Shanghai Diabetic Eye Study in Diabetics (SDES)
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|ClinicalTrials.gov Identifier: NCT03579797|
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
|Condition or disease||Intervention/treatment|
|Diabetic Eye Diseases Diabetic Retinopathy||Behavioral: Screening, referral, follow-up and health management|
|Study Type :||Observational|
|Estimated Enrollment :||200000 participants|
|Official Title:||Shanghai Eye Disease Prevention and Treatment Center|
|Actual Study Start Date :||January 1, 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- 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.
- Diabetic retinopathy [ Time Frame: 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".
- Diabetic eye diseases [ Time Frame: December 31, 2018 ]Prevalence of eye diseases due to diabetes.
- Visual impairment [ Time Frame: December 31, 2018 ]Visual impairment was present if best corrected visual acuity <20/25
- Glycosylated hemoglobin [ Time Frame: 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 [ Time Frame: December 31, 2018 ]Predicting adherence in the research were obtained by Questionnaire for the study participants.
- Diabetics satisfaction for the SDES [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Eye health management [ Time Frame: December 31, 2018 ]All the study participants will be recommended appropriate eye health management.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579797
|Contact: Haidong Zou, MD，PhDfirstname.lastname@example.org|
|Contact: Yi Xu, MD，PhDemail@example.com|
|Shanghai Eye Disease Prevention & Treatment Center||Recruiting|
|Shanghai, Jingan, China, 380 Kangding Road|
|Contact: Zhu Xiaofeng, MM 8613917916016|
|Sub-Investigator: Zhu Xiaofeng, MM|
|Study Chair:||Haidong Zou, MD，PhD||Shanghai Eye Disease Prevention and Treatment Center|