Shanghai Cohort Study of Diabetic Eye Disease

Study Overview
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Brief Summary
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To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.

Detailed Description
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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.

Official Title
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A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease

Conditions
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Diabetic Macular Edema of Both Eyes (Diagnosis), Diabetic Retinopathy Visually Threatening

Intervention / Treatment
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* Behavioral: Diabetic eye disease screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai. Exclusion Criteria: All the study participants have difficulties of mobility or communication.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and incidence rate of diabetic eye disease | 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. | December 31, 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grading of DR | 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. | December 31, 2018 | 
| Retinal and choroidal thickness | Retinal and choroidal thickness were evaluated on SS-OCT. | December 31, 2018 | 
| Retinal blood flow | Retinal blood flow were evaluated on SD-OCTA. | December 31, 2018 | 
| Blood biochemistry indexes | Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc. | December 31, 2018 | 
| Urine biochemistry indexes | Urine samples were used for testing urine albumin and creatinine. | December 31, 2018 | 
| Visual impairment | 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. | December 31, 2018 |