Clinically significant macular edema in an underserved population: Association with demographic factors and hemoglobin A1c.

SIGNIFICANCE: Suspected clinically significant macular edema (SCSME) from exudates differed among ethnic groups in our underserved population. African American and Asian subjects had higher prevalence than Hispanics and non-Hispanic Caucasians, from the same clinics. Men had higher prevalence than women. Highly elevated blood glucose was frequent and associated with SCSME. PURPOSE: We investigated the association between the presence of SCSME from exudates and hemoglobin A1c (HbA1c), as well as demographic factors such as age, sex, and ethnic group. Our population was underserved diabetic patients from the same geographic locations. Ethnic groups were White Hispanic, non-Hispanic Caucasian, African American, and Asian, with a high proportion of underrepresented minorities. METHODS: In a diabetic retinopathy screening study at four community clinics in Alameda County, California, nonmydriatic 45° color fundus images were collected from underserved diabetic subjects following the EyePACS imaging protocol. Images were analyzed for SCSME from exudates by two certified graders. Logistic regression assessed the association between SCSME from exudates and age, sex, ethnic group, and HbA1c. RESULTS: Of 1997 subjects, 147 (7.36%) had SCSME from exudates. The mean ± standard deviation age was 53.4 ± 10.5 years. The mean ± standard deviation HbA1c level was 8.26 ± 2.04. Logistic regression analysis indicated a significant association between presence of SCSME from exudates and HbA1c levels (p<0.001), sex (p=0.027), and ethnicity (p=0.030). African Americans (odds ratio [OR], 1.63; 95% confidence interval [CI], 1.06 to 2.50; p=0.025) and Asians (OR, 1.63; 95% CI, 1.05 to 2.54; p=0.029) had a higher risk than Hispanics. After adjusting for ethnicity, sex, and age, the odds of developing SCSME from exudates increased by 26.5% with every 1% increase in HbA1c level (OR, 1.26; 95% CI, 1.18 to 1.36; p<0.001). CONCLUSIONS: In our underserved population, many diabetic patients had very high HbA1c values. Ethnic background (African American > Asians > Hispanics), sex (male > female), and HbA1c level were strong indicators for identifying who is at increased risk of developing SCSME from exudates.

Adherence to ophthalmology referral, treatment and follow-up after diabetic retinopathy screening in the primary care setting.

INTRODUCTION: Telemedicine-based diabetic retinopathy screening (DRS) in primary care settings has increased the screening rates of patients with diabetes. However, blindness from vision-threatening diabetic retinopathy (VTDR) is a persistent problem. This study examined the extent of patients' adherence to postscreening recommendations. RESEARCH DESIGN/METHODS: A retrospective record review was conducted in primary care clinics of a large county hospital in the USA. All patients with diabetes detected with VTDR in two time periods, differing in record type used, were included in the study: 2012-2014, paper charts only; 2015-2017, combined paper charts/electronic medical records (EMRs), or EMRs only. Adherence rates for keeping initial ophthalmology appointments, starting recommended treatments, and keeping follow-up appointments were determined. RESULTS: Adequate records were available for 6046 patients; 408 (7%) were detected with VTDR and recommended for referral to ophthalmology. Only 5% completed a first ophthalmology appointment within recommended referral interval, 15% within twice the recommended interval, and 51% within 1 year of DRS. Patients screened in 2015-2017 were more likely to complete a first ophthalmology appointment than those in 2012-2014. Ophthalmic treatment was recommended in half of the patients, of whom 94% initiated treatment. A smaller percentage (41%) adhered completely to post-treatment follow-up. Overall, 28% of referred patients: (1) kept a first ophthalmology appointment; (2) were recommended for treatment; and (3) initiated the treatment. Most patients failing to keep first ophthalmology appointments continued non-ophthalmic medical care at the institution. EMRs provided more complete information than paper charts. CONCLUSIONS: Reducing vision impairment from VTDR requires greater emphasis on timely adherence to ophthalmology referral and follow-up. Prevention of visual loss from VTDR starts with retinopathy screening, but must include patient engagement, adherence monitoring, and streamlining ophthalmic referral and management. Revision of these processes has already been implemented at the study site, incorporating lessons from this investigation.

Central Macular Thickness in Diabetic Patients: A Sex-based Analysis.

SIGNIFICANCE: The pathological changes in clinically significant diabetic macular edema lead to greater retinal thickening in men than in women. 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 men may help preserve vision. PURPOSE: The purpose of this study was to investigate the sex differences in retinal thickness in diabetic patients. We tested whether men with clinically significant macular edema had even greater central macular thickness than expected from sex differences without significant pathological changes. This study also aimed to determine which retinal layers contribute to abnormal retinal thickness. METHODS: From 2047 underserved adult diabetic patients 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 Inc.) was compared in 21 men versus 21 women without clinically significant macular edema. Then, a planned comparison contrasted the greater values of central macular thickness in men versus women with clinically significant macular edema as compared with those without. Mean retinal thickness and variability of central macular layers were compared in men versus women. RESULTS: Men without clinically significant macular edema had a 12-µm greater central macular thickness than did women (245 ± 21.3 and 233 ± 13.4 µm, respectively; t40 = -2.18, P = .04). Men with clinically significant macular edema had a 67-µm greater central macular thickness than did women (383 ± 48.7 and 316 ± 60.4 µm, P < .001); that is, men had 55 µm or more than five times more (t20 = 2.35, P = .02). In men, the outer-nuclear-layer thickness was more variable, F10,10 = 9.34. CONCLUSIONS: Underserved diabetic men had thicker retinas than did women, exacerbated by clinically significant macular edema.

A Revised Approach for the Detection of Sight-Threatening Diabetic Macular Edema.

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 MEASURES: Area 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 RELEVANCE: A 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.

Comparison of Cysts in Red and Green Images for Diabetic Macular Edema.

PURPOSE: To 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. METHODS: Fundus 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. RESULTS: Cyst 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). CONCLUSIONS: Cysts 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.

Improving Accuracy of Grading and Referral of Diabetic Macular Edema Using Location and Extent of Hard Exudates in Retinal Photography.

BACKGROUND: Hard exudates (HE) are used as a surrogate marker for sight-threatening diabetic macular edema (DME) in most telemedicine-based screening programs in the world. This study investigates whether proximity of HE to the center of the macula, and extent of HE are associated with greater clinically significant macular edema (CSME) severity. A novel method for associating optical coherence tomography (OCT) scans with CSME was developed. METHODS: Eligible subjects were recruited from a DRS program in a community clinic in Oakland, California. Ocular fundus of each subject was imaged using 3-field 45-degree digital retinal photography and scanned using central 7-line spectral domain OCT. Two certified graders separated subjects into 2 groups, those with and without HE within 500 microns from the center of the macula. A modified DME severity scale, developed from Early Treatment Diabetic Retinopathy Study data and adapted to OCT thickness measurements, was used to stratify CSME into severe and nonsevere levels for all subjects. RESULTS: The probabilities of severe CSME in groups 1 and 2 were 14.4% (95% CI: 8.2%-23.8%) and 9% (95% CI: 2.4%-25.5%), respectively (P = .556). In post hoc analysis, increase in the number of sectors affected by HE within the central zone of the macula was associated with the increase in the probability of being diagnosed with severe CSME. CONCLUSION: 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.

Utility of hard exudates for the screening of macular edema.

PURPOSE: The purpose of this study was to determine whether hard exudates (HEs) 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: One hundred forty-three adults diagnosed as having diabetes mellitus were imaged using a nonmydriatic digital fundus camera at the Alameda County Medical Center in Oakland, CA. Nonstereo 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 examination on a separate visit. Clinically significant macular edema 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 HEs within one disc diameter of the foveola in nonstereo digital images used as a surrogate for the detection of CSME diagnosed by live fundus examination were calculated. RESULTS: The mean (±SD) age of 103 patients included in the analysis was 56 ± 17 years. Clinically significant macular edema was diagnosed in 15.5% of eyes during the dilated examination. For the right eyes, the sensitivity of HEs within one disc diameter from the foveola as a surrogate for detecting CSME was 93.8% for each of the graders; the specificity values were 88.5 and 85.1%. For the left eyes, the sensitivity values were 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 disc diameter of the center of the macula in nonstereo digital images for CSME detection in a screening setting.