Pivotal trial to evaluate an Artificial intelligence (AI) diabetic retinopathy grading classifier in the New Zealand population undergoing regular screening for diabetic retinopathy.

Currently, when patients attend for their routine diabetic retinopathy screening visit, a photograph is taken of their retina. This is typically a 20-30 minute appointment. Once the image has been obtained all the images thus collected are sent to a human grading team for review and grading. (The conventional grading pathway). This usually happens several days after the patient has attended for screening with the final result being issued to the patient and their GP a couple of weeks later. During this current study the retinal images from those patients who give their consent, will also be read by an artificial intelligence classifier which has been trained to grade to the New Zealand MoH standard. (AI grading pathway). The inference of the AI classifier will be generated once the patient has left the clinic and thus it is envisaged that they will not be inconvenienced, or their clinic visit prolonged, if they choose to participate in this trial. A masked observer will then collect the grades issued to each patient after these images have passed through the conventional grading pathway and compare them against the grades issued to each patient after the images have passed through the AI grading pathway. At the time their consent is sought, patients will also be asked to complete a short questionnaire on their perceptions of artificial intelligence systems reading their retinal images. This questionnaire will be collected up by the team at the reception desk when they leave the clinic