Shanghai Cohort Study of Diabetic Eye Disease (SCODE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy Visually Threatening; Diabetic Macular Edema of Both Eyes (Diagnosis)
• Intervention / Treatment: Behavioral: Diabetic eye disease screening

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 Type: Observational
• Enrollment (Actual): 8000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All the enrolled participants got a yearly examination of diabetic eye disease for three years. Considering that the prevalence of DR gradually increases with age, the target population included adults with diabetes aged 35 years and above under archives management, residing in Shanghai. And the study participants were expected to be freely mobile, clear-thinking, and capable of cooperating to complete the ophthalmic examinations.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema; Eye Diseases
• Other Study ID Numbers: YFZX2018007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available with in one year of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No