Trials / Completed
CompletedNCT03528720
Evaluation System and Clinical Application for Diabetic Retinopathy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (actual)
- Sponsor
- Guangdong Provincial People's Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2017-06-13
- Primary completion
- 2018-04-30
- Completion
- 2018-04-30
- First posted
- 2018-05-18
- Last updated
- 2018-05-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03528720. Inclusion in this directory is not an endorsement.