Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials.

PURPOSE: To evaluate 1-year efficacy, durability, and safety of faricimab among patients from Asian countries in the TENAYA/LUCERNE trials of neovascular age-related macular degeneration (nAMD). METHODS: Treatment-naïve patients with nAMD were randomly assigned (1:1) to faricimab 6.0 mg up to every 16 weeks (Q16W), based on disease activity at weeks 20 and 24, or aflibercept 2.0 mg Q8W. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. RESULTS: In the pooled TENAYA/LUCERNE trials, there were 120 (9.0%) and 1209 (91.0%) patients in the Asian (faricimab n = 61; aflibercept n = 59) and non-Asian country (faricimab n = 604; aflibercept n = 605) subgroups, respectively. In the Asian country subgroup, mean BCVA change from baseline at the primary endpoint visits was 7.1 (95% CI, 4.3-9.8) letters with faricimab and 7.2 (4.4-10.0) letters with aflibercept. In non-Asian country patients, mean vision gains were 6.1 (5.2-7.1) and 5.7 (4.8-6.7) letters with faricimab and aflibercept, respectively. At week 48, 59.6% of Asian country patients in the faricimab group achieved Q16W dosing (vs. 43.9% non-Asian) and 91.2% achieved ≥ Q12W dosing (vs. 77.5% non-Asian). Central subfield thickness reductions were similar between the subgroups, with meaningful and similar reductions from baseline observed at the primary endpoint visits and over time. Faricimab was well tolerated in both subgroups, with an acceptable safety profile. CONCLUSION: Consistent with the global TENAYA/LUCERNE findings, faricimab up to Q16W showed sustained visual and anatomical benefits in patients with nAMD from Asian and non-Asian countries. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03823287 (TENAYA); NCT03823300 (LUCERNE). Date of registration: January 30, 2019.

Degradation Behavior of Poly(Lactide-Co-Glycolide) Monolayers Investigated by Langmuir Technique: Accelerating Effect.

Among biodegradable polymers, polylactides (PLAs) have attracted considerable interest because the monomer can be produced from renewable resources. Since their initial degradability strongly affects commercial application fields, it is necessary to manage the degradation properties of PLAs to make them more commercially attractive. To control their degradability, poly(lactide-co-glycolide) (PLGA) copolymers of glycolide and isomer lactides (LAs) were synthesized, and their enzymatic and alkaline degradation rates of PLGA monolayers as functions of glycolide acid (GA) composition were systematically investigated by the Langmuir technique. The results showed that the alkaline and enzymatic degradations of PLGA monolayers were faster than those of l-polylactide (l-PLA), even though proteinase K is selectively effective in the l-lactide (l-LA) unit. Alkaline hydrolysis was strongly affected by their hydrophilicity, while the surface pressure of monolayers for enzymatic degradations was a major factor.

The Association of Pachydrusen Characteristics with Choroidal Thickness and Patient's Age in Polypoidal Choroidal Vasculopathy versus Central Serous Chorioretinopathy.

We investigated the relationship between pachydrusen and choroidal thickness and age in eyes with polypoidal choroidal vasculopathy (PCV) and fellow eyes, compared to eyes with central serous chorioretinopathy (CSC). This retrospective study included 89 eyes with PCV and 146 eyes with CSC. The number, location, and shape of the pachydrusen and their association with choroidal thickness and age were analyzed. PCV eyes showed pachydrusen more frequently than eyes with CSC (52% vs. 20%, p < 0.001). Large solitary type and clustered type were more frequent in PCV eyes compared to CSC eyes (p = 0.003 and p = 0.001, respectively). Subfoveal choroidal thickness was associated with pachydrusen in eyes with PCV (odds ratio [OR] 1.006, 95% confidence interval [CI] 1.001−1.011, p = 0.027), while age was associated with pachydrusen in CSC eyes (OR 1.137, 95% CI, 1.073−1.205; p < 0.001). Pachydrusen were localized directly over the pachyvessel on optical coherence tomographic findings in approximately two thirds of PCV eyes and fellow eyes (62% and 67%, respectively). Risk factors for pachydrusen differ according to diseases. The presence of pachydrusen was associated with choroidal thickness in PCV, while the association with age was more prominent in CSC.

Polypoidal Choroidal Vasculopathy: Consensus Nomenclature and Non-Indocyanine Green Angiograph Diagnostic Criteria from the Asia-Pacific Ocular Imaging Society PCV Workgroup.

PURPOSE: To develop consensus terminology in the setting of polypoidal choroidal vasculopathy (PCV) and to develop and validate a set of diagnostic criteria not requiring indocyanine green angiography (ICGA) for differentiating PCV from typical neovascular age-related macular degeneration (nAMD) based on a combination of OCT and color fundus photography findings. DESIGN: Evaluation of diagnostic test results. PARTICIPANTS: Panel of retina specialists. METHODS: As part of the Asia-Pacific Ocular Imaging Society, an international group of experts surveyed and discussed the published literature regarding the current nomenclature and lesion components for PCV, and proposed an updated consensus nomenclature that reflects our latest understanding based on imaging and histologic reports. The workgroup evaluated a set of diagnostic features based on OCT images and color fundus photographs for PCV that may distinguish it from typical nAMD and assessed the performance of individual and combinations of these non-ICGA features, aiming to propose a new set of diagnostic criteria that does not require the use of ICGA. The final recommendation was validated in 80 eyes from 2 additional cohorts. MAIN OUTCOME MEASURES: Consensus nomenclature system for PCV lesion components and non-ICGA-based criteria to differentiate PCV from typical nAMD. RESULTS: The workgroup recommended the terms polypoidal lesion and branching neovascular network for the 2 key lesion components in PCV. For the diagnosis of PCV, the combination of 3 OCT-based major criteria (sub-retinal pigment epithelium [RPE] ring-like lesion, en face OCT complex RPE elevation, and sharp-peaked PED) achieved an area under the receiver operating characteristic curve of 0.90. Validation of this new scheme in a separate subset 80 eyes achieved an accuracy of 82%. CONCLUSIONS: We propose updated terminology for PCV lesion components that better reflects the nature of these lesions and is based on international consensus. A set of practical diagnostic criteria applied easily to spectral-domain OCT results can be used for diagnosing PCV with high accuracy in clinical settings in which ICGA is not performed routinely.

Genetic Polymorphisms in Activating Transcription Factor 3 Binding Site and the Prognosis of Early-Stage Non-Small Cell Lung Cancer.

BACKGROUND: Activating transcription factor 3 (ATF3) plays a significant role in cancer development and progression. We investigated the association between variants in expression quantitative trait loci (eQTLs) within ATF3 binding regions and the prognosis of non-small cell lung cancer (NSCLC) after surgery. METHODS: A total of 772 patients with NSCLC who underwent curative surgery were enrolled. Using a public database (http://galaxyproject.org), we selected 104 single nucleotide polymorphisms (SNPs) in eQTLs in the ATF3 binding regions. The association of those SNPs with disease-free survival (DFS) was evaluated. RESULTS: Among those SNPs, HAX1 rs11265425T>G was associated with significantly worse DFS (aHR = 1.30, 95% CI = 1.00-1.69, p = 0.05), and ME3 rs10400291C>A was associated with significantly better DFS (aHR = 0.66, 95% CI = 0.46-0.95, p = 0.03). Regarding HAX1 rs11265425T>G, the significant association remained only in adenocarcinoma, and the association was significant only in squamous cell carcinoma regarding ME3 rs10400291C>A. ChIP-qPCR assays showed that the two variants reside in active enhancers where H3K27Ac and ATF3 binding occurs. Promoter assays showed that rs11265425 G allele had significantly higher HAX1 promoter activity than T allele. HAX1 RNA expression was significantly higher in tumor than in normal lung, and higher in rs11265425 TG+GG genotypes than in TT genotype. Conversely, ME3 expression was significantly lower in tumor than in normal lung, and higher in rs10400291 AA genotype than in CC+CA genotypes. CONCLUSIONS: In conclusion, this study shows that the functional polymorphisms in ATF3 binding sites, HAX1 rs11265425T>G and ME3 rs10400291C>A are associated with the clinical outcomes of patients in surgically resected NSCLC.

Classification of pachychoroid on optical coherence tomography using deep learning.

PURPOSE: Pachychoroid is characterized by dilated Haller vessels and choriocapillaris attenuation that are seen on optical coherence tomography (OCT) B-scans. This study investigated the feasibility of using deep learning (DL) models to classify pachychoroid and non-pachychoroid eyes from OCT B-scan images. METHODS: In total, 1898 OCT B-scan images were collected from eyes with macular diseases. Images were labeled as pachychoroid or non-pachychoroid based on strict quantitative and qualitative criteria for multimodal imaging analysis by two retina specialists. DL models were trained (80%) and validated (20%) using pretrained convolutional neural networks (CNNs). Model performance was assessed using an independent test set of 50 non-pachychoroid and 50 pachychoroid images. RESULTS: The final accuracy of AlexNet and VGG-16 was 57.52% for both models. ResNet50, Inception-v3, Inception-ResNet-v2, and Xception showed a final accuracy of 96.31%, 95.25%, 93.40%, and 92.61%, respectively, for the validation set. These models demonstrated accuracy on an independent test set of 78.00%, 86.00%, 90.00%, and 92.00%, and an F1 score of 0.718, 0.841, 0.894, and 0.920, respectively. CONCLUSION: DL models classified pachychoroid and non-pachychoroid images with good performance. Accurate classification can be achieved using CNN models with deep rather than shallow neural networks.

A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial.

INTRODUCTION: There are only a few studies on the clinical utility of filler injections for penile augmentation (PA) in patients with small penis syndrome (SPS), which is a type of anxiety or body dysmorphic disorder, not a true micropenis. AIM: To compare the clinical outcomes of hyaluronic acid (HA) with polylactic acid (PLA) filler injection for temporary PA in patients with SPS. METHODS: Our prospective, patient/evaluator-blind, comparative, randomized, non-inferiority trial consisted of a single filler injection and a 24-week post-injection period. Seventy-four men with SPS were included between November 2017 and February 2018. Patients were divided into those injected with HA (n = 39) and those injected with PLA filler (n = 35). MAIN OUTCOME MEASURE: The psychological effects of PA, based on the Beliefs about Penis Size Scale, penile girth, and satisfaction, were assessed at baseline and at 4, 12, and 24 weeks post-injection. RESULTS: At 24 weeks, the mean penile girth increases were 2.1 ± 1.0 cm (P < .001) in the HA group and 1.6 ± 0.9 cm (P < .001) in the PLA group, with a mean difference of 0.5 ± 0.2 cm between groups (P = .031). In both groups, satisfaction levels significantly increased at 24 weeks, with 1.8 ± 1.7 and 1.6 ± 1.4 mean increases in the visual analog scale for penile appearance satisfaction in the HA and PLA groups, respectively (each P < .001), and 1.0 ± 1.1 and 0.7 ± 1.2 mean increases in the visual analog scale for sexual life satisfaction in the HA and PLA groups, respectively (each P < .001), with no significant differences between groups (P = .950 and P = .287). The mean Beliefs about Penis Size Scale scores significantly decreased at 24 weeks, with 7.8 ± 8.3 and 5.3 ± 7.2 mean decreases in the HA and PLA groups, respectively (each P < .001), and no significant difference between the groups (P = .920). There were no serious adverse events, but filler injection-related adverse events in the HA and the PLA groups were reported in 2 cases (5.13%) and 5 cases (14.29%), respectively (P = .245). CLINICAL IMPLICATIONS: Our study provides an overview of clinical course after HA and PLA filler injections for PA and suggests that filler injections can be considered an alternative approach in patients with SPS. STRENGTHS & LIMITATIONS: Our study is the first to assess the psychological symptoms in patients with SPS who received the filler injection for PA; however, the follow-up duration was insufficient to prove the long-term outcomes of fillers. CONCLUSION: Without serious adverse events, HA and PLA filler injections for PA significantly resulted in not only an augmentative effect but also improvement of psychological distress, and the clinical utility was comparable between the fillers. Yang DY, Jeong HC, Ahn ST, et al. A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial. J Sex Med 2020;17:133-141.

Effect of udenafil administration on postmicturition dribbling in men: a prospective, multicenter, double-blind, placebo-controlled, randomized clinical study.

PURPOSE: Postmicturition dribbling (PMD) is a stressful symptom in middle-aged men characterized by urinary leakage after the completion of normal voiding. Appropriate treatments have not yet been introduced. This study assessed the efficacy of treatment of PMD with 75 mg udenafil daily. MATERIALS AND METHODS: The study included 138 men with regular sexual lifestyles. The Hallym PMD questionnaire (HPMDQ) was used to assess PMD symptoms. After all basic examinations, patients were randomly assigned to either udenafil or placebo. Patients completed the surveys, uroflowmetry (UFM), a bladder scan, and the paper test during the follow-up visit. RESULTS: The mean age of the patients was 57.6 years. PMD with one of every three urinations was experienced by 59 patients (42.8%), whereas 45 patients (32.6%) experienced PMD with two of every three urinations. PMD with every urination was experienced by 34 patients (24.6%). More than half of the patients (89 patients, 65.4%) indicated that persistent PMD symptoms would likely result in moderate to severe discomfort in their daily activities. As time passed, the udenafil group showed significant improvement in PMD symptoms (p = 0.001). CONCLUSION: Udenafil 75 mg once daily can be an effective treatment for patients with PMD symptoms.

CLINICAL OUTCOME OF POLYPOIDAL CHOROIDAL VASCULOPATHY/ANEURYSMAL TYPE 1 NEOVASCULARIZATION ACCORDING TO CHOROIDAL VASCULAR MORPHOLOGY.

PURPOSE: To determine the impact of choroidal vascular morphology on clinical outcomes in patients with polypoidal choroidal vasculopathy/aneurysmal Type 1 neovascularization. METHODS: Sixty-six eyes with polypoidal choroidal vasculopathy/aneurysmal Type 1 were included. Eyes were subdivided according to the choroidal vascular morphology of the large vessel layer on optical coherence tomography en face images: focal (n = 39) versus diffuse (n = 27) pachyvessels. All patients were treated with intravitreal ranibizumab pro re nata with or without rescue photodynamic therapy. RESULTS: Best-corrected visual acuity at baseline, 6, and 12 months did not differ between groups (P = 0.394, 0.142, and 0.292). At Month 3, best-corrected visual acuity was worse, and the proportion of eyes with fluid was higher in the focal group (P = 0.016 and 0.024). Among responders, the number of injections during 12-month follow-up was higher in the focal group (P = 0.033). During the total follow-up period, photodynamic therapy was required in 15 eyes (10 focal and 5 diffuse group, P = 0.497). The injection-free period after the photodynamic therapy was shorter in the focal group (P = 0.018). CONCLUSION: The polypoidal choroidal vasculopathy/aneurysmal Type 1 eyes with a diffuse pattern of pachyvessels required fewer injections during 12-month follow-up and showed a longer injection-free period after rescue photodynamic therapy.

Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebo-controlled trial.

OBJECTIVES: To compare the effects of taking tadalafil 5 mg and placebo once daily on post-micturition dribble (PMD) in men with lower urinary tract symptoms (LUTS). PATIENTS AND METHODS: Our prospective, randomized, double-blind, placebo-controlled, multicentre trial enrolled 102 men with PMD and other LUTS. PMD was assessed using the Hallym Post-Micturition Dribble Questionnaire (HPMDQ) and according to PMD volume. Over a 12-week period, patients took either tadalafil 5 mg (n = 51) or placebo (n = 51) once daily and their HPMDQ and PMD volume results were evaluated. Adverse events (AEs) were also reported. RESULTS: Over the course of 12 weeks, total HPMDQscores and PMD volumes improved significantly more in the tadalafil group than in the placebo group (reduction of total HPMDQ score of ≥2 points in the tadalafil and placebo group in 68.8% and 31.9% of patients (P < 0.001) and decreased mean PMD volume in the tadalafil and placebo group at 0.48 mL and 0.22  mL, respectively (P = 0.046). Specifically, PMD frequency decreased and quality of life increased significantly more in the tadalafil group than in the placebo group (P = 0.029 and P < 0.001, respectively). Furthermore, 66.7% of the tadalafil group reported moderate and significant PMD improvement, whereas only 4.2% reported that tadalafil was ineffective. Treatment-emergent AEs did not significantly differ between the groups (all P > 0.05), and no serious AEs were observed. CONCLUSION: Taking tadalafil 5 mg once daily reduced PMD symptom severity and PMD volume in men with PMD, without inducing serious AEs, more effectively than placebo, suggesting that taking tadalafil 5 mg once daily may be an effective and well-tolerated PMD treatment.

A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial.

BACKGROUND: Studies about the clinical utility of fillers on penile augmentation (PA) are lacking. Furthermore, no randomized study has compared the utilities of fillers. AIM: To compare the efficacy and safety between hyaluronic acid (HA) and polylactic acid (PLA) filler injection for PA. METHODS: This prospective, randomized patient/evaluator-blind, comparative multicenter study consisted of an initial 2-week baseline period and 48-week patient/evaluator-blind post-injection period. 72 patients with small penis syndrome were enrolled from 3 institutions between March-July 2016. Patients were divided into 2 groups: the HA group, comprising 36 patients injected with HA, and the PLA group, comprising 36 patients injected with PLA. MAIN OUTCOME MEASURES: Penile girth and satisfaction were assessed at baseline and at 4, 12, 24, and 48 weeks after injection. RESULTS: Penile girth increases adequately lasted ≤48 weeks in both groups (16.95 ± 10.53 and 13.49 ± 9.98 mm of mean increase in the HA and PLA groups, respectively; P < .001). The mean penile girth increase in the HA group was significantly greater than that in the PLA group at 4 weeks (P < .001). Subsequently, it gradually decreased and was no longer significantly different at 48 weeks (P = .075). Satisfaction levels increased after injection and were maintained ≤48 weeks. No significant differences were observed in the overall satisfaction level between the groups (P > .05). Filler injection-related adverse events were mild and transient and occurred in 1 and 3 patients in the HA and PLA groups, respectively. CLINICAL IMPLICATIONS: This study provides an overview of the efficacy and safety of HA and PLA fillers, which are the most commonly used soft tissue fillers for PA. STRENGTH AND LIMITATIONS: This study, to our knowledge, is the first to compare the efficacy and safety between different filler injections for human PA. However, it was impossible to perform a researcher-blinded trial because of the unique properties of fillers, and 31 patients (43.1%) were dropped during the study period. CONCLUSIONS: Both HA and PLA filler injections for PA led to a significant augmentative effect without serious adverse events and had clinically comparable efficacy and safety. Yang DY, Ko K, Lee SH, et al. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med 2019;16:577-585.

Retinoschisis in eyes with pachychoroid and retinal pigment epithelial atrophy.

PURPOSE: To describe the clinical characteristics and courses for eyes with retinoschisis associated with pachychoroid. METHODS: A retrospective interventional case series study. Twenty-one eyes (18 patients) with pachychoroid that showed retinoschisis without evidence of neovascularization that had been followed for 1 year were included. Multimodal imaging, including fundus photography, spectral-domain optical coherence tomography (OCT) with an enhanced depth protocol, fluorescein angiography (FA), and indocyanine green angiography (ICGA), was provided and treatment outcomes were analyzed. RESULTS: Focal RPE atrophy was present below or adjacent to the schisis in all eyes, and the mean atrophy area was 1.38 ± 1.37 mm2. Intraretinal fluids of the schisis originated from the atrophy area and involved the retinal layer which was correlated with the extent of outer retinal defect. Dilated Haller layer vessel and choroidal vascular hyperpermeability were observed under the area with atrophy in all eyes. After 1 year of treatment, 11 eyes (52%) still had fluid and 7 of them had fluid at the macula. Nonetheless, the mean central macular thickness decreased (144.4 to 121.8, P < 0.001), visual acuity improved (0.65 to 0.47, P = 0.026), and subfoveal choroidal thickness decreased (442.2 µm to 394.9 µm, P < 0.001). CONCLUSION: Atrophy of RPE can cause retinoschisis in eyes with pachychoroid. The intraretinal fluid that originated from underlying choroid and choroidal thickness decreased as intraretinal fluid diminished.

LONG-TERM PROGNOSTIC FACTORS FOR VISUAL IMPROVEMENT AFTER EPIRETINAL MEMBRANE REMOVAL.

PURPOSE: To identify prognostic factors that may predict the amount of long-term visual improvement after idiopathic epiretinal membrane removal. METHODS: A retrospective study of 114 patients who underwent epiretinal membrane removal was performed. The central foveal thickness, inner retinal layer thickness, inner retinal irregularity index, length of the cone outer segment tip line defect, and length of the ellipsoid zone defect were measured. The optical coherence tomography parameters that were associated with the amount of visual improvement were determined at 24 months postoperatively. RESULTS: Central foveal thickness and inner retinal irregularity index were not associated with best-corrected visual acuity at 24 months (P = 0.227 and P = 0.544, respectively), whereas the lengths of cone outer segment tip line defect and ellipsoid zone defect were associated with worse best-corrected visual acuity at 24 months (P = 0.015 and P < 0.001, respectively). Univariate regression analysis indicated that central foveal thickness and inner retinal irregularity index were associated with visual improvement (P = 0.011 and P < 0.001, respectively). Multivariate regression analysis indicated that inner retinal irregularity index, a marker of the inner retinal deformation, was associated with visual improvement after adjusting for age, gender, and other optical coherence tomography findings (P < 0.001). CONCLUSION: Patients with preoperative inner retinal deformation were found to have significantly improved long-term visual outcomes after epiretinal membrane removal.

CHOROIDAL MORPHOLOGY IN EYES WITH PERIPAPILLARY POLYPOIDAL CHOROIDAL VASCULOPATHY.

PURPOSE: This study analyzes a subset of patients with peripapillary polypoidal choroidal vasculopathy (PCV) to determine whether quantifiable pachychoroid features colocalize with disease foci. METHODS: Patients with PCV diagnosed by indocyanine green angiography were identified for the analysis of medical records and multimodal imaging and classified as having peripapillary or macular PCV. The ratio of Haller layer thickness to total choroidal thickness was calculated at the fovea and at the site of dilated Haller vessels that showed spatial correlation with the origin of neovascularization. Choroidal thickness was measured horizontally across the fovea and circumferentially around the temporal side of the disk to study its relationship to neovascularization. RESULTS: Three hundred and fourteen eyes of 299 patients with PCV were identified, of which 17 eyes (5%) had peripapillary disease. Although eyes with peripapillary PCV exhibited thinner subfoveal choroids than those with macular PCV, at the extrafoveal disease foci, choroidal thickness, Haller's layer thickness, and its ratio to total choroidal thickness were relatively high. CONCLUSION: Quantitative indices of choroidal structure previously identified in macular PCV performed consistently when applied to a peripapillary PCV cohort, thus supporting the hypothesis that inner choroidal thinning and Haller vessel enlargement are mechanistically relevant to these related entities.

FOCAL DISRUPTIONS IN ELLIPSOID ZONE AND INTERDIGITATION ZONE ON SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY IN PACHYCHOROID PIGMENT EPITHELIOPATHY.

PURPOSE: To describe a distinctive focal disruption of the ellipsoid zone (EZ)/interdigitation zone (IZ) determined by spectral-domain optical coherence tomography in eyes with pachychoroid pigment epitheliopathy. METHODS: Twenty patients with focal EZ/IZ disruptions associated with pachychoroid without history or findings indicative of subretinal fluid were evaluated. Detailed clinical/imaging characteristics and their longitudinal changes were evaluated. RESULTS: A total of 27 lesions from 21 eyes were included. The mean subfoveal choroidal thickness was 450 µm. In six of seven eyes with previous imaging data to compare, characteristic drusenoid lesions associated with thick choroid preceded focal EZ/IZ disruptions at the corresponding sites. Dilated outer choroidal vessels were noted beneath the focal EZ/IZ disruption in 24 lesions (88.9%), with attenuation of choriocapillaris in 18 lesions (66.7%). The external limiting membrane was intact in all lesions. All except three eyes did not show morphologic changes, and mean visual acuity was maintained (Snellen equivalent, 20/25) during a mean follow-up period of 20 months. CONCLUSION: Focal disruptions of the EZ/IZ band can develop in pachychoroid eyes in the absence of subretinal fluid, with a stable clinical course, and possibly as a result of regression of drusenoid lesions. This may represent an atrophic form of pachychoroid manifestation.

EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT AND RANIBIZUMAB IN ASIAN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Subgroup Analyses From the VIEW Trials.

PURPOSE: To assess the treatment effect of intravitreal aflibercept and ranibizumab in Asian patients with neovascular age-related macular degeneration. METHODS: We evaluated data from VIEW 1 and VIEW 2, comparing functional and morphologic outcomes at Week 96 between intravitreal aflibercept 2 mg monthly (2q4) or 2 mg bimonthly after 3 initial monthly doses (2q8) versus ranibizumab 0.5 mg monthly among Asian patients (n = 269) and between Asian and white patients (n = 2044). RESULTS: In Asian patients, there were no significant differences between intravitreal aflibercept 2q4 and 2q8 compared with ranibizumab in mean gain in best-corrected visual acuity (10.23 and 8.35 vs. 8.51 letters). Reduction in central retinal thickness was greater for intravitreal aflibercept 2q4 (150.43 µm, P = 0.0075) and 2q8 (148.15 µm, P = 0.0126) than ranibizumab (119.46 µm). The proportion of dry retinas was greater for intravitreal aflibercept 2q4 (65.7%, P < 0.01) than ranibizumab (41.7%). There were no differences in outcomes between Asian and white patients. Serious treatment-emergent ocular adverse events occurred in <8% of treated eyes, evenly distributed across subgroups. CONCLUSION: In Asian patients with neovascular age-related macular degeneration, functional and morphologic outcomes were largely similar between intravitreal aflibercept and ranibizumab groups, and to results seen in white patients.

Choroidal morphology under pachydrusen.

IMPORTANCE: To reveal choroidal morphological profiles under pachydrusen. BACKGROUND: Drusen in pachychoroid disorders show certain differences from conventional drusen and are recently named as "pachydrusen." This study analysed the specific choroidal morphology under pachydrusen. DESIGN: This study is a cross-sectional case series. PARTICIPANTS: Enrolled were 136 eyes with pachydrusen from 134 patients. METHODS: The presence of pachydrusen in fundus area covered by a 12 × 9 mm2 optical coherence tomography (OCT) image was accessed in eyes with pachychoroid-related diseases or their fellow eyes using colour fundus photography and swept source OCT. Choroidal morphology under the pachydrusen was analysed using OCT B-scans and en face images. MAIN OUTCOME MEASURES: Choroidal thicknesses and topographical correlation between pachydrusen and pachyvessels. RESULTS: A total of 225 pachydrusen in 136 eyes were analysed. The mean number of pachydrusen was 1.65 ± 1.07 per eye. Most pachydrusen were located para- or perifoveally (37 subfoveal, 86 parafoveal and 102 perifoveal). The proportion of Haller's layer to total choroidal thickness was higher at the area of the pachydrusen compared to the subfovea (0.881 ± 0.081 vs 0.765 ± 0.111, P < 0.001). In multimodal image analysis, 90.1% of pachydrusen identified using fundus photography and OCT B-scan were located at the area of a dilated Haller vessel (pachyvessel) seen on en face images. CONCLUSIONS AND RELEVANCE: Choroidal morphology under the pachydrusen showed increased Haller's layer thickness with an attenuated choriocapillaris layer, which is the hallmark of pachychoroid definition. Topographically, their locations correlated with the underlying pachyvessel.

Healthcare Utilization and Treatment Patterns in Diabetic Macular Edema in Korea: a Retrospective Chart Review.

BACKGROUND: Limited data exist on real-world treatment patterns for diabetic macular edema (DME) in Korea. In this study, we investigated DME treatment patterns from 2009 to 2014 and the impact of baseline treatment on healthcare resource utilization and visual acuity (VA) outcomes. METHODS: A retrospective cohort chart review of DME patients treated at 11 hospital ophthalmology clinics between January 1, 2012 and December 31, 2013 was conducted. We collected data on demographics, healthcare resource utilization (clinic visits, treatment visits, and visits for ocular investigations), distribution of DME treatments, and VA. RESULTS: Overall, 522 DME patients (men, 55.2%; mean age, 59 years; mean HbA1c [n = 209], 8.4%) with 842 DME eyes were evaluated. For all treatments, healthcare resource utilization was significantly higher during the first 6 months versus months 7-12, year 2, or year 3 (P ≤ 0.001), but was highest for patients whose first treatment was an anti-vascular endothelial growth factor (VEGF) treatment (visits/quarter; anti-VEGF, 1.9; corticosteroids, 1.7; laser, 1.4). Use of macular laser therapy decreased (44% to 8%), whereas use of anti-VEGF injections increased (44% to 69%) during the study period. However, VA improvement was not commensurate with healthcare resource utilization of anti-VEGF treatment (mean VA gain, 2.7 letters). CONCLUSION: A trend toward increasing use of intravitreal anti-VEGF injections for DME treatment was observed in Korea. However, the frequency of dosing and monitoring was lower in clinical practice versus major clinical trials, which may have led to the less-than-favorable improvements in visual outcomes.

Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management.

Polypoidal choroidal vasculopathy (PCV) is an age-related macular degeneration (AMD) subtype and is seen particularly in Asians. Previous studies have suggested disparity in response to intravitreal injections of anti-vascular endothelial growth factor (VEGF) agents between PCV and typical AMD, and thus, the preferred treatment for PCV has remained unclear. Recent research has provided novel insights into the pathogenesis of PCV, and imaging studies based on OCT suggest that PCV belongs to a spectrum of conditions characterized by pachychoroid, in which disturbance in the choroidal circulation seems to be central to its pathogenesis. Advances in imaging, including enhanced depth imaging, swept-source OCT, en face OCT, and OCT angiography, have facilitated the diagnosis of PCV. Importantly, 2 large, multicenter randomized clinical trials evaluating the safety and efficacy of anti-VEGF monotherapy and combination with photodynamic therapy (PDT) recently reported initial first-year outcomes, providing level I evidence to guide clinicians in choosing the most appropriate therapy for PCV. In this review, we summarize the latest updates in the epidemiologic features, pathogenesis, and advances in imaging and treatment trials, with a focus on the most recent key clinical trials. Finally, we propose current management guidelines and recommendations to help clinicians manage patients with PCV. Remaining gaps in current understanding of PCV, such as significance of polyp closure, high recurrence rate, and heterogeneity within PCV, are highlighted where further research is needed.

The transgluteal approach to shockwave lithotripsy to treat distal ureter stones: a prospective, randomized, and multicenter study.

PURPOSE: We compared the outcomes of SWL to treat distal ureter stones with regard to the conventional prone and supine positions using the transgluteal approach through the greater sciatic foramen. METHODS: A prospective, randomized, single-blind, and multicenter study was conducted between October 2014 and July 2015. The inclusion criteria were radio-opaque distal ureter stones with a maximum diameter of 0.5-2 cm as measured on a CT scan. The included 160 patients were randomly assigned to two groups: the prone group (n = 80; treated in the conventional prone position) and the transgluteal group (n = 80; treated in the supine position using a transgluteal approach). In the latter group, the focused shock wave was transmitted through the greater sciatic foramen with the head positioned at a 40° angle to the vertical. "Stone-free" was defined as the complete clearance of stone fragments, assessed using a CT scan at 2 weeks after treatment. Overall satisfaction was self-reported using a 0-5 Likert scale. RESULTS: The overall efficacy was 66.9%. The stone-free rate was significantly higher in the transgluteal group (72.6%) than in the prone group (54.7%; odds ratio 2.413, 95% CI 1.010-5.761, P = 0.023). No serious adverse events due to treatment were observed in either group. The satisfaction score of the transgluteal group was 4.21 ± 0.81, and 83.6% were willing to repeat the same procedure if necessary. CONCLUSIONS: SWL using the transgluteal approach via a supine position through the greater sciatic foramen was more effective than via the conventional prone position. Furthermore, this approach provided a comparably safe and satisfactory procedure.