasal, inferior, inferior temporal, temporal, and superior temporal. The qualitative analysis of diabetic retinopathy in each quadrant was performed. The earliest and most common fundus quadrant of diabetic retinopathy was then assessed using a rank sum test, t-test, and analysis of variance.

研究点 (1)

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