Shanghai Cohort Study of Diabetic Eye Disease

• Conditions: Diabetic Macular Edema of Both Eyes (Diagnosis); Diabetic Retinopathy Visually Threatening

• Registration Number: NCT03665090
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Brief Summary

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

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 Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2018-08-30
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-06
• Last Update Submitted: 2018-09-06
• Study First Posted: 2018-09-11
• Last Update Posted: 2018-09-11
• Primary Completion: 2018-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

• Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.

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Exclusion Criteria

• All the study participants have difficulties of mobility or communication.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and incidence rate of diabetic eye disease	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.

Secondary Outcome Measures

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