NCT06478407

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

June 22, 2024

Last Update Submit

July 7, 2024

Conditions

Keywords

diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • Classification of diabetic retinopathy

    Fundus images were taken by fundus camera and graded

    At screening

Secondary Outcomes (7)

  • blood routine examination

    At screening

  • OCTA imaging indicators

    At screening

  • blood biochemistry

    At screening

  • glycosylated hemoglobin

    At screening

  • glycated albumin

    At screening

  • +2 more secondary outcomes

Study Arms (1)

Diabetic retinopathy screening group

Diabetes patients in the community to accept unified eye test, confirm whether patients with diabetic retinopathy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 1: Clear awareness, barrier-free communication
  • : diabetes

You may not qualify if:

  • : Have left the registered home address
  • : In the last 6 months, you have not lived in your place of residence
  • : Have a serious mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Midstream clean urine

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Xiaorong Li, professor

    Tianjin Medical University Eye Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juping Liu, Director

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

June 22, 2024

First Posted

June 27, 2024

Study Start

March 28, 2024

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations