Diabetic RetinopathyCSSODRITNCT06478407
Community Screening Study of Diabetic Retinopathy in Tianjin in 2024
An observational study of Diabetic Retinopathy, run by Li Xiaorong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 18,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2024to 28 Mar 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with diabetes receive a unified eye examination in the community to confirm whether they have diabetic retinopathy
Who may be able to join
- 1: Clear awareness, barrier-free communication
- 2: diabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, 300000
Juping Liu, 13752033227, tydljp@126.com
About this study
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
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic retinopathy screening group | Diabetes patients in the community to accept unified eye test, confirm whether patients with diabetic retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of diabetic retinopathy
Fundus images were taken by fundus camera and graded
Measured: At screening
Secondary outcomes (7)
blood routine examination
Blood was collected and tested
Measured: At screening
OCTA imaging indicators
OCTA machine was used to photograph the fundus
Measured: At screening
blood biochemistry
Blood was collected and tested
Measured: At screening
glycosylated hemoglobin
Blood was collected and tested
Measured: At screening
glycated albumin
Blood was collected and tested
Measured: At screening
Urine ACR
Urine was collected and tested
Measured: At screening
Blood vessel color Doppler ultrasound of extremities
Blood vessels of extremities were photographed by color Doppler ultrasound
Measured: At screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start28 Mar 2024
- Primary completion28 Mar 2025 (estimated)
- Study completion28 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 18,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Li Xiaorong
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Responsible party
- Sponsor-investigator, Li Xiaorong, Tianjin Medical University Eye Hospital
- Investigators
- Xiaorong Li, professor, Principal investigator, Tianjin Medical University Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478407
- Sponsor's protocol ID
- 2024
- Acronym
- CSSODRIT
- Status last verified
- Jul 2024
- First submitted
- 22 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Screening Study of Diabetic Retinopathy in Tianjin in 2024
- ClinicalTrials.gov ID
- NCT06478407
- Acronym / sponsor ID
- CSSODRIT / 2024
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Li XiaorongUniversity, hospital or other
- Collaborators
- Tianjin Medical University Eye Hospital
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 28 Mar 2025 (estimated)
- Study completion
- 28 Mar 2025 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic retinopathy screening group | – | –Diabetes patients in the community to accept unified eye test, confirm whether patients with diabetic retinopathy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with diabetes receive a unified eye examination in the community to confirm whether they have diabetic retinopathy
Key inclusion criteria (2 listed)
- 1: Clear awareness, barrier-free communication
- 2: diabetes
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classification of diabetic retinopathy
Time frame: At screening
Fundus images were taken by fundus camera and graded
7 secondary outcomes
blood routine examination
Time frame: At screening
OCTA imaging indicators
Time frame: At screening
blood biochemistry
Time frame: At screening
glycosylated hemoglobin
Time frame: At screening
glycated albumin
Time frame: At screening
Urine ACR
Time frame: At screening
Blood vessel color Doppler ultrasound of extremities
Time frame: At screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaorong Li, professor principal investigator
Tianjin Medical University Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Li Xiaorong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juping Liu, Director (13752033227, tydljp@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classification of diabetic retinopathy (time frame: At screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.