Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Brief Summary:
Diabetes affects 29.1 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy (DR) and that as many as 8% have severe, vision-threatening forms of DR. Early laser photocoagulation in high-risk proliferative diabetic retinopathy (PDR) has been shown to decrease the relative risk of vision loss by as much as 52%. Injections of anti-VEGF agents preserve and improve vision in people with PDR and/or diabetic macular edema. Despite effective treatment however, tens of thousands of people with diabetes are going blind each year largely because they don't undergo annual screening for retinopathy. Currently, only some 50%-60% of people with diabetes have a yearly eye exam and there may not be enough eye specialists to see the balance.
To address the issue of patient compliance with diabetic retinopathy screening, IDx-DR was developed as an automated screening device designed to analyze fundus images for the presence of lesions and other disease features associated with diabetic retinopathy. This study has been designed to validate the safety and efficacy of the device at the frontlines of healthcare.