Single-site, prospective, comparative, instrument validation study.
One hundred three diabetic patients (206 eyes) representing the full spectrum of DR severity underwent nonmydriatic ultrawide field 100-degree and 200-degree imaging, dilated ETDRS photography, and dilated fundus examination by a retina specialist. Two independent readers graded images to determine DR and DME severity. A third masked retina specialist adjudicated discrepancies.
Based on ETDRS photography (n = 200), the results were as follows: no DR (n = 25 eyes [12.5 % ]), mild nonproliferative DR (NPDR; 47 [23.5 % ]), moderate NPDR (61 [30.5 % ]), severe NPDR (11 [5.5 % ]), very severe NPDR (3 [1.5 % ]), and proliferative DR (52 [2.5 % ]). One (0.5 % ) eye was ungradable and 6 eyes did not complete ETDRS photography. No DME was found in 114 eyes (57.0 % ), DME was found in 28 eyes (14.0 % ), and clinically significant DME was found in 47 eyes (23.5 % ), and 11 (5.5 % ) eyes were ungradable. Exact DR severity agreement between ultrawide field 100-degree imaging and ETDRS photography occurred in 84 % , with agreement within 1 level in 91 % (KW = 0.85; K = 0.79). Nonmydriatic ultrawide field images exactly matched clinical examination results for DR in 70 % and were within 1 level in 93 % (KW = 0.71; K = 0.61). Nonmydriatic ultrawide field imaging acquisition time was less than half that of dilated ETDRS photography (P < .0001).
Nonmydriatic ultrawide field images compare favorably with dilated ETDRS photography and dilated fundus examination in determining DR and DME severity; however, they are acquired more rapidly. If confirmed in broader diabetic populations, nonmydriatic ultrawide field imaging may prove to be beneficial in DR evaluation in research and clinical settings.