Shanghai Diabetic Eye Study in Diabetics
SDES
Shanghai Eye Disease Prevention and Treatment Center
1 other identifier
observational
200,000
1 country
1
Brief Summary
The purpose of the Shanghai Diabetic Eye Study (SDES) was to guide and regulate eye health screening of two hundred thousand people with diabetes in the communities in 16 districts in Shanghai, build up the ranks with the general practitioner as the backbone combined, and provide comprehensive, continuous, and dynamic information service to diabetic eye disease health management. We expect to form a "screening, finding, referral, follow-up and health management" diabetic eye disease working mode, integrate medical care and precaution closely, promote the classified management and referral, reduce the prevalence rate of diabetic eye disease, blindness and visual impairment of DR, and improve diabetics consciousness of eye health maintenance. At the same time, we will also improve the device configuration of eye health screening and relevant personnel training mechanism in the community health service centers, thus upgrading the level of eye disease prevention and treatment in Shanghai.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 26, 2018
CompletedFirst Posted
Study publicly available on registry
July 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 9, 2018
June 1, 2018
4 years
June 26, 2018
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Diabetic retinopathy
Prevalence of DR and diabetic macular edema. The DR grades are according to the well-accepted"International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale".
December 31, 2018
Diabetic eye diseases
Prevalence of eye diseases due to diabetes.
December 31, 2018
Visual impairment
Visual impairment was present if best corrected visual acuity \<20/25
December 31, 2018
Glycosylated hemoglobin
This test measure the average blood sugar control for the previous three months or so.
December 31, 2018
Diabetics adherence to Diabetic Eye Diseases Study
Predicting adherence in the research were obtained by Questionnaire for the study participants.
December 31, 2018
Diabetics satisfaction for the SDES
Diabetics satisfaction for the screening study，the community health service centers (CHSC)，and the designated medical institutions were obtained by Questionnaire for the study participants.
December 31, 2018
Referral compliance
Referral compliance of diabetics were obtained by Questionnaire and Shanghai eye health information service system for the study participants.
December 31, 2018
Human resources and ophthalmic equipment resources
Compared to human resources and ophthalmic equipment resources in the community health service centers (CHSC)，and the designated medical institutions before and after the SDES by Questionnaire.
December 31, 2018
Eye health management
All the study participants will be recommended appropriate eye health management.
December 31, 2018
Interventions
Field screening, remote diagnosis, comprehensive assessment, referral, and eye health management of diabetics were the main study processes. The community health service centers (CHSC) are responsible for the field screening. The designated medical institutions (DMI) of each district are responsible for the remote diagnosis and comprehensive assessment of diabetic eye diseases, especially diabetic retinopathy (DR), based on comprehensive evaluation through the remote reading system (RRS) and Shanghai eye health information service system (SEHISS). The staff of CHSC urged the referral objects promptly for further diagnosis and treatment in DMI. According to the diagnosis after clinically confirmed, all the study participants will be recommended appropriate eye health management.
Eligibility Criteria
Sampling was carried out in a proportional sampling plan that each diabetic under the archives management aged 35 years and above, residing in Shanghai.
You may qualify if:
- The target population included the adults with diabetes aged 35 years and above under archives management, residing in Shanghai.
You may not qualify if:
- \<35 years old;
- Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Jingan, 380 Kangding Road, China
Biospecimen
The morning urine and the fasting blood will be collected for testing, including blood routine, blood glucose, glycosylated hemoglobin, liver and kidney function, blood lipid, urine microalbumin, urine albumin/creatinine ratio etc.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Haidong Zou, MD，PhD
Shanghai Eye Disease Prevention and Treatment Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Shanghai Eye Disease Prevention and Treatment Center
Study Record Dates
First Submitted
June 26, 2018
First Posted
July 9, 2018
Study Start
January 1, 2015
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 9, 2018
Record last verified: 2018-06