Retinal Vessel Measurements as Clinically Useful Predictors in Veterans
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/22/2016 |
| Start Date: | February 2013 |
| End Date: | December 2016 |
Diabetic complications are an important source of blindness and mortality among Veterans.
Their occurrence is unpredictable because of the highly variable effect of factors such as
weight, diet and exercise. Improved prediction of diabetes complications has the potential
to improve the care for Veterans with diabetes, especially if this can be done without any
extra effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are
required to undergo annual retinal photography to screen for current diabetic retinopathy.
The investigators have recently developed an automated, precise, fast, novel tool for
measuring retinal vessels in these images. Manual measurement of retinal vessels has shown
that these can predict future -not current- development of hypertension and also diabetic
retinopathy. If the investigators can confirm that their tool can flag those Veterans at
increased risk for developing these diabetes complications, this will allow earlier
intervention and prevention. Because the tool only uses the images that are being taken
anyway, there is no extra effort for either the Veteran or VA staff.
Their occurrence is unpredictable because of the highly variable effect of factors such as
weight, diet and exercise. Improved prediction of diabetes complications has the potential
to improve the care for Veterans with diabetes, especially if this can be done without any
extra effort for the Veterans or their caretakers. All Veterans with diabetes in VHA are
required to undergo annual retinal photography to screen for current diabetic retinopathy.
The investigators have recently developed an automated, precise, fast, novel tool for
measuring retinal vessels in these images. Manual measurement of retinal vessels has shown
that these can predict future -not current- development of hypertension and also diabetic
retinopathy. If the investigators can confirm that their tool can flag those Veterans at
increased risk for developing these diabetes complications, this will allow earlier
intervention and prevention. Because the tool only uses the images that are being taken
anyway, there is no extra effort for either the Veteran or VA staff.
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.
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.
Inclusion Criteria:
- Veterans with diabetes
- from the Greater LA and Iowa City screening programs
- who were imaged at least 3 years ago for DR screening, and did not have hypertension
(AHA definition) at that time
Exclusion Criteria:
- random sample of 500 Veterans with diabetes
- from the Greater LA and Iowa City screening programs
- who were imaged at least 3 years ago for DR screening, and did not have hypertension
(AHA definition) at that time
We found this trial at
1
site
Iowa City, Iowa 52246
Principal Investigator: Michael Abramoff, MD
Phone: 319-338-0581
Click here to add this to my saved trials
