Community Screening Study of Diabetic Retinopathy in Tianjin in 2024 (CSSODRIT)

Through this study, the investigators hope to understand the prevalence and influencing factors of diabetic retinopathy in Tianjin, improve the ability of complication detection and intervention in diabetic patients in primary medical and health institutions, and build a diabetes prevention and treatment network. The investigators should adhere to the policy of prevention first, combined with prevention and control, and explore a diabetes' prevention and control model suitable for our city. Extensive publicity and education should be carried out to improve the awareness of self-management ，improve the screening rate of diabetic retinopathy, and reduce the blindness rate.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy

Detailed Description

West of the city, and hebei, heping and binhai new area to carry out the work, diabetic retinopathy screening on 18000 diabetic patients in fundus examination. Tianjin medical university eye hospital, project team, formed in grassroots medical institutions are responsible for screening fundus examination in patients with diabetes, related inspection including vision, computer optometry, fundus photography and optical coherence tomography angiography (OCTA), etc. Blood samples were collected from patients in Hexi District and Heping District to detect glycosylated hemoglobin. Glycated albumin, urine ACR and CO breath test were performed in Chu Hsien-I Memorial Hospital of Tianjin Medical University. Health records were established for the screening personnel after the examination

• Study Type: Observational
• Enrollment (Estimated): 18000

Contacts and Locations

• Study Contact: Name: Juping Liu, Director; Phone Number: 13752033227; Email: tydljp@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Tianjin Medical University Eye Hospital
      • Contact: Juping Liu; Phone Number: 13752033227; Email: tydljp@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with diabetes receive a unified eye examination in the community to confirm whether they have diabetic retinopathy

Description

Inclusion Criteria:

- 1: Clear awareness, barrier-free communication

2: diabetes

Exclusion Criteria:

• 1: Have left the registered home address

  2: In the last 6 months, you have not lived in your place of residence

  3: Have a serious mental illness

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diabetic retinopathy screening group; Diabetes patients in the community to accept unified eye test, confirm whether patients with diabetic retinopathy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of diabetic retinopathy	Fundus images were taken by fundus camera and graded	At screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood routine examination	Blood was collected and tested	At screening
OCTA imaging indicators	OCTA machine was used to photograph the fundus	At screening
blood biochemistry	Blood was collected and tested	At screening
glycosylated hemoglobin	Blood was collected and tested	At screening
glycated albumin	Blood was collected and tested	At screening
Urine ACR	Urine was collected and tested	At screening
Blood vessel color Doppler ultrasound of extremities	Blood vessels of extremities were photographed by color Doppler ultrasound	At screening

Collaborators and Investigators

• Sponsor: Li Xiaorong
• Collaborators: Tianjin Medical University Eye Hospital
• Investigators: Principal Investigator: Xiaorong Li, professor, Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): March 28, 2025
• Study Completion (Estimated): March 28, 2025

Study Registration Dates

• First Submitted: June 22, 2024
• First Submitted That Met QC Criteria: June 22, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: diabetic retinopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: 2024 (Other Grant/Funding Number: Rome Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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