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RETeval device a viable option for diabetic retinopathy screening
SAN FRANCISCO — The RETeval device may be a promising new screening tool for diabetic retinopathy due to its ease of use and low failure rates, according to late-breaking data presented at the American Diabetes Association’s 74th Scientific Sessions.
“These data are clinically relevant for ophthalmologists and endocrinologists for the treatment of diabetic retinopathy because the RETeval machine (LKC Technologies) is a new tool for screening patients with diabetes for eye disease that can be performed by the primary care physician,” April Y. Maa, MD, of the Atlanta VAMC/Emory Eye Center, told Ocular Surgery News. “It does not use photographs (ie, the device is not a camera), which traditionally have a failure rate of 10% to 15%, and instead measures and uses electrical signals generated by the eye (30Hz ERG), to determine level of retinopathy.”
Preliminary data indicated that the RETeval machine was easy to use, with no patient dilation or skin preparation required, and was user-friendly, requiring minimal training.
The most surprising finding, Maa said, was how quickly the test could be performed.
“According to our poster graph, it took only 2.3 minutes on average to perform the test in both eyes of a patient,” Maa said.
In their study, Maa and colleagues classified 500 patients with diabetes into one of five groups: those with no diabetic retinopathy with ETDRS level 10, those with mild diabetic retinopathy and ETDRS levels 14 to 35, those with moderate diabetic retinopathy without clinically significant macular edema (CSME) and ETDRS levels 43 to 47, those with mild-to-moderate diabetic retinopathy with CSME and ETDRS levels 10 to 47, those with severe diabetic retinopathy or proliferative diabetic retinopathy with ETDRS levels 53 and higher. Of the initial 500 patients, 392 completed the study.
After completion of the RETeval test, patients were dilated and ETDRS-compliant seven-field stereo fundus photographs were taken. The photographs were reviewed in a double-masked fashion in a reading center, according to data.
The RETeval device had a technical failure rate of 0.5% (n = 2) compared with a significantly higher failure rate of 15% (n = 57) using fundus photography (P < .001), according to Maa.
“Our preliminary data suggest the RETeval device is accurate in discerning levels of diabetic retinopathy, but we need further data analysis to confirm these data,” Maa said. The device is not U.S. Food and Drug Administration-approved yet, and we are in the process of completing our data analysis.” – by Samantha Costa
Disclosure: Maa has no relevant financial disclosures.
For more information:
Maa AY. Abstract #31-LB. Presented at: American Diabetes Association’s 74th Scientific Sessions; June 13-17, 2014; San Francisco.