Abstract

OBJECTIVE: Evaluate the validity and reproducibility of software for reading digital images and grading diabetic retinopathy.

RESEARCH DESIGN AND METHODS: A prospective, comparative observational study was conducted on a series of patients with type 2 diabetes mellitus who presented at the retina clinic of a tertiary care centre in India. Two hundred and ten eyes of 105 patients were allocated to one of three ophthalmologists, who performed dilated indirect and direct ophthalmoscopy, and subsequently assessed the digital images of the same group of patients being masked to the patient's identity. The inter-observer and inter-test agreement between clinical assessments and grading of diabetic retinopathy using the software was estimated.

RESULTS: Moderate non-proliferative diabetic retinopathy was most frequently diagnosed both clinically and on evaluating digital images. The overall agreement between the clinical grading of DR and the grading of images was 81.3% (Kappa 0.69, SE 0.04 p<0.0001); there was good agreement (81.3%) for NPDR (Kappa 0.61, SE 0.05 p<0.0001), but agreement was not as good (54.6%) for PDR (Kappa 0.29, SE 0.11 p0.005). CSME was diagnosed in 33.3% (70/210) eyes clinically, and in 40.2% (84/209) eyes by grading images, and there was good agreement (89.5%) between the two (Kappa 0.77, SE 0.07 p<0.0001).

CONCLUSIONS: ADRES 3.0 is a simple and valid tool to assist the detection of sight threatening retinopathy, and could supplement dilated fundus examinations by ophthalmologists on patients to detect diabetic retinopathy.