Shanghai Cohort Study of Diabetic Eye Disease (SCODE)
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|ClinicalTrials.gov Identifier: NCT03665090|
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment|
|Diabetic Macular Edema of Both Eyes (Diagnosis) Diabetic Retinopathy Visually Threatening||Behavioral: Diabetic eye disease screening|
The Shanghai Cohort study of Diabetic Eye disease (SCODE) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in Shanghai. Through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on DR.
Meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of DR. Furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and DR.
|Study Type :||Observational|
|Actual Enrollment :||8000 participants|
|Official Title:||A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2020|
- Behavioral: Diabetic eye disease screening
Community-based, prospective cohort study from three consecutive years (2016 to 2018) to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.
- Prevalence and incidence rate of diabetic eye disease [ Time Frame: December 31, 2018 ]SCODE was performed to evaluate the prevalence and rate of new cases of diabetic eye disease, especially DR, in a three-year community-based cohort study for the people with diabetes, and to identify the associated factors related with diabetic eye disease.
- Grading of DR [ Time Frame: December 31, 2018 ]Fundus changes were evaluated on non-mydriatic fundus photography and slit-lamp examination. Meanwhile, we will estimate the fundus changes associated with different grade of DR.
- Retinal and choroidal thickness [ Time Frame: December 31, 2018 ]Retinal and choroidal thickness were evaluated on SS-OCT.
- Retinal blood flow [ Time Frame: December 31, 2018 ]Retinal blood flow were evaluated on SD-OCTA.
- Blood biochemistry indexes [ Time Frame: December 31, 2018 ]Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc.
- Urine biochemistry indexes [ Time Frame: December 31, 2018 ]Urine samples were used for testing urine albumin and creatinine.
- Visual impairment [ Time Frame: December 31, 2018 ]Main Cause of visual impairment were determined by two ophthalmologists based on the ophthalmic examinations and reported history. Moreover, we will evaluate the association between the visual impairment and different grade of DR.
Biospecimen Retention: Samples With DNA