Shanghai Diabetic Eye Study in Diabetics (SDES)

Shanghai Eye Disease Prevention and Treatment Center

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy; Diabetic Eye Diseases
• Intervention / Treatment: Behavioral: Screening, referral, follow-up and health management

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 Type: Observational
• Enrollment (Anticipated): 200000

Contacts and Locations

Study Locations

• China
  • Jingan
    • Shanghai, Jingan, China, 380 Kangding Road
      • Recruiting
      • Shanghai Eye Disease Prevention & Treatment Center
      • Contact: Zhu Xiaofeng, MM; Phone Number: 8613917916016
      • Sub-Investigator: Zhu Xiaofeng, MM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sampling was carried out in a proportional sampling plan that each diabetic under the archives management aged 35 years and above, residing in Shanghai.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Chair: Haidong Zou, MD,PhD, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: diabetic retinopathy; diabetic eye diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Eye Diseases
• Other Study ID Numbers: YFZX2018005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No