Shanghai Cohort Study of Diabetic Eye Disease

Diabetic Retinopathy Visually Threatening Clinical Trial

— SCODE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03665090
• Other study ID #: YFZX2018007
• Status: Enrolling by invitation
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2018
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 8000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Macular Edema of Both Eyes (Diagnosis)
• Diabetic Retinopathy
• Diabetic Retinopathy Visually Threatening
• Eye Diseases
• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Retinal and choroidal thickness	Retinal and choroidal thickness were evaluated on SS-OCT.	December 31, 2018
Secondary	Retinal blood flow	Retinal blood flow were evaluated on SD-OCTA.	December 31, 2018
Secondary	Blood biochemistry indexes	Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc.	December 31, 2018
Secondary	Urine biochemistry indexes	Urine samples were used for testing urine albumin and creatinine.	December 31, 2018
Secondary	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