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Shanghai Diabetic Eye Study in Diabetics

Shanghai Eye Disease Prevention and Treatment Center

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03579797
Acronym
SDES
Enrollment
200000
Registered
2018-07-09
Start date
2015-01-01
Completion date
2018-12-31
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Eye Diseases, Diabetic Retinopathy

Keywords

diabetic eye diseases, diabetic retinopathy

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

Interventions

BEHAVIORALScreening, 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.

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual impairmentDecember 31, 2018Visual impairment was present if best corrected visual acuity \<20/25
Glycosylated hemoglobinDecember 31, 2018This test measure the average blood sugar control for the previous three months or so.
Diabetic retinopathyDecember 31, 2018Prevalence of DR and diabetic macular edema. The DR grades are according to the well-acceptedInternational Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale.
Diabetic eye diseasesDecember 31, 2018Prevalence of eye diseases due to diabetes.
Diabetics adherence to Diabetic Eye Diseases StudyDecember 31, 2018Predicting adherence in the research were obtained by Questionnaire for the study participants.
Diabetics satisfaction for the SDESDecember 31, 2018Diabetics satisfaction for the screening study,the community health service centers (CHSC),and the designated medical institutions were obtained by Questionnaire for the study participants.
Referral complianceDecember 31, 2018Referral compliance of diabetics were obtained by Questionnaire and Shanghai eye health information service system for the study participants.
Human resources and ophthalmic equipment resourcesDecember 31, 2018Compared 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.
Eye health managementDecember 31, 2018All the study participants will be recommended appropriate eye health management.

Countries

China

Contacts

Primary ContactHaidong Zou, MD,PhD
zouhaidong@263.net8613311986528
Backup ContactYi Xu, MD,PhD
xxy1982@hotmail.com8613795235166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026