Rationale, Design, and Methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE)

Diabetic retinopathy (DR) is a major microvascular complication of diabetes mellitus. The Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE), a prospective study of a subset of patients in the randomized controlled clinical ACCORD trial, is being conducted at enrollment and aft...

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Bibliographic Details
Published in:The American journal of cardiology 2007-06, Vol.99 (12), p.S103-S111
Main Authors: Chew, Emily Y., MD, Ambrosius, Walter T., PhD, Howard, Letitia T., BA, Greven, Craig M., MD, Johnson, Samantha, MM, Danis, Ronald P., MD, Davis, Matthew D., MD, Genuth, Saul, MD, Domanski, Michael, MD
Format: Article
Language:English
Subjects:
Cardiology
Cardiovascular
Cardiovascular disease
Clinical outcomes
Clinical trials
Coronary Artery Disease - blood
Coronary Artery Disease - prevention & control
Diabetes
Diabetes Mellitus, Type 2
Diabetic Angiopathies - blood
Diabetic Angiopathies - prevention & control
Diabetic retinopathy
Diabetic Retinopathy - blood
Diabetic Retinopathy - prevention & control
Glycated Hemoglobin A
Humans
Medical treatment
Ophthalmology
Randomized Controlled Trials as Topic
Research Design
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Summary:Diabetic retinopathy (DR) is a major microvascular complication of diabetes mellitus. The Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE), a prospective study of a subset of patients in the randomized controlled clinical ACCORD trial, is being conducted at enrollment and after 4 years of follow-up to assess the progression of DR with standardized comprehensive eye exams and fundus photography of 7 standard stereoscopic fields. This study aims to assess the effects of the ACCORD medical treatment strategies of tight control of glycemia and blood pressure and management of dyslipidemia on the course of DR in patients with type 2 diabetes. Photographs will be evaluated at a centralized location using the modified Early Treatment Diabetic Retinopathy Study (ETDRS) classification. The primary outcome of ACCORD-EYE, which will measure the development and progression of DR, is a composite of (1) progression of DR (≥3 steps on the ETDRS scale), (2) photocoagulation for DR, or (3) vitrectomy for DR. Specifically, the following questions will be addressed: (1) Does a therapeutic strategy targeting a glycosylated hemoglobin (HbA1c ) level
ISSN:0002-9149
1879-1913
DOI:10.1016/j.amjcard.2007.03.028