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Deep Learning Predicts OCT Measures of Diabetic Macular Thickening From Color Fundus Photographs.
Arcadu, F, Benmansour, F, Maunz, A, Michon, J, Haskova, Z, McClintock, D, Adamis, AP, Willis, JR, Prunotto, M
Investigative ophthalmology & visual science. 2019;(4):852-857
Abstract
PURPOSE To develop deep learning (DL) models for the automatic detection of optical coherence tomography (OCT) measures of diabetic macular thickening (MT) from color fundus photographs (CFPs). METHODS Retrospective analysis on 17,997 CFPs and their associated OCT measurements from the phase 3 RIDE/RISE diabetic macular edema (DME) studies. DL with transfer-learning cascade was applied on CFPs to predict time-domain OCT (TD-OCT)-equivalent measures of MT, including central subfield thickness (CST) and central foveal thickness (CFT). MT was defined by using two OCT cutoff points: 250 μm and 400 μm. A DL regression model was developed to directly quantify the actual CFT and CST from CFPs. RESULTS The best DL model was able to predict CST ≥ 250 μm and CFT ≥ 250 μm with an area under the curve (AUC) of 0.97 (95% confidence interval [CI], 0.89-1.00) and 0.91 (95% CI, 0.76-0.99), respectively. To predict CST ≥ 400 μm and CFT ≥ 400 μm, the best DL model had an AUC of 0.94 (95% CI, 0.82-1.00) and 0.96 (95% CI, 0.88-1.00), respectively. The best deep convolutional neural network regression model to quantify CST and CFT had an R2 of 0.74 (95% CI, 0.49-0.91) and 0.54 (95% CI, 0.20-0.87), respectively. The performance of the DL models declined when the CFPs were of poor quality or contained laser scars. CONCLUSIONS DL is capable of predicting key quantitative TD-OCT measurements related to MT from CFPs. The DL models presented here could enhance the efficiency of DME diagnosis in tele-ophthalmology programs, promoting better visual outcomes. Future research is needed to validate DL algorithms for MT in the real-world.
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EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN.
Terasaki, H, Shiraki, K, Ohji, M, Metzig, C, Schmelter, T, Zeitz, O, Sowade, O, Kobayashi, M, Vitti, R, Berliner, A, et al
Retina (Philadelphia, Pa.). 2019;(5):938-947
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Abstract
PURPOSE To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME). METHODS VIVID-DME was a Phase 3 study comprising patients with DME randomized 1:1:1 to IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 4 weeks until Week 16 then 8-week dosing (2q8), and laser. A total of 403 patients (76 Japanese) were included in this study. VIVID-Japan (72; all Japanese patients) was a nonrandomized, open-label study comprising Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8. Primary efficacy endpoint (Week 52) of VIVID-DME was mean change from baseline in best-corrected visual acuity; VIVID-Japan evaluated safety and tolerability. RESULTS Mean change in best-corrected visual acuity (letters) for 2q4, 2q8, and laser groups was +10.6, +10.9, and +1.2 and +9.8, +9.5, and +1.1 in the non-Japanese and Japanese populations of VIVID-DME, respectively. In VIVID-Japan, it was +9.3 for IAI 2q8. Intravitreal aflibercept injection also provided consistently greater benefits for anatomical outcomes versus laser. Adverse events were consistent with the known safety profile of IAI. CONCLUSION In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.
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Three-dimensional analysis of morphologic changes and visual outcomes in diabetic macular edema.
Lee, H, Kang, KE, Chung, H, Kim, HC
Japanese journal of ophthalmology. 2019;(3):234-242
Abstract
PURPOSE To investigate the association of retinal fluid volume with the visual and anatomic outcomes of patients with diabetic macular edema (DME) after treatment with bevacizumab. STUDY DESIGN Retrospective observational study. METHODS We retrospectively analyzed 65 eyes of 58 DME patients treated with bevacizumab. The volumes of the inner intraretinal fluid (IRF) in the inner nuclear layer (INL), outer IRF in the outer plexiform layer (OPL)/outer nuclear layer (ONL), and subretinal fluid (SRF) were calculated. The correlations between the baseline fluid volumes and best-corrected visual acuity (BCVA), area of disorganization of the retinal inner layers (DRIL), disrupted external limiting membrane (ELM), and disrupted ellipsoid zone (EZ) at 12 months after treatment were assessed. RESULTS The baseline volume of the inner IRF correlated with poor BCVA at the final visit (r = 0.52, P < .001) whereas the baseline volume of the outer IRF and SRF volume did not show a significant correlation with BCVA at the final visit (P = .07 and P = .61, respectively). The improvement in BCVA correlated with the reduction in the baseline volume of the inner IRF and outer IRF (r = 0.25, P = .04 and r = 0.36, P = .003), but not with the SRF volume (P = .59). The baseline volume of the inner IRF correlated positively with the area of DRIL and the disrupted ELM at the final visit (r = 0.56, P < .001 and r = 0.25, P = .04, respectively). Such relationship remained in each quadrant of the macula (P < .005 for all quadrants). CONCLUSION The baseline volume of the inner IRF correlated with a poor visual outcome, an increased DRIL area, and a more disrupted ELM area in patients with DME after treatment with bevacizumab.
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Correlation of Macular Thickness and Visual Acuity in DME Treated by Two Doses of Intravitreal Ziv-Aflibercept Versus Bevacizumab: Analysis of a Randomized, Three-Armed Clinical Trial.
Jabbarpoor Bonyadi, MH, Baghi, A, Ramezani, A, Yaseri, M, Soheilian, M
Ophthalmic surgery, lasers & imaging retina. 2019;(11):684-690
Abstract
BACKGROUND AND OBJECTIVE To report the correlation of central macular thickness (CMT) and best-corrected visual acuity (BCVA) after 1-year treatment by two doses (2.5 mg or 1.25 mg) of intravitreal ziv-aflibercept (IVZ) versus bevacizumab (IVB) in eyes with diabetic macular edema (DME). PATIENTS AND METHODS In this study, the correlation of CMT and BCVA changes of the eyes enrolled in a previous clinical trial of 123 eyes were re-evaluated. The correlation of BCVA and CMT changes at each visit was evaluated in the three study arms individually. Then, the eyes in each of the arms were classified at each follow-up visit into three subgroups based on their CMT changes related to the baseline CMT: CMT decrease of 30% or more of baseline CMT, between 10% to 29% of baseline CMT, and less than 9% of baseline CMT or CMT increase. RESULTS BCVA and CMT changes were correlated significantly (P < .05) in all and in half of the follow-up visits, respectively, in the eyes treated by IVZ 1.25 mg and IVB (r = 0.554 and r = 0.617 at 1 year, respectively). Nevertheless, such a significant correlation was not detected in the eyes treated by IVZ 2.5 mg in any of the follow-up visits (r = 0.202 at 1 year; P = .259). In the IVZ 2.5 mg group, BCVA improvement was observed in all subgroups with each level of CMT reductions. CONCLUSION Ziv-aflibercept 2.5 mg might have a beneficial effect on DME beyond thickness reduction. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:684-690.].
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Accuracy of Detection and Grading of Diabetic Retinopathy and Diabetic Macular Edema Using Teleretinal Screening.
Date, RC, Shen, KL, Shah, BM, Sigalos-Rivera, MA, Chu, YI, Weng, CY
Ophthalmology. Retina. 2019;(4):343-349
Abstract
PURPOSE To determine the accuracy of a county teleretinal screening program of detecting referable diabetic retinopathy (DR) and treatable diabetic macular edema (DME), as well as to evaluate patient compliance with clinic follow-up after referral from teleretinal screening. DESIGN Retrospective observational study. PARTICIPANTS Patients in the Harris Health System (HHS, Houston, TX) older than 18 years of age who underwent teleretinal screening between July 2014 and July 2016. METHODS Teleretinal imaging (TRI) consisting of single-field 45-degree nonmydriatic color fundus photography with referral thresholds of severe nonproliferative DR, proliferative DR, and significant DME. Teleretinal imaging results for all referred subjects were obtained and cross-referenced with dilated fundus examination findings with regard to DR severity and the presence of DME. Follow-up status was also noted. Subjects underwent OCT if deemed necessary by the examining specialist. Agreement between TRI and dilated fundus examination (DFE) findings was determined by calculating the Cohen κ coefficient. MAIN OUTCOME MEASURES The primary outcome measure is agreement between TRI results and DFE findings with regard to DR severity and the presence of DME. The secondary outcome measure is compliance with follow-up. RESULTS Of 1767 patients who were screened and referred for clinical examination, 935 (52.9%) attended their clinic appointment. Overall agreement between DFE and TRI was moderate (weighted κ 0.45) in terms of DR severity. There was agreement within one DR severity level in 86.2% of patients. The positive predictive value for detecting referable disease was 71.3%. Of patients referred for DME, 30.4% were deemed to have treatable DME. CONCLUSIONS The HHS teleretinal screening program demonstrates a high level of accuracy in the detection and classification of referable DR, but a lesser degree of accuracy in the detection of treatable DME. Only slightly more than half of participants were compliant with follow-up after a TRI referral. This large-scale study provides insight into the utility of teleretinal screening in a county health care system.
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Higher-Order Assessment of OCT in Diabetic Macular Edema from the VISTA Study: Ellipsoid Zone Dynamics and the Retinal Fluid Index.
Ehlers, JP, Uchida, A, Hu, M, Figueiredo, N, Kaiser, PK, Heier, JS, Brown, DM, Boyer, DS, Do, DV, Gibson, A, et al
Ophthalmology. Retina. 2019;(12):1056-1066
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Abstract
PURPOSE To investigate retinal fluid features and ellipsoid zone (EZ) integrity dynamics on spectral-domain OCT (SD-OCT) in eyes with diabetic macular edema (DME) treated with intravitreal aflibercept injection (IAI) in the VISTA-DME study. DESIGN A post hoc subanalysis of a phase III, prospective clinical trial. PARTICIPANTS Eyes received either IAI 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly doses (2q8). METHODS All eyes from the VISTA Phase III study in the IAI groups imaged with the Cirrus HD-OCT system (Zeiss, Oberkochen, Germany) were included. The OCT macular cube datasets were evaluated using a novel software platform to generate retinal layer and fluid boundary lines that were manually corrected for assessment of change in EZ parameters and volumetric fluid parameters from baseline. The retinal fluid index (i.e., proportion of the retinal volume consisting of cystic fluid) was also calculated at each time point. MAIN OUTCOME MEASURES The feasibility of volumetric assessment of higher-order OCT-based retinal parameters and its correlation with best-corrected visual acuity (BCVA). RESULTS Overall, 106 eyes of 106 patients were included. Specifically, 52 eyes of 52 patients were included in the IAI 2q4 arm, and 54 eyes of 54 patients were included in the IAI 2q8 arm. Ellipsoid zone integrity metrics significantly improved from baseline to week 100, including central macular mean EZ to retinal pigment epithelium (RPE) thickness (2q4: 26.6 μm to 31.6 μm, P < 0.001; 2q8: 25.2 μm to 31.4 μm, P < 0.001). At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001). Central macular retinal fluid index (RFI) significantly improved in both arms (2q4: 17.9% to 7.2%, P < 0.001; 2q8: 19.8% to 4.2%, P < 0.001). Central macular mean EZ-RPE thickness (i.e., a surrogate for photoreceptor outer segment length) and central RFI were independently correlated with BCVA at multiple follow-up visits. CONCLUSIONS Intravitreal aflibercept injection resulted in significant improvement in EZ integrity and quantitative fluid metrics in both 2q4 and 2q8 arms and correlated with visual function.
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Comparison of macular retinal sensitivity and its contribution to the foveal sensitivity between diabetic and non-diabetic patients with normal visual acuity.
Somilleda-Ventura, SA, Ceballos-Reyes, GM, Lima-Gómez, V
Journal of optometry. 2019;(3):180-185
Abstract
PURPOSE To compare the retinal sensitivity and evaluate its contribution to the foveal sensitivity in patients with and without diabetes who maintain normal visual acuity. METHODS Observational, descriptive, cross-sectional and prospective study in 20 subjects without diabetes (group 1) and 23 with type 2 diabetes mellitus (group 2) that had no ocular abnormalities. Retinal sensitivity was measured with the macular threshold test by the Humphrey's computerized perimeter. The mean sensitivity in each of the 16 points and the foveal sensitivity were compared between groups using the Mann-Whitney's U test; the correlation between retinal sensitivity and foveal sensitivity was analyzed by the Spearman's test and the contribution of each point to the foveal sensitivity was identified by multiple regression. RESULTS Sixty eyes were evaluated, 30 in group 1 and 30 in group 2; the mean foveal sensitivity was 34.77±0.5dB in group 1 and 32.87±0.6 in group 2. The highest sensitivity of the temporal visual field had an inferior paracentral location (point 3) in both groups. In the linear regression analysis, points which contributed to the foveal sensitivity were 1 in group 1 and points 7 and 15 in group 2. CONCLUSIONS Subjects without diabetes have a significantly higher sensitivity in the temporal retina compared with those with diabetes; points with highest mean retinal sensitivity do not correspond to the central four. The reduced sensitivity in point 1 decreases the mean foveal sensitivity in subjects with diabetes, because this variable correlates with lower perimetry points.
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Aflibercept with adjuvant micropulsed yellow laser versus aflibercept monotherapy in diabetic macular edema.
Khattab, AM, Hagras, SM, AbdElhamid, A, Torky, MA, Awad, EA, Abdelhameed, AG
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2019;(7):1373-1380
Abstract
PURPOSE To assess the impact of micropulsed laser (MPL) on modifying the number of aflibercept injections when used as an adjuvant therapy in diabetic macular edema (DME). METHODS A prospective randomized interventional clinical study included patients with DME attending Al Hadi Clinic, Kuwait, during the period from May 2017 to December 2018. Patients were allocated in two groups; group A received aflibercept injections alone and group B received combined aflibercept injections followed by MPL within a week. The primary outcome was the number of Aflibercept injections in each group guided by the change in central macular thickness (CMT). All the patients were followed for 18 months. Secondary outcome measures included best corrected visual acuity (BCVA), contrast sensitivity (CS), and any recorded complications. RESULTS Fifty-four eyes of 51 patients were included (27 in each group). There was no statistically significant difference between the two groups in baseline characteristics except for the age that was statistically higher in group B (p = 0.001). The number of injections were significantly lower in group B (4.1 ± 1.1) than group A (7.3 ± 1.1) (p < 0.005). At 18th month, there was significant reduction in CMT in both groups (p < 0.005) with no statistical difference between the two groups (p = 0.989). Final BCVA in both groups showed statistically significant improvement (p < 0.005) without statistically significant difference between the two groups (p = 0.082). In both groups, the CS showed significant improvement from baseline (p < 0.005). No ocular or systemic adverse effects were observed in either group. CONCLUSION Supplemental MPL in eyes with DME may decrease the burden of the aflibercept injection frequency while resulting in comparable anatomical and visual outcomes.
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One-Time Intravitreal Injection of KVD001, a Plasma Kallikrein Inhibitor, in Patients with Central-Involved Diabetic Macular Edema and Reduced Vision: An Open-Label Phase 1B Study.
Sun, JK, Maturi, RK, Boyer, DS, Wells, JA, Gonzalez, VH, Tansley, R, Hernandez, H, Maetzel, A, Feener, EP, Aiello, LP
Ophthalmology. Retina. 2019;(12):1107-1109
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Macular vessels density in diabetic retinopathy: quantitative assessment using optical coherence tomography angiography.
AttaAllah, HR, Mohamed, AAM, Ali, MA
International ophthalmology. 2019;(8):1845-1859
Abstract
PURPOSE The aim of this study was to evaluate macular perfusion using OCTA automated software algorithms; vessel area density (VD) and non-flow tool to measure FAZ area in treatment-naïve diabetic eyes with moderate or severe NPDR and having macular edema, and correlate these parameters with LogMAR (logarithm of the minimum angle of resolution) visual acuity. Diabetic eyes without macular edema were included, to detect and define differences within the parameters between diabetic eyes with and without macular edema. METHODS Forty-five diabetic eyes with diabetic macular edema, forty diabetic eyes without macular edema, and forty eyes of healthy controls were examined using OCTA (RTVue-XR Avanti; Optovue, Inc, Fremont, CA). The macular vessel area density (VD) and foveal avascular zone (FAZ) area were assessed and statistically compared between the three groups and also correlated with the foveal thickness and visual acuity. Data were entered and analyzed by SPSS 19. Quantitative data were presented as mean and standard deviation, and qualitative data presented as frequency distribution; independent samples t test, Chi square test and Pearson correlation were done. RESULTS Mean whole image VD was 44.4 ± 3.6 in diabetic eyes with DME, 45.6 ± 4.2 in diabetics without DME, and 49 ± 3.9 in control eyes (P = 0.001). Diabetic eyes with DME had significantly lower vessels density values at the level of the deep retinal plexus (in the parafoveal, superior hemi, inferior hemi, temporal, superior, and nasal areas), when compared with diabetic eyes without DME. In diabetic eyes with DME, significant fair negative correlation was found between whole image vessels density at the level of the superficial retinal plexus and LogMAR VA (r = - 0.313, P = 0.036). Also, a significant fair positive correlation was found between FAZ area (at both the superficial and deep retinal plexus) and LogMAR visual acuity, in diabetic eyes with DME, where eyes with larger FAZ area had worse vision (P = 0.005 and P = 0.016, respectively). Diabetic eyes with DME had significantly larger FAZ area at the level of the superficial capillary plexus (mean superficial FAZ ± SD 0.55 ± 0.25) than diabetic eyes without edema (mean superficial FAZ ± SD 0.41 ± 0.12) and control subjects (mean superficial FAZ ± SD 0.35 ± 0.09). CONCLUSION Using OCTA machine with AngioAnalytics parameters (vessel area density and non-flow area) helped in objective quantification of macular perfusion and accurately measuring the FAZ area in diabetic eyes with macular edema. Both parameters were significantly correlated with visual function in treatment-naïve diabetic eyes with edema. These OCTA biomarkers could be used to predict visual function in such eyes, to monitor response to treatment.