Shanghai Diabetic Eye Study in Diabetics

• Conditions: Diabetic Eye Diseases; Diabetic Retinopathy

• Registration Number: NCT03579797
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-06-26
• Last Update Submitted: 2018-06-26
• Study First Posted: 2018-07-09
• Last Update Posted: 2018-07-09
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200000

Inclusion Criteria

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

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Exclusion Criteria

• <35 years old;
• Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Eye Disease Prevention & Treatment Center; 🇨🇳 Shanghai, Jingan, China