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Diabetic macular edema (DME), characterized by exudative fluid accumulation in the macula, is the most common form of sight-threatening retinopathy in patients with diabetes. The management of DME has changed considerably in recent years, especially following the development of intravitreal anti-vascular endothelial growth factor therapy which has emerged as a first-line therapy for center-involved DME. Laser treatment, intravitreal steroid therapy, and vitrectomy are also important treatment options for DME. We believe that it is important to choose the most appropriate treatment option for DME based on the clinical evidences, in addition to the careful consideration of individual patients’ general or ocular condition, DME characteristics, patients’ motivation, and compliance to the treatment in real-world clinical practice. In this review, we have summarized important clinical evidences for the main treatments for DME, presented an expert review for these evidences, and proposed a recommended therapeutic flow chart for DME. We hope that our review of the clinical evidences and the recommended therapeutic flow chart for DME will contribute to better treatment outcome for DME.

To investigate the incidence of macular hole (MH) during pars plana vitrectomy (PPV) for submacular hemorrhage (SMH) due to either retinal arterial macroaneurysm (RAM) rupture or age-related macular degeneration (AMD). We retrospectively evaluated 47 eyes of 47 patients with SMH due to RAM rupture or AMD who underwent PPV. The presence or development of MHs was confirmed intraoperatively by the surgeon. We compared the incidence of MH between the RAM and AMD groups. In the RAM group, a MH was found in five of 28 (17.9%) eyes, and a MH was developed in three eyes by the surgical procedure. In the AMD group, there was no MH. All MHs were identified intraoperatively and closed by the same surgical procedure. In the RAM group, subretinal tissue plasminogen activator (t-PA) injection was performed in 12 eyes. Of the 12 eyes, two developed an MH before t-PA subretinal injection. Of the remaining 10 eyes, four (40%) developed an MH intraoperatively or postoperatively. MHs are complications of PPV for SMH that occur more frequently in patients with SMH due to RAM rupture than in patients with SMH due to AMD.

This prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.

PurposeTo create a model for prediction of postoperative visual acuity (VA) after vitrectomy for macular hole (MH) treatment using preoperative optical coherence tomography (OCT) images, using deep learning (DL)–based artificial intelligence.MethodsThis was a retrospective single-center study. We evaluated 259 eyes that underwent vitrectomy for MHs. We divided the eyes into four groups, based on their 6-month postoperative Snellen VA values: (A) ≥ 20/20; (B) 20/25–20/32; (C) 20/32–20/63; and (D) ≤ 20/100. Training data were randomly selected, comprising 20 eyes in each group. Test data were also randomly selected, comprising 52 total eyes in the same proportions as those of each group in the total database. Preoperative OCT images with corresponding postoperative VA values were used to train the original DL network. The final prediction of postoperative VA was subjected to regression analysis based on inferences made with DL network output. We created a model for predicting postoperative VA from preoperative VA, MH size, and age using multivariate linear regression. Precision values were determined, and correlation coefficients between predicted and actual postoperative VA values were calculated in two models.ResultsThe DL and multivariate models had precision values of 46% and 40%, respectively. The predicted postoperative VA values on the basis of DL and on preoperative VA and MH size were correlated with actual postoperative VA at 6 months postoperatively (P < .0001 and P < .0001, r = .62 and r = .55, respectively).ConclusionPostoperative VA after MH treatment could be predicted via DL using preoperative OCT images with greater accuracy than multivariate linear regression using preoperative VA, MH size, and age.

To assess the interaction between ranibizumab, aflibercept, and mouse vascular endothelial growth factor (VEGF), both in vivo and in vitro. In vivo, the effect of intravitreal injection of ranibizumab and aflibercept on oxygen induced retinopathy (OIR) and the effect of multiple intraperitoneal injections of ranibizumab and aflibercept on neonatal mice were assessed. In vitro, the interaction of mouse VEGF-A with aflibercept or ranibizumab as the primary antibody was analyzed by Western blot. In both experiments using intravitreal injections in OIR mice and multiple intraperitoneal injections in neonatal mice, anti-VEGF effects were observed with aflibercept, but not with ranibizumab. Western blot analysis showed immunoreactive bands for mouse VEGF-A in the aflibercept-probed blot, but not in the ranibizumab-probed blot. Aflibercept but not ranibizumab interacts with mouse VEGF, both in vivo and in vitro. When conducting experiments using anti-VEGF drugs in mice, aflibercept is suitable, but ranibizumab is not.

Purpose To evaluate the changes in axial length (AL) and corneal astigmatism induced by scleral imbrication on all quadrants in pig eyes. Study design Experimental study Methods We produced scleral imbrications either on all quadrants or on 2 consecutive quadrants of 5 enucleated pig eyes. Scleral imbrications 8 mm wide were made at 8 mm from the limbus on each quadrant. We determined the AL using an electronic caliper and the corneal astigmatism using a keratometer before and after the 2 types of scleral imbrications and compared the changes in ocular AL and corneal astigmatism induced by the 2 surgical procedures. Results The AL reduction after the scleral imbrication on all quadrants (3.96 ± 0.56 mm) was larger than that on 2 quadrants (2.39 ± 0.41 mm) ( P  = .001). The change in corneal astigmatism induced by imbrication on all quadrants (2.98 ± 1.96 D) was less than that on 2 quadrants (5.95 ± 2.04 D) ( P  < .029). Conclusions Scleral imbrication on all quadrants induced a shorter AL and less corneal astigmatism than did a standard scleral imbrication on 2 quadrants. Therefore, the former could be a more effective operation for retinal disorders associated with high myopia, including macular hole retinal detachment and myopic foveoschisis.

We quantitatively determined the relation between the decrease in orbital fat and enophthalmos due to bimatoprost using magnetic resonance imaging (MRI). Nine orbits in nine patients were treated unilaterally with bimatoprost for glaucoma or ocular hypertension. The contralateral orbits were used as controls. The volumes of the orbital tissues and the enophthalmos were measured using MRI. The mean volumes on the treated and untreated sides were, respectively, 14.6 ± 2.1 and 17.0 ± 4.3 cm3 for orbital fat (P = 0.04) and 3.4 ± 0.5 and 3.3 ± 0.5 cm3 for total extraocular muscles (P = 0.85). The mean enophthalmos values were 14.7 ± 2.5 and 16.0 ± 2.3 mm on the treated and untreated sides, respectively (P = 0.002). The data acquired by quantitatively measuring the volumes of orbital fat and enophthalmos on MRI showed that each might be reduced by bimatoprost administration. The enophthalmos could be caused by the bimatoprost-induced decrease in orbital fat.

Purpose To investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME). Study design Prospective, open-label, multicenter, single-arm, nonblinded clinical study. Methods Forty eyes of 40 patients with DME received a T&E regimen of intravitreal aflibercept injection (IAI) with the longest treatment interval set to 16 weeks and adjunct focal/grid laser for 1 year. An intent-to-treat analysis was performed using the same last-observation-carried-forward method. A per-protocol analysis was also performed for patients who completed a 1-year T&E regimen. The primary endpoints were mean changes in best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Secondary endpoints included IAI-interval extension and resultant IAI numbers and the association between an early response to IAI and final BCVA gain at 1 year. Results Thirty-one patients (77.5%) completed the 1-year aflibercept T&E regimen. In these per-protocol participants, the mean CST improvement/reduction was 187.3 ± 145.0 µm ( P  < .001), but the mean BCVA gain was limited to 4.3 ± 12.2 letters ( P  = .782). Subanalysis revealed that eyes that gained ≥ 4 letters (median at week 12) after the initial 3 consecutive IAIs (induction phase) achieved greater vision improvement (13.8 ± 9.5 letters) than did the residual eyes (− 4.3 ± 9.2 letters) at 1 year ( P  < .001). Treatment intervals were extended to 12 and 16 weeks in 16.1% (5/31) and 45.2% (14/31) of the patients, respectively. The mean IAI number was 7.0 ± 1.1. Conclusions The results of this study suggest that although the BCVA improvement might be somewhat less than that of frequent treatment, a T&E aflibercept regimen with the longest treatment interval set to 16 weeks is a realizable rational strategy for DME treatment over 1 year.

PurposeTo investigate the blood neutrophil-to-lymphocyte ratio (NLR) as a risk factor for retinopathy of prematurity (ROP) development or treatment.MethodsRetrospective cohort study. Infants who underwent ROP screening at Shiga University of Medical Science Hospital and Omihachiman Community Medical Center between April 2010 and December 2021 were included in this study. Screening criteria were gestational age (GA) < 32 weeks or birth weight (BW) < 1500 g. Multivariate logistic regression analysis was applied to investigate whether the NLR constituted an independent risk factor for ROP development or treatment. The objective variable was ROP development or treatment, and the explanatory variables were GA, BW, NLR, maternal infection or clinical chorioamnionitis and corticosteroid use by the mother. Maternal infection or clinical chorioamnionitis and corticosteroid use by the mother was included in the explanatory variables to adjust for factors affecting the NLR.ResultsIn total, 220 infants met the inclusion criteria, of whom 125 developed ROP, whereas 95 infants did not display ROP. GA was significantly associated with ROP development (odds ratio (OR): 0.41, p < 0.001); however, the NLR was not significantly associated with ROP development (OR: 1.0, p = 0.74). Thirty-eight infants received treatment for ROP, whereas 182 infants had no such treatment. BW and the NLR were significantly associated with ROP treatment (OR: 1.6 and 0.66, p < 0.001 and 0.003, respectively).ConclusionThe NLR was not a risk factor for ROP development but was a risk factor for ROP treatment.

Purpose To investigate blood monocyte counts as a risk factor for retinopathy of prematurity (ROP) treatment. Design Retrospective cohort study. Methods Infants who underwent ROP screening at Shiga University of Medical Science Hospital between January, 2011 and July, 2021 were included in this study. Screening criteria were a gestational age (GA) < 32 weeks or birth weight (BW) < 1500 g. The week with the largest difference in monocyte counts between the infants with and without type 1 ROP determined based on the effect size. Multivariate logistic regression analysis was applied to investigate whether the monocyte counts constituted an independent risk factor for type 1 ROP. The objective variable was type 1 ROP, and the explanatory variables were GA, BW, infants’ infection, and Apgar score at 1 min and monocyte counts in the week with the largest monocyte-counts difference between the with- and without type 1 ROP groups. Results In total, 231 infants met the inclusion criteria. The monocyte counts in the fourth week after birth (4w MONO) exhibited the largest difference between infants with and without type 1 ROP. The analysis was performed on 198 infants, excluding 33 infants without 4w MONO data. Thirty-one infants had type 1 ROP, whereas 167 infants did not. BW and 4w MONO were significantly associated with type 1 ROP (odds ratio: 0.52 and 3.9, P  < .001 and 0.004, respectively). Conclusions The 4w MONO was an independent risk factor for type 1 ROP and may be useful in follow-up of infants with ROP.