Aiello, Lloyd Paul

Alog, Glenn

Aquino, Lizzie Anne

Elmasry, Mohamed Ashraf

Jacoba, Cris Martin

Peto, Tunde

Rageh, Abdulrahman

Salongcay, Recivall Pascual

Salva, Claude Michael

Silva, Paolo S

Sun, Jennifer K

Viguilla Saunar, Aileen

Purpose : To compare nonmydriatic handheld retinal imaging with ETDRS standard 7-field 300 fundus photographs (ETDRS photos) for assessment of DR and DME severity.Methods : Following a standard imaging protocol, nonmydriatic retinal images were taken using handheld retinal cameras [Aurora(AU), Smartscope(SS), RV700(RV)] and compared to dilated ETDRS photos. Images were evaluated at a centralized reading center by 4 independent graders (2 certified graders, 1 ophthalmologist, 1 retina specialist) using the International DR/DME classification. A senior retina specialist adjudicated all differences. Kappa statistics [simple (K),weighted (KW)] assessed agreement for DR/DME. Sensitivity and specificity for any DR, referable DR [(refDR) moderate nonproliferative DR (NPDR) or worse, any DME or ungradable images] and vision threatening DR [(vtDR) severe NPDR or worse, clinically significant DME (CSME) or ungradable images] were calculated.Results : Images from 177 eyes of 92 patients with diabetes were evaluated. Severity by ETDRS photos, DR: no DR 40.1% eyes, mild NPDR 19.2%, moderate 14.7%, severe 10.2%, and proliferative DR 15.8%; DME: No DME 72.9%, DME 6.8%, ciDME 17.0%, 3.4% ungradable. Ungradable rate for DR/DME for AU: 13.0%/15.8%; SS: 15.3%/18.1% and RV: 35.6%/36.7%. Agreement of clinical DR grading between handheld retinal and ETDRS photos are shown in table 1. Among the devices, AU (exact 58.8%; w/in 1-step 83.1%) had the highest agreement with ETDRS photos. These are higher than SS (56.5%; 80.2%) and RV (47.5%; 62.7%). Ungradable images were associated with a higher rate of refDR on corresponding ETDRS photos (AU 4.8x, SS 2.9x, RV 2.1x, p&lt;0.0001). Table 1 shows the sensitivity/specificity for any DR, refDR and vtDR. AU, SS and RV had 71-97% specificity and 82-96% sensitivity for any DR, refDR and vtDR.Conclusions : Despite a standardized protocol of image capture and evaluation, the ungradable rate of these devices varies from 13%-36%. In this cohort, there was a 2.1 to 4.8-fold increased risk of refDR among ungradable images. Thus, although handheld nonmydriatic retinal devices are able to achieve substantial agreement with DR in some cases, additional methods may be needed to reduce ungradable rates and appropriately triage eyes that require specialized care.<br/

Salva, Claude

Alog, Glenn P.

Sun, Jennifer K.

Silva, Paolo S.

Queen's University Belfast Research Portal

Comparison of nonmydriatic handheld retinal imaging with early treatment diabetic retinopathy study (ETDRS) 7-standard field photography for diabetic retinopathy (DR) and diabetic macular edema (DME)

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 KW 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 program

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)

Purpose : To compare mydriatic handheld retinal imaging with standard ETDRS 7-field color 30-degree fundus photography (ETDRS photos) for assessment of DR/DMEMethods : Following standard imaging protocol, mydriatic retinal images were acquired using handheld retinal cameras [Aurora (AU), Smartscope (SS), RV700 (RV) and InView (NV)] and dilated ETDRS photos (Figure 1). All images were evaluated at a centralized reading center independently by 4 graders (2 certified retinal image/graders, 1 ophthalmologist, 1 retina specialist). All differences were adjudicated by a senior retina specialist. Kappa statistics [simple (K), weighted (KW)] assessed agreement for DR/ DME. Sensitivity/specificity for any DR, referable DR [(refDR) moderate nonproliferative DR (NPDR) or worse, any DME or ungradable images] and vision threatening DR [(vtDR) severe NPDR or worse, clinically significant DME (CSME) or ungradable images] were calculated.Results : Images from 177 eyes of 92 patients with diabetes were evaluated. Severity by ETDRS photos: no DR 40.1%, mild NPDR 19.2%, moderate 14.7%, severe in 10.2%, proliferative DR 15.8%; no DME 72.9%, DME 6.8%, ciDME 17.0%; ungradable 3.4%. Ungradable rate for DR/DME for AU: 0%/0.56%; SS: 4.5%/5.7%; RV:4.0%/5.7%; and NV:7.3%/35.6%. Kappa statistics and agreement rates with ETDRS photos for DR/DME are shown in Table 1. Agreement with DR was highest with the AU (Kw=0.79) and lowest with NV (Kw=0.53). DME agreement was similar across all devices (Kw = 0.79-0.83). Agreement for DR severity with ETDRS photos was highest with AU (68.9% exact, 96.6% 1-step). Sensitivity/Specificity for any DR, refDR and vtDR are shown in Table 1. The established standards (0.80 sensitivity,0.95 specificity) were met by AU, SS and RV for any DR and refDR.Conclusions : Following a standardized protocol, handheld retinal imaging devices have substantial levels of agreement for DR/DME and meet accepted standards for sensitivity and specificity in identifying any DR and refDR. However, the ungradable rate varies greatly, exceeding 35% even with pupil dilation in some devices. None of the handheld devices met the established 95% specificity for vtDR

Garcia Silva, Claude Michael

Alog, Glenn P

Comparison of mydriatic handheld retinal imaging with early treatment diabetic retinopathy study (ETDRS) 7-standard field photography for diabetic retinopathy (DR) and diabetic macular edema (DME)

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)

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)

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