The scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA) study paper 2

Purpose To determine if the Eidon white light 60-degree field Scanning Confocal Ophthalmoscope (SCO) camera was safe to use with staged mydriasis in a Diabetic Eye Screening Programme (DESP). Methods The trial participants were recruited from people with diabetes attending appointments in DESP or Virtual Eye clinics for post-Covid delayed hospital appointments. Using staged mydriasis, the SCO images were taken before the pupils were dilated and compared to two-field 45 degrees mydriatic digital photography (the reference standard). Mydriatic SCO images were only compared to the reference standard if the non-mydriatic SCO images were unassessable. Results 1050 patients were recruited, 35 individuals were withdrawn, the majority (18) due to an imaging protocol deviation leaving 1015 individuals (2029 eyes). Using staged mydriasis, the sensitivity and specificity for any retinopathy was 97.5% (95% CI: 96.4–98.4%) and 82.3% (95% CI: 79.6–84.7%) respectively. The sensitivity and specificity for referable retinopathy was 92.7% (95% CI: 89.9–94.9%) and 85.4% (95% CI: 83.6–87.2%) respectively. The total number of eyes that were unassessable with the Eidon without mydriasis was 85/2029 (4.2%), and after mydriasis was 34/2029 (1.7%) and, with the reference standard, 34/2029 (1.7% - not always the same images) were unassessable. Conclusions This study provides promising early results of the performance of the Eidon camera using staged mydriasis in a DESP which needs further evidence from a non-Caucasian population and from cost-effectiveness analyses.