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临床试验/NCT03579797
NCT03579797Unknown不适用

Shanghai Eye Disease Prevention and Treatment Center

Shanghai Eye Disease Prevention and Treatment Center1 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200,000
试验地点
1
主要终点
Diabetic eye diseases

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Diabetic eye diseases

时间窗: December 31, 2018

Prevalence of eye diseases due to diabetes.

Visual impairment

时间窗: December 31, 2018

Visual impairment was present if best corrected visual acuity \<20/25

Diabetics satisfaction for the SDES

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: December 31, 2018

Predicting adherence in the research were obtained by Questionnaire for the study participants.

Eye health management

时间窗: December 31, 2018

All the study participants will be recommended appropriate eye health management.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiannan Huang

Shanghai Eye Disease Prevention and Treatment Center

Shanghai Eye Disease Prevention and Treatment Center

研究点 (1)

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