New Study Confirms the Equivalence of optomap to ETDRS Gold Standard for Grading Diabetic Retinopathy

November is Diabetes Awareness Month.  In 2015, 30.3 million Americans, or 9.4% of the population, had diabetes and approximately 1.25 million American children and adults had type 1 diabetes. These numbers are on the rise and the disease manifests with deleterious and deadly impact throughout the body – including the eye. An understanding of the disease, early detection and treatment are more imperative than ever.

 

A recent study cooperatively funded by the National Eye Institute, the National Institute of Diabetes and Digestive and Kidney diseases and the US Department of Health and Human Services concluded  that optomap ultra-widefield (UWF™) retinal imaging is a useful diagnostic tool for detection and assessment of severity of diabetic retinopathy (DR). The study published recently in JAMA Ophthalmology demonstrates that optomap UWF imaging can be used reliably in place of Early Treatment Diabetic Retinopathy Study (ETDRS) 7-Field imaging in clinical use and future clinical trials.  The paper, which builds off recent single site studies that found moderate to perfect agreement between the modalities, supports these findings through data acquired over a two-year period from multiple sites.

The gold standard assessment of DR severity has been based on grading of lesions within the ETDRS 7 standard fields. These 7 fields are time consuming in their acquisition, require dilation and once compiled represent only 34% of the retinal surface.  Advances in retinal imaging technology now allow UWF imaging to capture 82% of the retina in a single image and in less than ½ second without the need for dilation. This collaborative study offers that given the technological advances now enabling UWF imaging, and the potential benefits of this approach, there may be substantial impetus for moving to UWF imaging if it is compatible in determining DR severity, and if pathology in the retinal periphery provides additional clinically useful information on prospective worsening of retinopathy.

In this current multi-site study, there were 737 gradable eyes on both ETDRS 7-field images and UWF images masked to contain the same 7 fields after adjudication; 59% had exact agreement, and 96% were within 1 step of agreement.  The conclusion of the study clearly supported moderate to perfect agreement between modalities within the limited masked scope of the current gold standard.  As seen was seen in previous studies, when the area outside of ETDRS was assessed predominantly peripheral DR lesions (PPL) were present in 41.0% of these eyes and suggested increased DR severity  by 2 or more steps in 11.0%.

Cursorily referenced in this preliminary paper was a consideration of efficiency between modalities.  This initial study release notes that the use of UWF imaging in clinical settings not only increases the frequency of DR identification nearly 2-fold but also reduces acquisition time by more than half, ungradable image rate by 71% and image evaluation by 28% compared with non-mydriatic fundus photography.

The study suggests the possibility of UWF imaging becoming a preferred method of assessment of DR severity, not only because of moderate to perfect agreement between modalities within the ETDRS scope, but also because of the information found in UWF outside the ETDRS mask. This raises the question regarding the potential for detecting DR change and severity earlier.  Data collected from a previous study, suggests that lesions observed outside of the area captured within ETDRS may identify a possible subset of patients with the disease that may be more aggressive.  These lesions were found to suggest a 4.7 times greater risk of worsening to treatable DR over a period of four years.  That study also concludes that the identification of a subset of patients at greatly increased risk of experiencing DR progression and onset of proliferative DR that cannot be assessed by ETDRS 7-field imaging, would have important implications for the evaluation and care of diabetic eye disease.

The significance of the additional peripheral information gleaned through UWF imaging in assessing the risk of future DR progression will develop with the data collected from this ongoing study.  The complete study and summary document, as well as our entire clinical library is available on our website. We encourage you to learn more about the clinical benefits of utilizing ultra-widefield optomap in your practice or clinic.

Sources:
Comparison of Early Treatment Diabetic Retinopathy Study Standard 7-Field Imaging with Ultra Widefield Imaging for Determining Severity of Diabetic Retinopathy. Journal of American Medicine, 2018
Peripheral Lesions Identified on Ultra Widefield Imaging Predict Increased Risk of Diabetic Retinopathy Progression Over Four Years. Ophthalmology 2015

optomap Aids Eyecare Professionals in Early Detection, Monitoring and Management of Diabetic Eye Disease

November is recognized as American Diabetes Month and Diabetic Eye Disease Awareness Month.  Diabetic Eye Disease Awareness Month aims to increase awareness of diabetes and diabetic eye disease and encourage people with diabetes to seek treatment for related vision problems.   According to Prevent Blindness America, Diabetes is now the leading cause of new cases of blindness in adults, and all people with diabetes are at risk for vision loss and blindness.

Diabetic eye disease refers to a group of eye problems that diabetic persons may face as a complication of this disease including:
Diabetic retinopathy
– A leading cause of blindness in American adults, it is caused by damage to the small blood vessels of the retina – the seeing layer of the eye.
Diabetic macular edema (DME)
 – A complication of diabetes caused by leaking blood vessels, which leads to fluid accumulation in the macula, the center of the retina used for central vision. DME can cause central vision to become blurry.
Cataract
– The clouding of the lens in the eye, which blocks or changes the passage of light into the eye. Cataracts can cause vision to become blurry.
Glaucoma
 – Optic nerve damage and possible loss of side vision, usually caused by increase in fluid pressure inside the eye.

Today, 3.6 million Americans age 40 and older suffer from Diabetic Retinopathy (DR), DR in its early stages has no symptoms as it begins to damage the small blood vessels in the retina, causing them to leak fluid and blood. As the disease progresses, blood vessels become blocked and they may rupture, or new vessels will grow on the retina, leading to vision loss. Treatments are available to help prevent and manage long term effects of the disease but are most effective when detected early.

 

David Brown, MD on UWF retinal imaging and its aid to advance the detection and management of diabetic retinopathy

Eyecare professionals can greatly enhance their ability to provide early detection of diabetic retinopathy with the use of ultra-widefield (UWF™) optomap technology.  optomap is specifically designed to provide an UWF image of the retina, and it is the only technology that captures 200-degrees of the retina a single capture and in less than ½ second. Because optomap images so far out in the periphery, where the damage from diabetic retinopathy often begins, it allows a clear look at the health of the retina in order to determine if there are any early warning signs of diabetic retinopathy. optomap can also be used to confirm a diagnosis, allowing eyecare professionals to initiate a plan of care as soon as possible.

In preventing vision loss in people with diabetes, primary interventions include regular, effective screenings to detect diabetic eye disease earlier combined with education to encourage patients to undergo yearly comprehensive eye examinations. Many clinicians agree that UWF is an important part of these examinations, this was discussed in an article by Dr. Paul Tornambe where he calls for the integration UWF imaging as both a practical and clinical asset to the management of patients with diabetes.  UWF continues to evolve to address specific patient requirements, including looking at non-mydriatic imaging alternatives which are also designed to be more time efficient. optomap is clinically proven as a leader in imaging patients with diabetes to support the detection of diabetic retinopathy and related diseases.

Visit our website to learn more about the clinical benefits of utilizing ultra-widefield optomap in your practice or clinic.

 

Sources:
https://www.friendsforsight.org/resources/eye-health-awareness/item/16-diabetic-eye-disease-month-november
https://nei.nih.gov/health/diabetic
https://www.visionaware.org/blog/visionaware-blog/november-is-diabetic-eye-disease-awareness-month-learn-more-about-diabetes-and-your-eyes/12
Paul E. Tornambe, MD, FACS. Cover Story – Ultra-Widefield Imaging: Advancing the Understanding and Management of Diabetic Retinopathy. Retina Today, April 2015 http://retinatoday.com/2015/04/ultra-widefield-imaging-advancing-the-understanding-and-management-of-diabetic-retinopathy