Detecting vision-threatening diabetic retinopathy with the RETeval-DR electroretinography/pupillography system
Speaker: Prof Quentin Davis
Diabetic retinopathy (DR) is a major cause of blindness worldwide, due in part to the challenge of detecting vision-threatening diabetic retinopathy (VTDR) in time for effective intervention. Contributing factors to low VTDR detection include patient characteristics (low compliance to the recommended annual dilated eye examination and patient aversion to eye dilation) and test method characteristics (significant failure rates and low sensitivity).
This presentation describes results from four clinical trials using the hand-held RETeval-DR device (Welch-Allyn, USA) for detecting VTDR. The RETeval-DR device measures an electroretinogram (ERG) and a pupillary response, both of which are well established to be affected by VTDR, and combines the information into a numerical value for VTDR detection. Four trials using five trial sites have tested 880 subjects (241 positive subjects) in the United States, United Kingdom, and Japan. Weighting the reported sensitivity / specificity from each trial by the number of subjects, the sensitivity and specificity for the detection of VTDR is 88% and 69% respectively. Testing time, in any patient setting, is under 5 minutes and is non-mydriatic, non-invasive, providing immediate objective results, which may improve testing compliance. Concluding, the RETeval-DR device may reduce blindness from diabetic retinopathy by improving the detection of VTDR.
Topic 1: Diabetic retinopathy
Topic 2: Clinical trial results for the detection of vision-threatening diabetic retinopathy
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