Clinical Trial Makes Diabetic Retinopathy Screening Available in Primary Care Setting

Seema Garg, MD, PhD, is leading a study that uses telemedicine and new imaging technology to offer a convenient retinal screening method for patients with diabetes at risk for vision loss. Tom Miller, MD, is integrating the innovative technology into UNC’s clinical setting.

Clinical Trial Makes Diabetic Retinopathy Screening Available in Primary Care Setting click to enlarge Retina image using new camera technology

The study – which started enrolling patients in May – is a program that offers ultra-widefield (UWF) retinal imaging to screen for diabetic retinopathy in an integrated health care setting. Seema Garg, MD, PhD, associate professor of ophthalmology, says there are multiple novel aspects to this study.

Garg and fellow investigators are using new camera technology which is able to image 200 degrees of the retina instead of the typical 45 to 50 degrees. The camera is non-mydriatic, that is, no pupillary dilation is required.  As part of the telemedicine infrastructure, the images are uploaded to a secure HIPAA-compliant website and are remotely interpreted by retina specialists, such as Dr. Garg. Within 24 to 48 hours, a report containing the preliminary diagnosis and management plan is sent back to the patient and their primary care provider to discuss next steps.  Patients with a certain degree of retinopathy are referred to an ophthalmologist for further eye care.  Another important aspect of this study is understanding human-computer interaction (HCI) and how new technologies can be successfully incorporated into existing clinical workflows.

“Diabetic retinopathy is the most common complication of diabetes and is the leading cause of vision loss in working-age people in the United States,” Dr. Garg said. “With timely screening and intervention, 90 percent of vision loss from diabetes can be prevented. Therefore, the international and national guidelines have been established that recommend all patients with diabetes should receive an annual retinal exam. However, due to a variety of barriers, less than half of all Americans with diabetes receive this important screening evaluation. Telemedicine and this new paradigm of retinal screening have the potential to overcome these barriers.”

One barrier is poor access to eye care providers, especially in rural areas of North Carolina.  In Dr. Garg’s previous work with diabetic retinopathy, she found that some parts of the state have diabetic screening rates as low as 3 percent.  Rates of vision loss in these communities are high, as a result. Dr. Garg and her team are trying to change this by essentially bringing the retinal screening to patients during their routine diabetes clinic visit. The barriers of transportation, family members needing to take time off due to the patient being dilated and unable to drive, additional specialist co-pays and insufficient education, are all overcome with a telemedicine solution.  This project could make a tremendous public health impact by increasing screening rates and ultimately, reducing rates of preventable blindness from diabetes. 

“This is great for patients,” said Tom Miller, MD, professor of medicine. “They have their exam completed in about ten minutes while they’re seeing their primary care doctor. We’re capturing people that probably wouldn’t get their eyes evaluated otherwise.”

In addition to testing new camera technology and developing a new workflow integrating technology and telemedicine, de-identified images are being collected – with patients’ consent – to train artificial intelligence (AI) algorithms which will ultimately automate the reading and diagnosis process.  Dr. Garg said her team in UNC Internal Medicine is offering screening to as many patients with diabetes as possible. The clinical trial will continue until 1,000 patients are evaluated and consented to the use of their images in the AI training. The researchers are nearly halfway to that goal.

The clinical trial is funded by Optos (Nikon) and is a collaboration amongst Optos, Verily (formerly Google Life Sciences) and the UNC School of Medicine.

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