Retinal Vessel Measurements as Clinically Useful Predictors in Veterans
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|ClinicalTrials.gov Identifier: NCT01772173|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment|
|Diabetes||Other: Vessel measurements|
Background: the investigators hypothesize that retinal vessel derived biomarkers, obtained using their automated, precise, fast, novel tool for measuring retinal vessels in retinal images can identify Veterans at increased risk for diabetic retinopathy and hypertension, before any overt signs of retinopathy or increased blood pressure have become apparent. Population studies have shown that changes in arterial and venous diameter are associated with future development of these complications.
Purpose: Determine the potential utility of retinal vessel derived biomarkers, from color fundus photographs, as a non-invasive independent risk factor for diabetic retinopathy (DR) and hypertension in Veterans with diabetes.
Methods: Aim 1. The investigators will evaluate automatically derived retinal vessel parameters (arterial and retinal vessel width and branch relationships) as an early biomarker for future development of hypertension no less than 2 years later, with normal current normal blood pressure. The investigators will compare this biomarker in retinal images from 500 Veterans with diabetes, all of whom did not have hypertension at the time of imaging, for those who were and were not diagnosed with hypertension no more than 3 years later. Aim 2. To evaluate automatically derived retinal vessel parameters as an early biomarker for the risk for development of diabetic retinopathy (defined as transition from less than moderate retinopathy AND no apparent macular edema according to the International Clinical Diabetic Retinopathy and Diabetic Macular Edema Severity Scale) in at risk Veterans with diabetes. The investigators will compare this biomarker in retinal images from a population of 4000 Veterans with diabetes, currently without DR, ~10% of who developed retinopathy no less than two years later while the remainder did not.
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|Official Title:||Retinal Vessel Measurements as Clinically Useful Predictors in Veterans|
|Actual Study Start Date :||February 1, 2013|
|Actual Primary Completion Date :||February 1, 2016|
|Actual Study Completion Date :||March 1, 2017|
subjects with diabetes developing hypertension
subjects with diabetes not developing hypertension
Other: Vessel measurements
Measurement of retinal vessels
- Area under the Curve of algorithm [ Time Frame: 2/1/2016 ]AUC of automatically derived retinal vessel parameters (arterial and retinal vessel width and branch relationships) as an early biomarker for future development of hypertension no less than 2 years later, with normal current normal blood pressure.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772173
|United States, Iowa|
|Iowa City VA Health Care System, Iowa City, IA|
|Iowa City, Iowa, United States, 52246-2208|
|Principal Investigator:||Michael Abramoff, MD||Iowa City VA Health Care System, Iowa City, IA|