Clinical trial NCT03579797: Shanghai Diabetic Eye Study in Diabetics
Official title: Shanghai Eye Disease Prevention and Treatment Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Eye Diseases
Diabetic Retinopathy
Keywords: diabetic eye diseases
diabetic retinopathy
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 200000
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Eligibility 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.

Primary outcomes:
measure: Diabetic retinopathy
timeFrame: December 31, 2018
measure: Diabetic eye diseases
timeFrame: December 31, 2018
measure: Visual impairment
timeFrame: December 31, 2018
measure: Glycosylated hemoglobin
timeFrame: December 31, 2018
measure: Diabetics adherence to Diabetic Eye Diseases Study
timeFrame: December 31, 2018
measure: Diabetics satisfaction for the SDES
timeFrame: December 31, 2018
measure: Referral compliance
timeFrame: December 31, 2018
measure: Human resources and ophthalmic equipment resources
timeFrame: December 31, 2018
measure: Eye health management
timeFrame: December 31, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention & Treatment Center
state: Jingan
Study officials:
affiliation: Shanghai Eye Disease Prevention and Treatment Center
name: Haidong Zou, MD，PhD
role: STUDY_CHAIR
References: