Disparities Between Teleretinal Imaging Findings and Patient-Reported Diabetic Retinopathy Status and Follow-up Eye Care Interval: A 10-Year Prospective Study.

OBJECTIVE: To assess self-reported awareness of diabetic retinopathy (DR) and concordance of eye examination follow-up compared with findings from concurrent retinal images. RESEARCH DESIGN AND METHODS: We conducted a prospective observational 10-year study of 26,876 consecutive patients with diabetes who underwent retinal imaging during an endocrinology visit. Awareness and concordance were evaluated using questionnaires and retinal imaging. RESULTS: Awareness information and gradable images were available in 25,360 patients (94.3%). Severity of DR by imaging was as follows: no DR (n = 14,317; 56.5%), mild DR (n = 6,805; 26.8%), or vision-threatening DR (vtDR; n = 4,238; 16.7%). In the no, mild, and vtDR groups, 96.7%, 88.5%, and 54.9% of patients, respectively, reported being unaware of any prior DR. When DR was present, reporting no prior DR was associated with shorter diabetes duration, milder DR, last eye examination >1 year before, no dilation, no scheduled appointment, and less specialized provider (all P < 0.001). Among patients with vtDR, 41.2%, 58.1%, and 64.2% did not report being aware of any DR and follow-up was concordant with current DR severity in 66.7%, 41.3%, and 25.4% (P < 0.001) of patients when prior examination was performed by a retinal specialist, nonretinal ophthalmologist, or optometrist (P < 0.001), respectively. CONCLUSIONS: Substantial discrepancies exist between DR presence, patient awareness, and concordance of follow-up across all DR severity levels. These discrepancies are present across all eye care provider types, with the magnitude influenced by provider type. Therefore, patient self-report should not be relied upon to reflect DR status. Modification of medical care and education models may be necessary to enhance retention of ophthalmic knowledge in patients with diabetes and ensure accurate communication between all health care providers.

Diabetic Retinopathy Severity and Peripheral Lesions Are Associated with Nonperfusion on Ultrawide Field Angiography.

PURPOSE: To assess whether the presence of peripheral nonperfusion on ultrawide field (UWF) fluorescein angiography (FA) is associated with diabetic retinopathy (DR) severity and the presence of predominantly peripheral lesions (PPLs). DESIGN: Single-site, cross-sectional, retrospective study. PARTICIPANTS: Sixty-eight eyes of 37 diabetic subjects with or without DR and no history of prior panretinal laser photocoagulation. METHODS: Both 200° UWF images and UWF FA images were acquired at the same visit. Early Treatment Diabetic Retinopathy Study (ETDRS) templates were overlaid digitally based on disc and macula location onto stereographically projected UWF images. Images were evaluated for the presence of PPLs, defined as more than 50% of the graded lesion located outside the ETDRS field in each of the 5 extended fields. The UWF-FA images were evaluated by 2 masked, independent graders for extent of retinal nonperfusion area (NPA) and nonperfusion index (NPI; nonperfused/total gradable area). MAIN OUTCOME MEASURES: Association of NPA and NPI with DR severity and presence of PPLs. RESULTS: Distribution of DR severity was as follows: no DR, 8.8% eyes; mild nonproliferative DR (NPDR), 17.6%; moderate NPDR, 32.4%; severe NPDR, 17.6%; proliferative DR (PDR), 19.1%; and high-risk PDR, 4.4%; with PPL present in 61.8%. There was strong intragrader (r = 0.95) and intergrader (r = 0.86) agreement for NPA. Presence of PPLs was associated with increased NPA (191.8 mm(2) vs. 306.1 mm(2); P = 0.0019) and NPI (0.25 vs. 0.43; P = 0.0003). These relationships remained significant after adjusting for DR severity and diabetes duration. In eyes without PDR (n = 52), increasing NPA and NPI was associated with worsening DR (NPA, P = 0.001; NPI, P = 0.0003). NPA and NPI were not associated with clinically significant macular edema (NPA, P = 0.99; NPI, P = 0.67), nor correlated with visual acuity (NPA, r = 0.14, P = 0.23; NPI, r = 0.24, P = 0.05). CONCLUSIONS: Following a standardized protocol, the evaluation of UWF FA for NPA and NPI is reproducible. Both parameters are correlated highly with the presence of PPLs and DR severity. Given that the presence and extent of PPLs have been associated with increased risks of DR progression, the clinical identification of PPLs may reflect closely the extent of nonperfusion and ischemia, thus accounting for the increased risk of progression.

Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years.

OBJECTIVE: To determine whether peripheral diabetic retinopathy (DR) lesions identified on ultrawide field (UWF) imaging are associated with increased DR progression. DESIGN: Prospective, longitudinal cohort. PARTICIPANTS: Two hundred eyes of 100 participants previously enrolled in a comparative instrument validation study. METHODS: Baseline mydriatic 7-standard field Early Treatment Diabetic Retinopathy Study (ETDRS) photographs and UWF images were obtained. On UWF images, DR lesions with a greater extent outside versus inside standard ETDRS fields were defined as predominantly peripheral lesions (PPLs). Follow-up ETDRS photographs were obtained 4.2±0.3 years after baseline. Baseline and follow-up DR severity were graded from ETDRS photographs. MAIN OUTCOME MEASURES: Rates of 2-step or more progression and progression to proliferative DR (PDR) in eyes with PPLs compared with eyes without PPLs identified on UWF imaging at baseline. RESULTS: In eyes without PDR (n = 109) at baseline, 56 (51%) had at least 1 field with PPLs and 43 (39%) had DR progression. Compared with eyes without PPLs, eyes with PPLs had a 3.2-fold increased risk of 2-step or more DR progression (6 [11%] vs. 19 [34%]; P = 0.005) and a 4.7-fold increased risk for progression to PDR (3 [6%] vs. 14 [25%]; P = 0.005). These findings remained statistically significant after adjusting for gender, diabetes type, diabetes duration, hemoglobin A1c (HbA1c) levels, and baseline DR severity. Increasing extent of fields with PPLs increased the risk for 2-step or more DR progression (P = 0.004) and progression to PDR (P = 0.009). CONCLUSIONS: Presence and increasing extent of PPLs were associated with increased risk of DR progression over 4 years, independent of baseline DR severity and HbA1c levels. Increasing extent of PPLs substantially increased the risk of DR progression and progression to PDR, especially with less severe DR at baseline. These findings demonstrate that detailed peripheral retinal evaluation provides important information that is necessary to assess completely the risk of DR progression.

Potential efficiency benefits of nonmydriatic ultrawide field retinal imaging in an ocular telehealth diabetic retinopathy program.

OBJECTIVE To compare efficiency of nonmydriatic ultrawide field retinal imaging (UWFI) and nonmydriatic fundus photography (NMFP) in a diabetic retinopathy (DR) ocular telehealth program. RESEARCH DESIGN AND METHODS Patients in this retrospective, comparative cohort study underwent NMFP and UWFI between 1 November 2011 and 1 November 2012. Images were evaluated for DR and diabetic macular edema (DME) by certified graders using a standard protocol at a centralized reading center. Identification of DR, image evaluation time, and rate of ungradable eyes were compared. RESULTS NMFP and UWFI were performed in 1,633 and 2,170 consecutive patients, respectively. No statistically significant differences were found between groups regarding age, diabetes duration, sex, ethnicity, or insulin use. The ungradable rate per patient for DR (2.9 vs. 9.9%, P < 0.0001) and DME (3.8 vs. 8.8%, P < 0.0001) was lower with UWFI than with NMFP. With UWFI, the median image evaluation time per patient was reduced from 12.8 to 9.2 min (P < 0.0001). The identification of patients with DR (38.4 vs. 33.8%) and vision-threatening DR (14.5 vs. 11.9%) was increased with UWFI versus NMFP. In a consecutive subgroup of 502 eyes of 301 patients with DR, the distribution of peripheral retinal lesions outside Early Treatment Diabetic Retinopathy Study fields suggested a more severe DR level in 9.0% (45 eyes). CONCLUSIONS In a standardized DR ocular telehealth program, nonmydriatic UWFI reduced the ungradable rate by 71% (to <3%) and reduced image evaluation time by 28%. DR was identified 17% more frequently after UWFI, and DR peripheral lesions suggested a more severe DR level in 9%. These data suggest that UWFI may improve efficiency of ocular telehealth programs evaluating DR and DME.

Peripheral lesions identified by mydriatic ultrawide field imaging: distribution and potential impact on diabetic retinopathy severity.

OBJECTIVE: To assess diabetic retinopathy (DR) as determined by lesions identified using mydriatic ultrawide field imaging (DiSLO200; Optos plc, Scotland, UK) compared with Early Treatment Diabetic Retinopathy Study (ETDRS) 7-standard field film photography. DESIGN: Prospective comparative study of DiSLO200, ETDRS 7-standard field film photographs, and dilated fundus examination (DFE). PARTICIPANTS: A total of 206 eyes of 103 diabetic patients selected to represent all levels of DR. METHODS: Subjects had DiSLO200, ETDRS 7-standard field film photographs, and DFE. Images were graded for severity and distribution of DR lesions. Discrepancies were adjudicated, and images were compared side by side. MAIN OUTCOME MEASURES: Distribution of hemorrhage and/or microaneurysm (H/Ma), venous beading (VB), intraretinal microvascular abnormality (IRMA), and new vessels elsewhere (NVE). Kappa (κ) and weighted κ statistics for agreement. RESULTS: The distribution of DR severity by ETDRS 7-standard field film photographs was no DR 12.5%; nonproliferative DR mild 22.5%, moderate 30%, and severe/very severe 8%; and proliferative DR 27%. Diabetic retinopathy severity between DiSLO200 and ETDRS film photographs matched in 80% of eyes (weighted κ = 0.74,κ = 0.84) and was within 1 level in 94.5% of eyes. DiSLO200 and DFE matched in 58.8% of eyes (weighted κ = 0.69,κ = 0.47) and were within 1 level in 91.2% of eyes. Forty eyes (20%) had DR severity discrepancies between DiSLO200 and ETDRS film photographs. The retinal lesions causing discrepancies were H/Ma 52%, IRMA 26%, NVE 17%, and VB 4%. Approximately one-third of H/Ma, IRMA, and NVE were predominantly outside ETDRS fields. Lesions identified on DiSLO200 but not ETDRS film photographs suggested a more severe DR level in 10% of eyes. Distribution in the temporal, superotemporal, inferotemporal, superonasal, and inferonasal fields was 77%, 72%, 61%, 65%, and 59% for H/Ma, respectively (P<0.0001); 22%, 24%, 21%, 28%, and 22% for VB, respectively (P = 0.009); 52%, 40%, 29%, 47%, and 36% for IRMA, respectively (P<0.0001), and 8%, 4%, 4%, 8%, and 5% for NVE, respectively (P = 0.03). All lesions were more frequent in the temporal fields compared with the nasal fields (P<0.0001). CONCLUSIONS: DiSLO200 images had substantial agreement with ETDRS film photographs and DFE in determining DR severity. On the basis of DiSLO200 images, significant nonuniform distribution of DR lesions was evident across the retina. The additional peripheral lesions identified by DiSLO200 in this cohort suggested a more severe assessment of DR in 10% of eyes than was suggested by the lesions within the ETDRS fields. However, the implications of peripheral lesions on DR progression within a specific ETDRS severity level over time are unknown and need to be evaluated prospectively.

Comparison of low-light nonmydriatic digital imaging with 35-mm ETDRS seven-standard field stereo color fundus photographs and clinical examination.

PURPOSE: To compare agreement between diagnosis of clinical level of diabetic retinopathy (DR) and diabetic macular edema (DME) derived from nonmydriatic fundus images using a digital camera back optimized for low-flash image capture (MegaVision) compared with standard seven-field Early Treatment Diabetic Retinopathy Study (ETDRS) photographs and dilated clinical examination. Subject comfort and image acquisition time were also evaluated. SUBJECTS AND METHODS: In total, 126 eyes from 67 subjects with diabetes underwent Joslin Vision Network nonmydriatic retinal imaging. ETDRS photographs were obtained after pupillary dilation, and fundus examination was performed by a retina specialist. RESULTS: There was near-perfect agreement between MegaVision and ETDRS photographs (κ=0.81, 95% confidence interval [CI] 0.73-0.89) for clinical DR severity levels. Substantial agreement was observed with clinical examination (κ=0.71, 95% CI 0.62-0.80). For DME severity level there was near-perfect agreement with ETDRS photographs (κ=0.92, 95% CI 0.87-0.98) and moderate agreement with clinical examination (κ=0.58, 95% CI 0.46-0.71). The wider MegaVision 45° field led to identification of nonproliferative changes in areas not imaged by the 30° field of ETDRS photos. Field area unique to ETDRS photographs identified proliferative changes not visualized with MegaVision. Mean MegaVision acquisition time was 9:52 min. After imaging, 60% of subjects preferred the MegaVision lower flash settings. CONCLUSIONS: When evaluated using a rigorous protocol, images captured using a low-light digital camera compared favorably with ETDRS photography and clinical examination for grading level of DR and DME. Furthermore, these data suggest the importance of more extensive peripheral images and suggest that utilization of wide-field retinal imaging may further improve accuracy of DR assessment.

Nonmydriatic ultrawide field retinal imaging compared with dilated standard 7-field 35-mm photography and retinal specialist examination for evaluation of diabetic retinopathy.

PURPOSE: To compare nonmydriatic stereoscopic Optomap ultrawide field images with dilated stereoscopic Early Treatment Diabetic Retinopathy Study 7-standard field 35-mm color 30-degree fundus photographs (ETDRS photography) and clinical examination for determining diabetic retinopathy (DR) and diabetic macular edema (DME) severity. DESIGN: Single-site, prospective, comparative, instrument validation study. METHODS: 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. RESULTS: 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% (K(W) = 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% (K(W) = 0.71; K = 0.61). Nonmydriatic ultrawide field imaging acquisition time was less than half that of dilated ETDRS photography (P < .0001). CONCLUSIONS: 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.

Automated Retinal Imaging System (ARIS) compared with ETDRS protocol color stereoscopic retinal photography to assess level of diabetic retinopathy.

BACKGROUND: Early Treatment Diabetic Retinopathy Study (ETDRS) seven-standard-field color stereoscopic retinal photography (ETDRS photos) has been a gold standard for determining diabetic retinopathy (DR) severity. The Automated Retinal Imaging System (ARIS™, model 110, Visual Pathways, Inc., Prescott, AZ) acquires seven-sequential color stereoscopic digital images (ARIS images) by a semiautomated technician-run process generally corresponding to ETDRS photos. We assessed the correlation between a single semiautomated ARIS imaging session without any re-imaging and ETDRS photos performed by a certified photographer for the determination of DR severity. METHODS: Two independent masked readers graded mydriatic ARIS images and ETDRS photos. A third masked retinal specialist adjudicated discrepancies. Correlation between the two modalities was compared using weighted-κ statistics. RESULTS: We evaluated 211 eyes of 106 patients with varying levels of DR. Partially ungradable images were present in 3.4% of ETDRS photos versus 31.8% of ARIS images. Exact agreement and agreement within one level between ETDRS photos and ARIS images using only completely gradable image sets occurred in 69% (κ=0.81) and 90% of cases, respectively. Exact agreement for clinically significant macular edema was 92.1% (κ=0.59). There was 100% agreement for eyes with high-risk proliferative DR. Within one level of DR severity, 100% agreement occurred for the following: questionable nonproliferative DR (NPDR), moderate NPDR, and severe NPDR. CONCLUSIONS: Results suggest that semiautomated ARIS images compare favorably with ETDRS photos when full image sets can be obtained; however, partially ungradable image sets occurred almost 10 times more frequently with ARIS images than with ETDRS photos. In the two-thirds of cases where ARIS images can be utilized, ARIS can obtain retinal images comparable to ETDRS photos while requiring less highly trained personnel than generally needed for standard ETDRS photos.

Imager evaluation of diabetic retinopathy at the time of imaging in a telemedicine program.

OBJECTIVE: To evaluate the ability of certified retinal imagers to identify presence versus absence of sight-threatening diabetic retinopathy (stDR) (moderate nonproliferative diabetic retinopathy or worse or diabetic macular edema) at the time of retinal imaging in a telemedicine program. RESEARCH DESIGN AND METHODS: Diabetic patients in a primary care setting or specialty diabetes clinic received Joslin Vision Network protocol retinal imaging as part of their care. Trained nonphysician imagers graded the presence versus absence of stDR at the time of imaging. These gradings were compared with masked gradings of certified readers. RESULTS: Of 158 patients (316 eyes) imaged, all cases of stDR (42 eyes [13%]) were identified by the imagers at the time of imaging. Six eyes with mild nonproliferative diabetic retinopathy were graded by the imagers to have stDR (sensitivity 1.00, 95% CI 0.90-1.00; specificity 0.97, 0.94-0.99). CONCLUSIONS: Appropriately trained imagers can accurately identify stDR at the time of imaging.

Telemedicine and diabetic retinopathy: moving beyond retinal screening.

Current projections estimate that diabetes mellitus will afflict over 439 million individuals worldwide by 2030. The task of detecting and evaluating for the presence and severity of retinopathy in the populations with diabetes mellitus is enormous. Although current methods of treatment are effective in reducing the risk for vision loss, a substantial proportion of patients still do not receive appropriate eye care. The use of an ocular telemedicine-based approach has the potential to expand the reach of these highly effective treatments to virtually any location. Novel methods of image acquisition and analysis, as well as the identification of predictive biomarkers, will need to be developed to further enhance this approach of eye care delivery. In addition, such programs will allow the rapid transfer of clinically relevant discoveries and will allow a considerably larger benefit to a broader patient population.

Ocular telemedicine for diabetic retinopathy and the Joslin Vision Network.

Diabetic retinopathy (DR) is the most common microvascular complication of diabetes. The Joslin Vision Network Diabetes Eye Care Program (JVN) is a validated ocular telemedicine program developed at the Joslin Diabetes Center that has provided diabetes eye care to over 70,000 persons. The JVN allows accurate assessment of level of DR severity, detects the presence of nondiabetic eye disease, and allows determination of appropriate treatment recommendations. The JVN integrates eye care in a comprehensive diabetes program, extends access to evidence-based diabetes eye care, and offers alternative means of diabetes eye care in appropriate settings, ultimately preserving vision and preventing visual loss.

Effect of systemic medications on onset and progression of diabetic retinopathy.

Diabetic retinopathy remains a leading cause of visual loss worldwide. Patients with diabetes mellitus commonly have multiple comorbidities treated with a wide variety of medications. Systemic medications that target glycemic control and coexisting conditions may have beneficial or deleterious effects on the onset or progression of diabetic retinopathy. In addition, data is accumulating to suggest that the use of systemic therapy primarily to address ocular complications of diabetic retinopathy may be a promising therapeutic approach. This article reviews our current understanding of the ocular-specific effects of systemic medications commonly used by patients with diabetes mellitus, including those directed at control of hyperglycemia, dyslipidemia, hypertension, cardiac disease, anemia, inflammation and cancer. Current clinical evidence is strongest for the use of angiotensin-converting enzyme inhibitors and angiotensin-2 receptor blockers in preventing the onset or slowing the progression of early diabetic retinopathy. To a more limited extent, evidence of a benefit of fibrates for diabetic macular edema exists. Numerous other agents hold considerable promise or potential risk. Thus, these compounds must undergo further rigorous study to determine the actual clinical efficacy and adverse effects before definitive therapeutic care recommendations can be offered.

Ocular telehealth initiatives in diabetic retinopathy.

Diabetic retinopathy (DR) is a common complication of diabetes mellitus and a leading cause of new-onset vision loss in adults worldwide. Current medical and surgical evidence-based care, including laser photocoagulation, is effective in preserving vision. This care is most effective prior to the onset of ocular or visual symptoms, but many diabetic persons do not receive the recommended annual eye examination for the evaluation of the retina for level of DR. With diabetes incidence and prevalence increasing at epidemic rates and the prediction that 370 million people worldwide will have diabetes by the year 2030, human and fiscal resources will be unable to meet the visual needs with current acute care methods. Appropriate and validated telemedicine programs for DR hold the promise of both enrolling patients into appropriate eye care programs and, more importantly, providing more effective, high-quality diabetes eye care based on current and developing technology.

A severity scale for diabetic macular edema developed from ETDRS data.

PURPOSE: To develop a severity scale for diabetic macular edema (DME) and to assess relationships between severity and duration of DME and visual acuity (VA). METHODS: From the Early Treatment Diabetic Retinopathy Study (ETDRS), mean baseline VA scores were tabulated for 7422 eyes cross-classified by (1) location of retinal thickening (RT) and its area within 1 disc diameter of the macular center, and (2) degree of RT at the center. Adjacent (row, column, and off-diagonal) cells with the greatest similarity in baseline VA (mean and SD) based on a Gaussian (normal) likelihood were merged. An initial eight-step scale was chosen using the Schwarz criterion (Bayesian information criterion; BIC) and was revised based on clinical judgment to nine steps. Relationships between baseline VA and other photographic and fluorescein angiographic characteristics were examined singly and in combination with the scale. RESULTS: Modeling baseline VA as a function of the nine-step scale yielded an R(2) of 38.0%, compared with 38.4% using the full cross-classification of these variables. Addition of each of the other baseline characteristics changed the adjusted R(2) for the combination very little. Between scale levels 1A and 5B mean (SD) VA decreased from 86.8 (5.8) letters to 59.8 (13.6) letters. In a model of change in VA as a function of time spent at each DME severity level, VA loss increased progressively from 1 letter per year at level 2 to 17 letters per year at level 5B. CONCLUSIONS: The scale facilitates documentation of the relationship of severity and duration of DME with VA.

The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy.

OBJECTIVE: The objective of this study was to determine the sensitivity and specificity of Joslin Vision Network nonmydriatic digital stereoscopic retinal imaging (NMDSRI) as a screening tool in detecting diabetic retinopathy. RESEARCH DESIGN AND METHODS: We reviewed the records of 244 patients with diabetes who had a dilated funduscopic examination (DFE) and NMDSRI done within 1 year of each other at four locations in the metropolitan Washington, DC, area. The images were transmitted through a local area network to a central reading location where they were graded by a single retinal specialist. RESULTS: Images of 482 eyes from 243 patients were included in the study. Four images did not transmit, and 35% of the images were not gradable. Of the remaining 311 eyes, there was 86% agreement in the grading between NMDSRI and DFE: 227 eyes with no diabetic retinopathy and 40 eyes with diabetic retinopathy. In 46 eyes (15%) there was a disagreement between gradings made by the two techniques. NMDSRI detected diabetic retinopathy in 35 eyes reported as normal by DFE, and in the remaining 11 eyes, the DFE grade was one grade higher than the NMDSRI grade. Adjudicated nonconcordant examinations were within one grade. In the 76 eyes with diabetic retinopathy, retinal thickness could not be assessed in 17 (21%) eyes. When the NMDSRI result was gradable, the overall sensitivity of NMDSRI was 98% and the specificity was 100% for retinopathy within one grade of the DFE. In the limited number of eyes that had diabetic retinopathy with macular edema (six), agreement with the clinical examination was 100%. CONCLUSIONS: NMDSRI is a sensitive and specific method for the screening and diagnosis of diabetic retinopathy, which may help improve compliance with the standards of eye care for patients with diabetes.

Comparison of nonmydriatic digital retinal imaging versus dilated ophthalmic examination for nondiabetic eye disease in persons with diabetes.

OBJECTIVE: To evaluate the ability of stereoscopic nonmydriatic digital retinal imaging to detect ocular pathologic features other than diabetic retinopathy (DR) in patients with diabetes mellitus (DM) compared with dilated retinal examination by retinal specialist ophthalmologists. DESIGN: Clinic-based comparative instrument study and retrospective chart review. PARTICIPANTS: Two hundred eighty Joslin Diabetes Center outpatients (560 eyes) with type 1 or type 2 DM. METHODS: Nonsimultaneous stereoscopic nonmydriatic digital retinal images (640 x 480 pixels) of three 45 degrees retinal fields were acquired and graded for clinical level of DR and other ocular pathologic features by certified readers according to Joslin Vision Network (JVN) protocol. Retrospective chart review compared findings from JVN digital images with findings from dilated retinal examination by retinal specialists performed within an average of 39.6 days of digital imaging. An independent senior retinal specialist adjudicated disagreements by review of 7 standard field 35-mm Early Treatment Diabetic Retinopathy Study protocol fundus photographs and JVN images. MAIN OUTCOME MEASURES: Detection of non-DR ocular pathologic features by digital imaging as compared with clinical examination. RESULTS: Nonmydriatic digital evaluation identified at least 1 non-DR ocular finding in 40.7% of patients (114/280). Non-diabetes mellitus ocular pathologic features identified by digital images, clinical examination, or both included cataract (n = 100); age-related maculopathy (n = 52); suspicion of glaucoma (n = 18); choroidal lesions (n = 18); evidence of systemic disorder (e.g., hypertension or renal disease; n = 15); epiretinal membrane (n = 11); chorioretinal atrophy, scar, or both (n = 6); retinal emboli (n = 3); retinitis pigmentosa (n = 1); and asteroid hyalosis (n = 1). Agreement of nonmydriatic imaging with clinical examination for presence and absence of these findings was 95.4%, 91.3%, 98.2%, 98.6%, 98.2%, 99.6%, 100%, 100%, 100%, and 100%, respectively. Kappa values for all non-DR lesions demonstrated near perfect agreement (kappa> or =0.80) except for age-related maculopathy (kappa = 0.71) and choroidal lesions (kappa = 0.73), where agreement was substantial. Overall, only 55 eyes (9.8%) were ungradable for level of DR and 85 eyes (15.2%) were ungradable for macular edema. CONCLUSIONS: Joslin Vision Network nonmydriatic digital imaging demonstrated excellent agreement with dilated ophthalmic examination by retinal specialists in the detection of ocular disease other than DR, suggesting a potential role for this technology in evaluating non-DR disorders and highlighting the extent of findings other than retinopathy in patients with diabetes.

Nonmydriatic teleretinal imaging improves adherence to annual eye examinations in patients with diabetes.

We studied whether nonmydriatic digital retinal imaging with remote interpretation (teleretinal imaging) in the ambulatory care setting affected adherence to annual dilated eye examinations among patients with diabetes. We randomly assigned 448 patients to a teleretinal imaging group or a control group. We measured the number of patients who had dilated eye examinations within 12 months of group assignment and the agreement for level of diabetic retinopathy between teleretinal imaging and the eye examinations. The teleretinal imaging group (n = 223) had significantly more dilated eye examinations than the control group (n = 225). Teleretinal imaging and eye examination results showed significant correlation and moderate agreement. Cataract and smaller pupil size were significantly associated with ungradable retinal images. Two-thirds of patients with ungradable images had other ocular findings. Patients reported high satisfaction with nonmydriatic teleretinal imaging. Nonmydriatic teleretinal imaging improves diabetic retinopathy assessment rates.

Nonmydriatic digital imaging alternative for annual retinal examination in persons with previously documented no or mild diabetic retinopathy.

PURPOSE: To prospectively evaluate the Joslin Vision Network (JVN) for follow-up annual retinal examination for level of diabetic retinopathy (DR). DESIGN: Prospective cohort study. METHODS: Fifty-two patients with no or mild nonproliferative DR (Early Treatment Diabetic Retinopathy Study [ETDRS] level < or = 35) and no diabetic macular edema (DME) at dilated retinal examination 11 or more months earlier were imaged. Patients then had dilated retinal examination and color 35-mm seven standard field stereoscopic photography (ETDRS photographs) and completed a satisfaction survey. Level of DR determined from JVN images, clinical examination, and ETDRS photographs was compared. RESULTS: Two (1.9%) eyes had JVN images ungradable for level of DR. In the 102 gradable eyes (98.1%), JVN diagnosis exactly matched clinical examination for level of DR in 82 eyes (77.9%) and was within one level of DR in all eyes (100%). Three eyes (2.9%) had JVN images ungradable for DME; one of these eyes had DME by clinical examination. JVN diagnosis matched clinical examination for DME in all eyes (101) gradable by JVN. Fifty patients (96.1%) reported JVN imaging improved their understanding of eye disease, 100% were satisfied with JVN, and forty-eight (92.3%) would consider replacing dilated examination by their eye doctor with JVN imaging. CONCLUSIONS: JVN digital imaging closely matched clinical examination for level of DR and DME, would have resulted in no patients receiving less stringent follow-up, and was well accepted by patients. JVN digital imaging may be a suitable alternative for annual dilated retinal examination for determining level of DR or DME and appropriate follow-up comprehensive ophthalmic examination.

Emerging trends in ocular telemedicine: the diabetic retinopathy model.

Diabetes mellitus is a leading cause of vision loss in industrialized countries. Diabetic retinopathy has features which make it ideal for disease management by telemedicine. The American Telemedicine Association (ATA) has recently established consensus recommendations for ocular telemedicine for diabetic retinopathy, in cooperation with the US National Institute of Standards and Technology. The guiding principle is that it would be inappropriate to use telemedicine to provide anything less than the accepted standard of clinical care. The ATA practice recommendations delineate performance standards for the clinical, technical and administrative elements of ocular telemedicine for diabetic retinopathy. Four clinical categories of assessment were identified. Category 4 validation, for example, indicates that a system matches or exceeds the ability of current photographs to identify lesions of diabetic retinopathy. To create the practice recommendations, workshops were held to address each of the three components: (1) clinical, (2) technical, and (3) operational and business. Ocular telemedicine programmes will need to demonstrate sustainability and cost-effectiveness, and respect a patient's right to privacy. Nevertheless, ocular telemedicine seems poised to become an integral part of eye health care, as long as programmes meet or exceed present clinical standards of care, and patient and provider expectations are clearly defined.

A telemedicine program for diabetic retinopathy in a Veterans Affairs Medical Center--the Joslin Vision Network Eye Health Care Model.

PURPOSE: To extend access to diabetic eye care and characterize the extent of diabetic retinopathy {DR) and other ocular findings using the Joslin Vision Network (JVN). DESIGN: Retrospective observational cohort study. METHODS: Outpatients at the Togus VA Medical Center with diabetes mellitus, impaired fasting glucose, or impaired glucose tolerance underwent JVN protocol imaging. Images were transmitted to the Joslin Diabetes Center for grading and recommended treatment plan. RESULTS: The study included 1,219 patients (2,437 eyes); 1,536 eyes (63.0%) had no (DR), 389 (16.0%) had mild nonproliferative DR (NPDR), 105 (4.3%) moderate NPDR, 35 (1.4%) severe NPDR, 20 (0.8%) very severe NPDR, and 21 (0.9%) had proliferative DR (PDR). Regarding diabetic macular edema (DME), 1,907 eyes (78.3%) had no DME, 34 (1.4%) had early DME, and 16 (0.7%) had clinically significant macular edema (CSME). Of all patients, 354 (29.0%) had either no DR or mild NPDR in both eyes, no evidence of DME, and no significant nondiabetic findings; 679 (55.7%) had no DR in either eye, and 229 (18.8%) had mild NPDR in the more severe eye. Of the 908 patients (74.5%) with either no DR or mild NPDR in the more severe eye, 533 (58.7%) had at least one nondiabetic ocular finding necessitating referral. Finally, 320 eyes (13.1%) were ungradable for both DR and DME and 160 (6.6%) were ungradable for DME alone. CONCLUSION: In a non-ophthalmic setting, JVN identifies the severity of DR and nondiabetic ocular conditions, permitting appropriate triage for eye care.