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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
Sponsor:
Information provided by (Responsible Party):
Jiannan Huang, 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.

Condition or disease Intervention/treatment
Diabetic Eye Diseases Diabetic Retinopathy 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
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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".

  2. Diabetic eye diseases [ Time Frame: December 31, 2018 ]
    Prevalence of eye diseases due to diabetes.

  3. Visual impairment [ Time Frame: December 31, 2018 ]
    Visual impairment was present if best corrected visual acuity <20/25

  4. Glycosylated hemoglobin [ Time Frame: December 31, 2018 ]
    This test measure the average blood sugar control for the previous three months or so.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Eye health management [ Time Frame: December 31, 2018 ]
    All the study participants will be recommended appropriate eye health management.


Biospecimen Retention:   Samples Without DNA
The morning urine and the fasting blood will be collected for testing, including blood routine, blood glucose, glycosylated hemoglobin, liver and kidney function, blood lipid, urine microalbumin, urine albumin/creatinine ratio etc.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579797


Contacts
Contact: Haidong Zou, MD,PhD 8613311986528 zouhaidong@263.net
Contact: Yi Xu, MD,PhD 8613795235166 xxy1982@hotmail.com

Locations
China, Jingan
Shanghai Eye Disease Prevention & Treatment Center Recruiting
Shanghai, Jingan, China, 380 Kangding Road
Contact: Zhu Xiaofeng, MM    8613917916016      
Sub-Investigator: Zhu Xiaofeng, MM         
Sponsors and Collaborators
Shanghai Eye Disease Prevention and Treatment Center
Investigators
Study Chair: Haidong Zou, MD,PhD Shanghai Eye Disease Prevention and Treatment Center

Responsible Party: Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03579797     History of Changes
Other Study ID Numbers: YFZX2018005
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center:
diabetic eye diseases
diabetic retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases