Retinal Vessel Measurements as Clinically Useful Predictors in Veterans

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: Vessel measurements

Detailed Description

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
• Enrollment (Actual): 800

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52246-2208
      • Iowa City VA Health Care System, Iowa City, IA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The investigators will identify a random sample of 4500 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
subjects with diabetes developing hypertension; subjects with diabetes not developing hypertension	Other: Vessel measurements; Measurement of retinal vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the Curve of algorithm	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.	2/1/2016

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Michael Abramoff, MD, Iowa City VA Health Care System, Iowa City, IA

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (ESTIMATE): January 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; computer; retina; analysis; vessel
• Other Study ID Numbers: C1084-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No