Purpose To determine whether hard exudates (HE) within one disc diameter of the foveola is an acceptable criterion for the referral of diabetic patients suspected of clinically significant macular edema (CSME) in a screening setting. Methods 143 adults diagnosed with diabetes mellitus were imaged using a non-mydriatic digital fundus camera at the Alameda County Medical Center in Oakland, CA. Non-stereo fundus images were graded independently for the presence of HE near the center of the macula by two graders according to the EyePACS grading protocol. The patients also received a dilated fundus exam on a separate visit. CSME was determined during the dilated fundus examination using the criteria set forth by the Early Treatment Diabetic Retinopathy Study. Subsequently, the sensitivity and specificity of hard exudates within one disc diameter of the foveola in non-stereo digital images used as a surrogate for the detection of CSME diagnosed by live fundus examination were calculated. Results The mean age of 103 patients included in the analysis was 56±17years. CSME was diagnosed in 15.5% of eyes during the dilated exam. For the right eyes, the sensitivity of hard exudates within one disc diameter from the foveola as a surrogate for detecting CSME was 93.8% for each of the graders; the specificity was 88.5% and 85.1%. For the left eyes, the sensitivity was 93.8% and 75% for each of the two graders, respectively; the specificity was 87.4% for both graders. Conclusions This study supports the use of HE within a disk diameter of the center of the macula in non-stereo digital images for CSME detection in a screening setting.

Significance:The pathological changes in clinically significant diabetic macular edema lead to greater retinal thickening in males than in females. Therefore, male sex should be considered a potential risk factor for identifying individuals with the most severe pathological changes. Understanding this excessive retinal thickening in males may help preserve vision.Purpose: To investigate the sex differences in retinal thickness for diabetic patients. We tested whether males with clinically significant macular edema had even greater central macular thickness than expected from sex differences without significant pathological changes. To determine which retinal layers contribute to abnormal retinal thickness.Methods: From 2047 underserved adult diabetics from Alameda County, CA, 142 patients with clinically significant macular edema were identified by EyePACS certified graders using color fundus images (Canon CR6-45NM). First, central macular thickness from spectral domain optical coherence tomography (iVue, Optovue) was compared for 21 males vs. 21 females without clinically significant macular edema. Then, a planned comparison contrasted the greater values of central macular thickness for males vs. females with clinically significant macular edema, as compared to those without. Mean retinal thickness and variability of central macular layers were compared for males vs. females.Results: Males without clinically significant macular edema had a 12 μm greater central macular thickness than females, 245 ± 21.3 μm and 233 ± 13.4 μm, respectively, t(40) = −2.18, P = .04.Males with clinically significant macular edema had a 67 μm greater central macular thickness than females, 383 ± 48.7 μm and 316 ± 60.4 μm, P < .001, i.e. males had 55 μm or > 5x more, t(20) = 2.35, P = .015. In males, the outer nuclear layer thickness was more variable F 10,10 = 9.34. Conclusions:Underserved diabetic males had thicker retinas than females, exacerbated by clinically significant macular edema.

PurposeTo investigate whether cysts in diabetic macular edema are better visualized in the red channel of color fundus camera images, as compared with the green channel, because color fundus camera screening methods that emphasize short-wavelength light may miss cysts in patients with dark fundi or changes to outer blood retinal barrier.MethodsFundus images for diabetic retinopathy photoscreening were acquired for a study with Aeon Imaging, EyePACS, University of California Berkeley, and Indiana University. There were 2047 underserved, adult diabetic patients, of whom over 90% self-identified as a racial/ethnic identify other than non-Hispanic white. Color fundus images at nominally 45 degrees were acquired with a Canon Cr-DGi non-mydriatic camera (Tokyo, Japan) then graded by an EyePACS certified grader. From the 148 patients graded to have clinically significant macular edema by the presence of hard exudates in the central 1500 μm of the fovea, we evaluated macular cysts in 13 patients with cystoid macular edema. Age ranged from 33 to 68 years. Color fundus images were split into red, green, and blue channels with custom Matlab software (Mathworks, Natick, MA). The diameter of a cyst or confluent cysts was quantified in the red-channel and green-channel images separately.ResultsCyst identification gave complete agreement between red-channel images and the standard full-color images. This was not the case for green-channel images, which did not expose cysts visible with standard full-color images in five cases, who had dark fundi. Cysts appeared more numerous and covered a larger area in the red channel (733 ± 604 μm) than in the green channel (349 ± 433 μm, P < .006).ConclusionsCysts may be underdetected with the present fundus camera methods, particularly when short-wavelength light is emphasized or in patients with dark fundi. Longer wavelength techniques may improve the detection of cysts and provide more information concerning the early stages of diabetic macular edema or the outer blood retinal barrier.

IMPORTANCE Diabetic macular edema is one of the leading causes of vision loss among working-age adults in the United States. Telemedicine screening programs and epidemiological studies rely on monoscopic fundus photography for the detection of clinically significant macular edema (CSME). Improving the accuracy of detecting CSME from monoscopic images could be valuable while recognizing the limitations of such detection in an era of optical coherence tomography detection of diabetic macular edema.OBJECTIVE To evaluate the screening test accuracy of radially arranged sectors affected by hard exudates in the detection of CSME.DESIGN, SETTING, AND PARTICIPANTS This investigation was a cross-sectional study of CSME grading in monoscopic images using a sectors approach. The Early Treatment Diabetic Retinopathy Study criteria were used to confirm the presence of CSME by the following 2 methods: stereoscopic fundus photography (method 1) and dilated biomicroscopy in combination with optical coherence tomography (method 2). Participants were recruited at a university-based practice between June 14, 2014, and December 28, 2015. MAIN OUTCOMES AND MEASURESArea under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and negative predictive value.RESULTS A total of 207 eyes from an ethnically/racially diverse group of 207 patients (mean [SD] age, 53.6 [10.8] years; 58.9% [122 of 207] female) were included in the analysis. Twelve eyes (5.8%) were diagnosed as having CSME based on method 1. The intermethod and intergrader agreement for CSME diagnosis and sector count was substantial (κ range, 0.66 [95% CI, 0.47-0.85] to 0.75 [95% CI, 0.53-0.97]; P < .001 for all). Area under the receiver operating characteristic curve was 93.2% (95% CI, 84.2%-100%) when evaluating a sectors approach against method 1 as a reference test and offered up to an 8.6% (95% CI, 3.0%-14.3%) increase in specificity compared with the existing methods of detection. The positive predictive value was 33.3% (95% CI, 25.6%-45.5%), and the negative predictive value was 98.1% (95% CI, 96.9%-100%). The results were similar when comparing a sectors approach with method 2 as a reference test. CONCLUSIONS AND RELEVANCEA sectors approach shows good screening test characteristics for the detection of CSME. Its implementation in the existing telemedicine programs would require minimal resources. This approach will have the greatest effect in a setting where implementation of optical coherence tomography, a more objective and sensitive way to detect retinal thickening, is not feasible. The proposed method also may be easily incorporated in the automated diabetic retinopathy detection algorithms.

We have proposed OCT-based classification of DME into severe and nonsevere CSME. Based on this limited analysis, severity of CSME is related more to extent of HE rather than proximity to the center of the macula.