A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02963441|
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : January 17, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||900 participants|
|Official Title:||A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 2017|
- To determine the sensitivity and specificity of IDx-DR to diabetic retinopathy in the primary care setting [ Time Frame: Day 1 ]