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Clinical Trials/NCT06478407
NCT06478407RecruitingNot Applicable

Community Screening Study of Diabetic Retinopathy in Tianjin in 2024

Li Xiaorong1 site in 1 country18,000 target enrollmentStarted: March 28, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
18,000
Locations
1
Primary Endpoint
Classification of diabetic retinopathy

Study Overview

Brief Summary

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.

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 Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Cross Sectional

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Classification of diabetic retinopathy

Time Frame: At screening

Fundus images were taken by fundus camera and graded

Secondary Outcomes

  • glycosylated hemoglobin(At screening)
  • blood routine examination(At screening)
  • glycated albumin(At screening)
  • blood biochemistry(At screening)
  • Blood vessel color Doppler ultrasound of extremities(At screening)
  • OCTA imaging indicators(At screening)
  • Urine ACR(At screening)

Investigators

Sponsor
Li Xiaorong
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Li Xiaorong

PROFESSOR

Tianjin Medical University Eye Hospital

Study Sites (1)

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