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Shanghai Cohort Study of Diabetic Eye Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03665090
Acronym
SCODE
Enrollment
8000
Registered
2018-09-11
Start date
2016-01-01
Completion date
2020-12-31
Last updated
2018-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALDiabetic 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.

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence and incidence rate of diabetic eye diseaseDecember 31, 2018SCODE 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

MeasureTime frameDescription
Grading of DRDecember 31, 2018Fundus 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 thicknessDecember 31, 2018Retinal and choroidal thickness were evaluated on SS-OCT.
Retinal blood flowDecember 31, 2018Retinal blood flow were evaluated on SD-OCTA.
Blood biochemistry indexesDecember 31, 2018Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc.
Urine biochemistry indexesDecember 31, 2018Urine samples were used for testing urine albumin and creatinine.
Visual impairmentDecember 31, 2018Main 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026