An observational study in Diabetic Eye Diseases and Diabetic Retinopathy, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown at 1 site in China. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2018-07-09.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Observational
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.
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
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's planned enrollment of 200,000 is above the median of 180 across 282 observational studies indexed under Retinal Diseases.
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Sampling was carried out in a proportional sampling plan that each diabetic under the archives management aged 35 years and above, residing in Shanghai.
Exclusion Criteria:
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
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".
Time frame: December 31, 2018
Diabetic eye diseases
Prevalence of eye diseases due to diabetes.
Time frame: December 31, 2018
Visual impairment
Visual impairment was present if best corrected visual acuity \<20/25
Time frame: December 31, 2018
Glycosylated hemoglobin
This test measure the average blood sugar control for the previous three months or so.
Time frame: December 31, 2018
Diabetics adherence to Diabetic Eye Diseases Study
Predicting adherence in the research were obtained by Questionnaire for the study participants.
Time frame: 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.
Time frame: December 31, 2018
Referral compliance
Referral compliance of diabetics were obtained by Questionnaire and Shanghai eye health information service system for the study participants.
Time frame: 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.
Time frame: December 31, 2018
Eye health management
All the study participants will be recommended appropriate eye health management.
Time frame: December 31, 2018
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center