Shanghai Diabetic Eye Study in Diabetics

NCT ID: NCT03579797

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2018-12-31

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.

Detailed 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

Conditions

Diabetic Eye Diseases; Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Jiannan Huang

Shanghai Eye Disease Prevention and Treatment Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Zou, MD，PhD

Role: STUDY_CHAIR

Shanghai Eye Disease Prevention and Treatment Center

Locations

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Jingan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haidong Zou, MD，PhD

Role: CONTACT

zouhaidong@263.net

8613311986528

Yi Xu, MD，PhD

Role: CONTACT

xxy1982@hotmail.com

8613795235166

Facility Contacts

Zhu Xiaofeng, MM

Role: primary

8613917916016

Other Identifiers

YFZX2018005

Identifier Type: -

Identifier Source: org_study_id