Shanghai Beixinjing Diabetic Eyes Study (SBDES)

The Cohort Study of Incidence and Disk Factors of Diabetic Retinopathy and Visual Impairment in Adults With Type 2 Diabetes

In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy; Visual Impairment; Diabetic Maculopathy

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Haidong Zou, MD, PhD; Phone Number: 8613311986528; Email: zouhaidong@263.net

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Shanghai Eye Disease Prevention & Treatment Center
      • Contact: Haidong Zou, Ph.D; Phone Number: 8613311986528; Email: zouhaidong@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 diabetes mellitus. Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.

Description

Inclusion Criteria:

• ≥18 years old;
• Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.

Exclusion Criteria:

• None;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Diabetic retinopathy cohort
Mild visual impairment cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetic retinopathy	The DR grades are according to the well-accepted ''International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale''	December 31，2024
mild visual impairment	Mild visual impairment was present if BCVA was < 20/25 but ≥ 20/63.	December 31，2024
macular choriocapillaris vessel density(MCVD)	macular choriocapillaris vessel density	December 31，2024
glycosylated hemoglobin	This test measures the average blood sugar control for the previous three months or so.	December 31，2024
retinal thickness (RT)	Retinal thickness was defined as the distance from the internal limiting membrane to the interface of the photoreceptor outer segments and retinal pigment epithelium.	December 31，2024
choroidal thickness (CT)	Choroidal thickness was measured from the outer border of the RPE to the inner border of the choroidoscleral interface.	December 31，2024

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Investigators: Study Chair: Haidong Zou, MD, PhD, Shanghai Eye Disease Prevention & Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; diabetic retinopathy; visual impairment; diabetic choroidopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Sensation Disorders; Macular Degeneration; Retinal Diseases; Diabetic Retinopathy; Vision, Low; Vision Disorders
• Other Study ID Numbers: YFZX2018003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No