Shanghai Diabetic Eye Study in Diabetics

Diabetic Retinopathy Clinical Trial

— SDES  

Official title:

Shanghai Eye Disease Prevention and Treatment Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03579797
• Other study ID #: YFZX2018005
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou, MD,PhD
• Phone: 8613311986528
• Email: zouhaidong[@]263.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Community-based cross-sectional samples of the archives management of adults with diabetes aged 35 years and above in 241 community health service centers (CHSC) in 16 districts in Shanghai, were obtained through proportional sampling (32%). Field screening, remote diagnosis, comprehensive assessment, referral, and eye health management of diabetics were the main study processes. Field screening mainly included visual acuity assessment, autorefraction examination, and non-mydriatic fundus photography. 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 of eye and general condition 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• The target population included the adults with diabetes aged 35 years and above under archives management, residing in Shanghai.

Exclusion Criteria:

• <35 years old;

• Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.

Related Conditions & MeSH terms

• Diabetic Eye Diseases
• Diabetic Retinopathy
• Eye Diseases
• Retinal Diseases

Intervention

Behavioral:
• Screening, referral, follow-up and health management
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.

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Jingan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Diabetic eye diseases	Prevalence of eye diseases due to diabetes.	December 31, 2018
Primary	Visual impairment	Visual impairment was present if best corrected visual acuity <20/25	December 31, 2018
Primary	Glycosylated hemoglobin	This test measure the average blood sugar control for the previous three months or so.	December 31, 2018
Primary	Diabetics adherence to Diabetic Eye Diseases Study	Predicting adherence in the research were obtained by Questionnaire for the study participants.	December 31, 2018
Primary	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
Primary	Referral compliance	Referral compliance of diabetics were obtained by Questionnaire and Shanghai eye health information service system for the study participants.	December 31, 2018
Primary	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
Primary	Eye health management	All the study participants will be recommended appropriate eye health management.	December 31, 2018