Comparison of 1-Field and 2-Field Mydriatic Handheld Retinal Imaging with Early Treatment Diabetic Retinopathy Study (ETDRS) 7-Standard Field Photography for Diabetic Retinopathy (DR) and diabetic macular edema (DME)

Abstract

Purpose : To determine agreement of 1-field (1F, macula centered) and 2-field (2F, disc/macula) mydriatic handheld retinal imaging with standard ETDRS photography for DR/DME.

Methods : Images from 177 eyes of 92 patients with diabetes were evaluated. By ETDRS photos: no DR 40.1% eyes, mild NPDR 19.2%, moderate 14.7%, severe 10.2%, proliferative DR 15.8%; no DME 72.9%, DME 6.8%, CSME 17.0%, ungradable 3.4%. Ungradable rate for DR and a summary of results are shown in Table 1. DME was ungradable in AU:10.2%, SS:13.0%, RV:5.7%. 2F imaging increased exact agreement of DR grading between handheld retinal imaging and ETDRS photos by 8.3% AU, 15.2% SS, 6.3% RV; agreement within 1-step was increased by 6.1% AU, 10.1% SS, 1.3% RV. 2F imaging with AU/SS increased K and K_W although it remained moderate. 2F imaging did not substantially increase sensitivity for any DR, refDR and vtDR across all devices.

Results : Images from 177 eyes of 92 patients with diabetes were evaluated. By ETDRS photos: no DR 40.1% eyes, mild NPDR 19.2%, moderate 14.7%, severe 10.2%, proliferative DR 15.8%; no DME 72.9%, DME 6.8%, CSME 17.0%, ungradable 3.4%. Ungradable rate for DR and a summary of the results is shown in table 1. DME was ungradable in AU:10.2%, SS:13.0%, RV:5.7%. 2F imaging increased exact agreement of DR grading between handheld retinal imaging and ETDRS photos by 8.3% AU, 15.2% SS, 6.3% RV; agreement within 1-step was increased by 6.1% AU, 10.1% SS, 1.3% RV. 2F imaging increased kappa agreement with ETDRS photos for DR by 11.3% AU and 15.6% SS. 2F imaging did not significantly increase sensitivity for any DR, refDR and vtDR across all devices.

Conclusions : Handheld 1F imaging with a field of view less than 60⁰ do not meet established standards for sensitivity (80%) and specificity (90%) in identifying DR and refDR. Ungradable rate was reduced by 36-50% and agreement with ETDRS was increased (6.3-15.2%) with the acquisition of a second field. The benefit of a second field decreased as the field of view of the device increased. For the tested instruments, a minimum handheld 1F 60⁰ or 2F imaging are needed to adequately determine referable DR in DR screening programs.

This is a 2021 ARVO Annual Meeting abstract.

 

Comparison of 1F, 2F and ETDRS 7-field photography

 

Agreement of 1F and 2F handheld imaging with ETDRS photography