Diabetic Eye DiseasesSDESNCT03579797
Shanghai Diabetic Eye Study in Diabetics
An observational study of Diabetic Eye Diseases and Diabetic Retinopathy, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetic Eye Diseases, Diabetic Retinopathy
- What is being tested?
- Screening, referral, follow-up and health management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- The target population included the adults with diabetes aged 35 years and above under archives management, residing in Shanghai.
Who cannot join
- <35 years old;
- Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Jingan, 380 Kangding Road
Zhu Xiaofeng, MM, 8613917916016
Zhu Xiaofeng, MM
About this study
Official title: Shanghai Eye Disease Prevention and Treatment Center
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.
Read the 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
- Conditions
- Diabetic Eye Diseases, Diabetic Retinopathy
- Being tested
- Screening, referral, follow-up and health management
- Keywords
- diabetic eye diseases, diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, referral, follow-up and health managementBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: December 31, 2018
Diabetic eye diseases
Prevalence of eye diseases due to diabetes.
Measured: December 31, 2018
Visual impairment
Visual impairment was present if best corrected visual acuity <20/25
Measured: December 31, 2018
Glycosylated hemoglobin
This test measure the average blood sugar control for the previous three months or so.
Measured: December 31, 2018
Diabetics adherence to Diabetic Eye Diseases Study
Predicting adherence in the research were obtained by Questionnaire for the study participants.
Measured: 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.
Measured: December 31, 2018
Referral compliance
Referral compliance of diabetics were obtained by Questionnaire and Shanghai eye health information service system for the study participants.
Measured: 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.
Measured: December 31, 2018
Eye health management
All the study participants will be recommended appropriate eye health management.
Measured: December 31, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center
- Investigators
- Haidong Zou, MD，PhD, Study chair, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579797
- Sponsor's protocol ID
- YFZX2018005
- Acronym
- SDES
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 9 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Eye Disease Prevention and Treatment Center
- ClinicalTrials.gov ID
- NCT03579797
- Acronym / sponsor ID
- SDES / YFZX2018005
- Conditions
- Diabetic Eye Diseases, Diabetic Retinopathy
- Keywords
- diabetic eye diseases, diabetic retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The target population included the adults with diabetes aged 35 years and above under archives management, residing in Shanghai.
Key exclusion criteria (2 listed)
- <35 years old;
- Diabetics should not be able to move freely, clear-thinking and considered possible to cooperatively complete the ophthalmic examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening, referral, follow-up and health managementField 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. | Behavioural | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
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Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidong Zou, MD，PhD study chair
Shanghai Eye Disease Prevention and Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Eye Diseases and Diabetic Retinopathy, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haidong Zou, MD，PhD (8613311986528, zouhaidong@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic retinopathy (time frame: December 31, 2018). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.