Shanghai Cohort Study of Diabetic Eye Disease

NCT03665090 | Unknown

• 1 other identifier: YFZX2018007
• Study Type: observational
• Target: 8,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Grading of DR

  December 31, 2018

• Retinal and choroidal thickness

  December 31, 2018

• Retinal blood flow

  December 31, 2018

• Blood biochemistry indexes

  December 31, 2018

• Urine biochemistry indexes

  December 31, 2018

Interventions

Diabetic eye disease screening BEHAVIORAL

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.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Related Publications (1)

• Xiang Z, Lin S, Xu Y, Lu L, Shi Y, Wang Y, Yang Q, Ling S, Zhou D, Qin X, Cheng M, Zou H, Ma Y. The effects of physical activity on diabetic retinopathy in type 2 diabetes using automated vascular analysis: a cohort study. J Glob Health. 2025 Dec 5;15:04319. doi: 10.7189/jogh.15.04319.

  PMID: 41343177 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine and Blood Sample Collection

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 11, 2018
• Study Start: January 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available with in one year of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.