Digital fundus image grading with the non-mydriatic Visucam(PRO NM) versus the FF450(plus) camera in diabetic retinopathy.

PURPOSE: Grading diabetic retinopathy in clinical trials is frequently based on 7-field stereo photography of the fundus in diagnostic mydriasis. In terms of image quality, the FF450(plus) camera (Carl Zeiss Meditec AG, Jena, Germany) defines a high-quality reference. The aim of the study was to investigate if the fully digital fundus camera Visucam(PRO NM) could serve as an alternative in clinical trials requiring 7-field stereo photography. METHODS: A total of 128 eyes of diabetes patients were enrolled in the randomized, controlled, prospective trial. Seven-field stereo photography was performed with the Visucam(PRO NM) and the FF450(plus) camera, in random order, both in diagnostic mydriasis. The resulting 256 image sets from the two camera systems were graded for retinopathy levels and image quality (on a scale of 1-5); both were anonymized and blinded to the image source. RESULTS: On FF450(plus) stereoscopic imaging, 20% of the patients had no or mild diabetic retinopathy (ETDRS level < or = 20) and 29% had no macular oedema. No patient had to be excluded as a result of image quality. Retinopathy level did not influence the quality of grading or of images. Excellent overall correspondence was obtained between the two fundus cameras regarding retinopathy levels (kappa 0.87) and macular oedema (kappa 0.80). In diagnostic mydriasis the image quality of the Visucam was graded slightly as better than that of the FF450(plus) (2.20 versus 2.41; p < 0.001), especially for pupils < 7 mm in mydriasis. CONCLUSIONS: The non-mydriatic Visucam(PRO NM) offers good image quality and is suitable as a more cost-efficient and easy-to-operate camera for applications and clinical trials requiring 7-field stereo photography.