Shanghai Beixinjing Diabetic Eyes Study

NCT03571217 | Unknown

• 1 other identifier: YFZX2018003
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Visual Impairment; Diabetic Maculopathy

Keywords

Type 2 diabetes mellitus; diabetic retinopathy; visual impairment; diabetic choroidopathy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Diabetic retinopathy cohort

Mild visual impairment cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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.

You may not qualify if:

• None;

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Diabetic Retinopathy; Vision Disorders; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Haidong Zou, MD, PhD

  Shanghai Eye Disease Prevention & Treatment Center

  STUDY CHAIR

Central Study Contacts

Haidong Zou, MD, PhD

CONTACT

8613311986528; zouhaidong@263.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: October 1, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

CN (1)