Shanghai Beixinjing Diabetic Eyes Study

Diabetic Retinopathy Clinical Trial

— SBDES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571217
• Other study ID #: YFZX2018003
• Status: Recruiting
• Start date: October 1, 2014
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2018
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou, MD, PhD
• Phone: 8613311986528
• Email: zouhaidong[@]263.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetic Maculopathy
• Diabetic Retinopathy
• Retinal Diseases
• Vision Disorders
• Vision, Low
• Visual Impairment

Locations

Country	Name	City	State
China	Shanghai Eye Disease Prevention & Treatment Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	mild visual impairment	Mild visual impairment was present if BCVA was < 20/25 but = 20/63.	December 31,2024
Primary	macular choriocapillaris vessel density(MCVD)	macular choriocapillaris vessel density	December 31,2024
Primary	glycosylated hemoglobin	This test measures the average blood sugar control for the previous three months or so.	December 31,2024
Primary	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
Primary	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