Diabetic Macular Edema of Both Eyes (Diagnosis)SCODENCT03665090
Shanghai Cohort Study of Diabetic Eye Disease
An observational study of Diabetic Macular Edema of Both Eyes (Diagnosis) and Diabetic Retinopathy Visually Threatening, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Diabetic Macular Edema of Both Eyes (Diagnosis), Diabetic Retinopathy Visually Threatening
- What is being tested?
- Diabetic eye disease screening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2020
- 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: All the enrolled participants got a yearly examination of diabetic eye disease for three years. Considering that the prevalence of DR gradually increases with age, the target population included adults with diabetes aged 35 years and above under archives management, residing in Shanghai. And the study participants were expected to be freely mobile, clear-thinking, and capable of cooperating to complete the ophthalmic examinations.
Who may be able to join
- Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.
Who cannot join
- All the study participants have difficulties of mobility or communication.
About this study
Official title: A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease
To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.
Read the detailed description
The Shanghai Cohort study of Diabetic Eye disease (SCODE) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in Shanghai. Through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on DR.
Meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of DR. Furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and DR.
- Conditions
- Diabetic Macular Edema of Both Eyes (Diagnosis), Diabetic Retinopathy Visually Threatening
- Being tested
- Diabetic eye disease screening
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic eye disease screeningBehavioural
Community-based, prospective cohort study from three consecutive years (2016 to 2018) to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and incidence rate of diabetic eye disease
SCODE was performed to evaluate the prevalence and rate of new cases of diabetic eye disease, especially DR, in a three-year community-based cohort study for the people with diabetes, and to identify the associated factors related with diabetic eye disease.
Measured: December 31, 2018
Secondary outcomes (6)
Grading of DR
Fundus changes were evaluated on non-mydriatic fundus photography and slit-lamp examination. Meanwhile, we will estimate the fundus changes associated with different grade of DR.
Measured: December 31, 2018
Retinal and choroidal thickness
Retinal and choroidal thickness were evaluated on SS-OCT.
Measured: December 31, 2018
Retinal blood flow
Retinal blood flow were evaluated on SD-OCTA.
Measured: December 31, 2018
Blood biochemistry indexes
Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc.
Measured: December 31, 2018
Urine biochemistry indexes
Urine samples were used for testing urine albumin and creatinine.
Measured: December 31, 2018
Visual impairment
Main Cause of visual impairment were determined by two ophthalmologists based on the ophthalmic examinations and reported history. Moreover, we will evaluate the association between the visual impairment and different grade of DR.
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 posted11 Sep 2018
- Study start1 Jan 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular Edema of Both Eyes (Diagnosis)Studies 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
- Prospective
- Enrolment
- 8,000 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665090
- Sponsor's protocol ID
- YFZX2018007
- Acronym
- SCODE
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Xiang Z, Lin S, Xu Y, Lu L, Shi Y, Wang Y, Yang Q, Ling S, Zhou D, Qin X, Cheng M, Zou H, Ma Y. The effects of physical activity on diabetic retinopathy in type 2 diabetes using automated vascular analysis: a cohort study. J Glob Health. 2025 Dec 5;15:04319. doi: 10.7189/jogh.15.04319.
PubMed 41343177
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease
- ClinicalTrials.gov ID
- NCT03665090
- Acronym / sponsor ID
- SCODE / YFZX2018007
- Conditions
- Diabetic Macular Edema of Both Eyes (Diagnosis), Diabetic Retinopathy Visually Threatening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 Sep 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.
To describe the design, methodology and baseline characteristics of the Shanghai Cohort study of Diabetic Eye disease (SCODE) study, a community-based study to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.
Detailed description
The Shanghai Cohort study of Diabetic Eye disease (SCODE) was a three-year community-based study to carry out a regular ocular health screening and epidemiological analysis for diabetic eye disease in the approximately 8,000 middle-aged and elderly people with diabetes in Shanghai. Through this study, we hope to understand the prevalence, epidemic trend and the features of risk factors distribution on diabetic eye disease, especially on DR.
Meanwhile, our aims also included estimating the ocular fundus changes and visual impairment associated with different grade of DR. Furthermore, the aim of the present study was to investigate the association between serum and urine biochemical parameters and DR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the enrolled participants got a yearly examination of diabetic eye disease for three years. Considering that the prevalence of DR gradually increases with age, the target population included adults with diabetes aged 35 years and above under archives management, residing in Shanghai. And the study participants were expected to be freely mobile, clear-thinking, and capable of cooperating to complete the ophthalmic examinations.
Key inclusion criteria (1 listed)
- Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.
Key exclusion criteria (1 listed)
- All the study participants have difficulties of mobility or communication.
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 |
|---|---|---|
| Diabetic eye disease screeningCommunity-based, prospective cohort study from three consecutive years (2016 to 2018) to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai. | Behavioural | – |
Primary outcome
Prevalence and incidence rate of diabetic eye disease
Time frame: December 31, 2018
SCODE was performed to evaluate the prevalence and rate of new cases of diabetic eye disease, especially DR, in a three-year community-based cohort study for the people with diabetes, and to identify the associated factors related with diabetic eye disease.
6 secondary outcomes
Grading of DR
Time frame: December 31, 2018
Retinal and choroidal thickness
Time frame: December 31, 2018
Retinal blood flow
Time frame: December 31, 2018
Blood biochemistry indexes
Time frame: December 31, 2018
Urine biochemistry indexes
Time frame: December 31, 2018
Visual impairment
Time frame: December 31, 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 41343177Xiang Z, Lin S, Xu Y, Lu L, Shi Y, Wang Y, Yang Q, Ling S, Zhou D, Qin X, Cheng M, Zou H, Ma Y. The effects of physical activity on diabetic retinopathy in type 2 diabetes using automated vascular analysis: a cohort study. J Glob Health. 2025 Dec 5;15:04319. doi: 10.7189/jogh.15.04319.
- Individual participant dataSharing planned: Yes. Identified individual participant data for all primary and secondary outcome measures will be made available.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema of Both Eyes (Diagnosis) and Diabetic Retinopathy Visually Threatening, run by Shanghai Eye Disease Prevention and Treatment Center.
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 1 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 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and incidence rate of diabetic eye disease (time frame: December 31, 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665090, which also lists 1 linked publication.
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 11 Sep 2018.