Evaluation System and Clinical Application for Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT03528720
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Patients with diabetic retinopathy
Refractive interstitial turbidity Cannot cooperate with examiner Retinal surgery in patients Malignant tumors Hematological diseases Immune diseases Glaucoma or other retinal diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The earliest and most frequently occurring fundus quadrant of diabetic retinopathy in fundus fluorescein angiography. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Qianli Meng
🇨🇳Guangzhou, Guangdong, China