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RecruitingNCT06478407CSSODRITUpdated Jul 10, 2024

Community Screening Study of Diabetic Retinopathy in Tianjin in 2024

An observational study in Diabetic Retinopathy, sponsored by Li Xiaorong. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Li Xiaorong · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
18,000
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Diabetic Retinopathy

Keywords

  • diabetic retinopathy
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's planned enrollment of 18,000 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

Li Xiaorong is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Inclusion criteria

  • 1: Clear awareness, barrier-free communication

2: diabetes

Exclusion criteria

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

05

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
18,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Diabetic retinopathy screening group

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

06

What researchers measure

Primary outcomes

  1. Classification of diabetic retinopathy

    Fundus images were taken by fundus camera and graded

    Time frame: At screening

Secondary outcomes

  1. blood routine examination

    Blood was collected and tested

    Time frame: At screening

  2. OCTA imaging indicators

    OCTA machine was used to photograph the fundus

    Time frame: At screening

  3. blood biochemistry

    Blood was collected and tested

    Time frame: At screening

  4. glycosylated hemoglobin

    Blood was collected and tested

    Time frame: At screening

  5. glycated albumin

    Blood was collected and tested

    Time frame: At screening

  6. Urine ACR

    Urine was collected and tested

    Time frame: At screening

  7. Blood vessel color Doppler ultrasound of extremities

    Blood vessels of extremities were photographed by color Doppler ultrasound

    Time frame: At screening

07

Study locations

1 of 1 sites recruiting
  • Tianjin Medical University Eye Hospital
    Tianjin, Tianjin 300000, China
    Recruiting
08

References and documents

Study documents

  • Study protocol · Jan 26, 2024
  • Informed consent form · Jan 29, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06478407
Lead sponsor
Li Xiaorong
Collaborators
Tianjin Medical University Eye Hospital
Responsible party
Li Xiaorong (PROFESSOR, Tianjin Medical University Eye Hospital) — Sponsor-investigator
First posted
Jun 27, 2024
Start date
Mar 28, 2024
Primary completion
Mar 28, 2025 (estimated)
Completion
Mar 28, 2025 (estimated)
Last update
Jul 10, 2024

Study contacts

Juping Liu, Director
Contact
tydljp@126.com
13752033227
Xiaorong Li, professor
principal investigator · Tianjin Medical University Eye Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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