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Shanghai Cohort Study of Diabetic Eye Disease (SCODE)

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ClinicalTrials.gov Identifier: NCT03665090
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center

Brief 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.

Condition or disease Intervention/treatment
Diabetic Macular Edema of Both Eyes (Diagnosis) Diabetic Retinopathy Visually Threatening Behavioral: Diabetic eye disease screening

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.


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Study Type : Observational
Actual Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Three-year Community-based Study in Diabetes: The Shanghai Cohort Study of Diabetic Eye Disease
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Diabetic eye disease screening
    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.


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Grading of DR [ Time Frame: December 31, 2018 ]
    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.

  2. Retinal and choroidal thickness [ Time Frame: December 31, 2018 ]
    Retinal and choroidal thickness were evaluated on SS-OCT.

  3. Retinal blood flow [ Time Frame: December 31, 2018 ]
    Retinal blood flow were evaluated on SD-OCTA.

  4. Blood biochemistry indexes [ Time Frame: December 31, 2018 ]
    Blood samples were used for testing, including glucose, glycosylated hemoglobin (HbA1C), serum lipids, etc.

  5. Urine biochemistry indexes [ Time Frame: December 31, 2018 ]
    Urine samples were used for testing urine albumin and creatinine.

  6. Visual impairment [ Time Frame: December 31, 2018 ]
    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.


Biospecimen Retention:   Samples With DNA
Urine and Blood Sample Collection


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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
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.
Criteria

Inclusion Criteria:

  • Adults with diabetes aged 35 years and above; under archives management; residing in Shanghai.

Exclusion Criteria:

  • All the study participants have difficulties of mobility or communication.

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Responsible Party: Jiannan Huang, Principal Investigator, Shanghai Eye Disease Prevention and Treatment Center
ClinicalTrials.gov Identifier: NCT03665090     History of Changes
Other Study ID Numbers: YFZX2018007
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available with in one year of study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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

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