Japanese Journal of Ophthalmology最新文献

Purpose: To evaluate carotid cavernous fistula (CCF) ocular manifestations and outcomes and analyze predictors for clinical recovery within a 1-year follow-up period.

Study design: Retrospective cohort study.

Methods: Patients diagnosed with CCF were included. Clinical characteristics, visual acuity (VA), and intraocular pressure (IOP) were reviewed at baseline and at 1, 3, 6, and 12 months after treatment.

Results: Of the 141 eyes with CCF (133 patients), 45 and 96 were direct and indirect CCF, respectively. The most common ocular manifestations for both fistula types were dilated episcleral vessels (90.8%) and proptosis (75.9%). Embolization was performed in 43 (95.6%) and 51 (53.1%) eyes with direct and indirect CCF, respectively. The complete recovery rate from both CCFs at 1-year postembolization was 73.9%, whilst the recovery rate from the indirect type at 1-year postconservation was 21.2%. Factors predicting complete recovery included symptom duration of ≤30 days for direct CCF (adjusted odd ratio [aOR] = 7.77, P = .003) and embolization for indirect CCF (aOR = 3.63, P = .012). Overall, the VA significantly improved at 6 months after sole embolization (P <.05). Final good VA (≥20/40) and IOP (≤21 mm Hg) were attained in 64.0% and 96.9% of the cases, respectively. Initial VA of >20/200 (aOR = 38.78, P <.001) and age (aOR = 0.95, P <.001) were significantly associated with good final visual outcomes in both CCF types.

Conclusion: Patients with CCF required long-term follow-up of clinical recovery. Visual acuity at initial presentation and age should be considered for visual outcome prediction. Prompt diagnosis of direct fistula within 1 month and early embolization of indirect CCF can prevent residual symptoms following treatment.

Purpose: To compare visual function between pseudophakic eyes with enhanced monofocal intraocular lenses (IOLs) and phakic eyes with clear lenses among patients in their 50s, 60s, and 70s.

Study design: Prospective comparative study.

Methods: One hundred thirty-eight eyes with enhanced monofocal IOLs (enhanced monofocal group) and 117 phakic eyes with clear lenses (phakic group) among patients in their 50s-70s were enrolled. Distance-corrected visual acuity (VA) at various distances, and photopic and mesopic contrast VA were evaluated at 2 months postoperatively and compared between groups.

Results: In all age categories (50 s, 60 s, and 70 s), mean distance-corrected VA at the distances examined did not differ significantly between the enhanced monofocal and phakic groups. Mean contrast VA tended to be better in the enhanced monofocal group than in the phakic group. The difference was significant for photopic low contrast VA at 5% contrast in participants in their 50s (P = 0.002); mesopic contrast VA (P < 0.001) in participants in their 60s; and for photopic contrast VA at 10% and 5% contrasts and as well as mesopic contrast VA at 25% and 10% contrasts in participants in their 70s (P ≤ 0.003).

Conclusions: Among patients in their 50 s, 60 s, and 70 s, the accommodative range did not differ significantly between eyes with enhanced monofocal IOL and phakic eyes with clear lenses. Contrast sensitivity was generally better in eyes with enhanced monofocal IOLs than in phakic eyes, supporting the replacement of clear lenses with enhanced monofocal IOLs in patients of these ages with certain ocular pathologies.

Purpose: This study aimed to investigate differences in retinal blood flow leading to visual recovery in cases of macular detachment in rhegmatogenous retinal detachment (RRD).

Study design: Observational, retrospective case series.

Methods: We studied 64 eyes diagnosed with unilateral RRD with macular detachment that underwent pars plana vitrectomy from May 2010 to July 2015 at the Department of Ophthalmology, Nagasaki University Graduate School of Biomedical Sciences. We retrospectively measured visual acuity, blood pressure, intraocular pressure, and retinal blood flow using laser speckle flowgraphy (LSFG) preoperatively and at 1, 3, 6, and 12 months postoperatively.

Results: LogMAR visual acuity significantly improved one month after surgery (p<0.001. Friedman test with post-hoc test Bonferroni correction). The average mean blur rate (MBR) significantly improved three months after surgery compared to before surgery (95.9±26.0%, p<0.001). A significant correlation was observed between logMAR visual acuity and MBR changes at 1 month (r=- 0.42, p=0.007), 3 months (r=- 0.46, p=0.003), 12 months (r=- 0.32, p=0.03).

Conclusion: When vitrectomy is performed for RRD, the retina is repositioned, resulting in significant improvements in visual acuity and retinal blood flow.

Translational relevance: Visual acuity recovery is correlated with the recovery of retinal blood flow.

Purpose: The study aimed to develop and evaluate a deep learning-based program called the Hokkaido University pachychoroid index (HUPI) from choroidal imaging patterns of enhanced-depth-imaging optical coherence tomography (EDI-OCT) in central serous chorioretinopathy (CSC), to function as the representative indicator of pachychoroid spectrum diseases.

Study design: A single center, retrospective, observational study.

Methods: A modified LeNet was trained and validated using choroidal images (128 x 128 pixels) extracted from EDI-OCT images of representative 37 CSC and 40 normal eyes. The HUPI was then generated from the algorithm, ranging between 0 and 1 (1: the most pachychoroid-like feature). Choroidal images were used to prevent learning of SRF information. To evaluate discriminative ability, the area under the curve (AUC) of HUPI was compared to conventional choroidal indices using 69 acute CSC and 100 normal eyes. The HUPI of 69 acute CSC eyes, 35 convalescent CSC eyes, 86 fellow eyes of 104 patients diagnosed with CSC, and 100 normal eyes were calculated for comparison.

Results: HUPI showed a high ability to discriminate between acute CSC and normal eyes (AUC = 0.86), followed by the luminal to total choroidal area ratio (0.77), central choroidal thickness (0.76) and total choroidal area (0.75). The mean values of HUPI for normal, acute CSC, convalescent CSC, and CSC fellow eyes were 0.29±0.32, 0.77±0.28, 0.70±0.28 and 0.61±0.35, respectively. HUPI cut-off threshold was 0.66 with a sensitivity of 0.84 and a specificity of 0.77.

Conclusions: HUPI, a quantitative index of imaging patterns of pachychoroid, demonstrated a high ability to discriminate pachychoroid from normal eyes.

Purpose: In the pivotal PHOTON trial of patients with diabetic macular edema (DME), aflibercept 8 mg administered every 12 (8q12) and 16 (8q16) weeks demonstrated similar visual and anatomic outcomes with no new safety signals to aflibercept 2 mg every 8 weeks (2q8). We conducted a prespecified subgroup analysis to assess the efficacy, durability, and safety of aflibercept 8 mg in the Japanese patients from PHOTON.

Study design: Prespecified subgroup analysis of the Phase 3 PHOTON trial (NCT04429503).

Methods: Adult patients with DME were randomized 1:2:1 to receive intravitreal aflibercept 2q8, 8q12, or 8q16 following initial monthly doses. Patients randomized to 8q12 and 8q16 were eligible for dose regimen modification. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48. Prespecified efficacy and safety outcomes at/through Week 48 are reported, segmented by Japan versus the rest of world (non-Japan).

Results: In the Japan and non-Japan subgroups, respectively, mean changes in BCVA were +7.0 and +9.0 (8q12), +7.4 and +7.9 (8q16), and +8.0 and +9.4 (2q8) letters at Week 48; differences in least squares means were -0.30 and -0.64 letters between 8q12 and 2q8 and +0.17 and -1.76 letters between 8q16 and 2q8; ocular treatment-emergent adverse events were reported in 32.4% and 31.6% (8q12), 35.3% and 28.8% (8q16), and 30.0% and 27.2% (2q8) of patients.

Conclusion: Improvements in BCVA at Week 48 were generally similar with aflibercept 8 mg versus 2 mg in this subgroup analysis of Japanese and non-Japanese patients with DME, suggesting that the primary findings from PHOTON may be generalized to the Japanese population.

Purpose: To evaluate the 1-year efficacy and safety of aflibercept 8 mg compared with aflibercept 2 mg in a pre-specified analysis of patients from Japan with neovascular age-related macular degeneration (nAMD) included in PULSAR.

Study design: PULSAR (NCT04423718) was a global, phase 3, randomized, double-masked, non-inferiority study of adults with nAMD. Patients were randomized 1:1:1 to receive aflibercept 8 mg every 12 weeks (8q12), or every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups.

Methods: This subgroup analysis of Japan and non-Japan cohorts from PULSAR evaluated changes from baseline in best-corrected visual acuity (BCVA), central subfield retinal thickness, durability and safety outcomes.

Results: In the Japan subgroup, least squares (LS) mean (95% CI) changes from baseline in BCVA at week 48 were +6.5 (+0.7, +12.3), +7.9 (+5.1, +10.6), and +4.7 (-0.5, +9.9) letters for patients in the 8q12 (n = 31), 8q16 (n = 33), and 2q8 (n = 33) groups, respectively. The majority of patients in the 8q12 (82.1%) and 8q16 (93.8%) groups maintained their randomized dosing intervals through Week 48. Ocular treatment-emergent adverse events were reported in 35.5%, 30.3%, and 39.4% of patients in the Japan subgroup in 8q12, 8q16, and 2q8 groups, respectively. Similar efficacy and safety results were observed in the non-Japan subgroup.

Conclusion: Aflibercept 8 mg has similar efficacy and safety to aflibercept 2 mg when administered at extended dosing intervals in both the Japan and non-Japan subgroups, consistent with the overall PULSAR results.

Background: Focal choroidal excavation (FCE) is a rare chorioretinal abnormality with unclear pathophysiology. Identifying structural alterations in the choroid may provide insights into disease progression and potential therapeutic approaches. In this study, we aimed to evaluate fibrotic tissue within secondary FCE using polarization-sensitive optical coherence tomography (PS-OCT).

Cases: Two men (aged 73 and 74 years) with secondary FCE associated with macular neovascularization (MNV) and pachychoroid spectrum disease were included.

Observations: PS-OCT revealed distinct birefringence within the excavation area and adjacent choroid. The fibrous components showed multidirectional orientation, and in both cases fibrotic tissue was consistently observed at the excavation margins. A characteristic pattern of vertically aligned fibrous elements was identified, suggesting that fibrous tissue deposition plays a role in the structural remodeling process of secondary FCE.

Conclusions: PS-OCT enables detection of fibrotic remodeling in secondary FCE, offering new insights into its pathogenesis and clinical significance. Further studies are needed to clarify the clinical implications of these findings and their potential role in disease management.

Purpose: To investigate the clinical features and biomarkers associated with intraocular inflammation (IOI) following brolucizumab treatment in Asian switched neovascular age-related macular degeneration (nAMD) patients.

Study design: Multi-center, retrospective cohort study.

Methods: This study included 109 eyes from 93 nAMD patients switched from other anti-vascular endothelial growth factor (VEGF) agents to brolucizumab (Beovu) without loading. Baseline characteristics, IOI timing, initial symptoms, and risk factors were assessed.

Results: IOI was observed in 17 eyes from 14 patients, including anterior uveitis (AU, n = 7), intermediate uveitis (IU, n = 5), and panuveitis with or without retinal vasculitis (RV, n = 5). Two eyes were asymptomatic. The median duration for IOI onset was 26 days, with 11 of 17 eyes (82.4%) developing IOI before the third brolucizumab injection. Firth-penalized multivariate Cox regression analysis depicted that the total number of anti-VEGF injections within one year prior to brolucizumab initiation (HR = 1.4, p = 0.009) and retinal angiomatous proliferation (RAP) (HR = 10.9, p = 0.009), may be associated with IOI development. In contrast, baseline macular neovascularization (MNV) size and the presence of retinal pigment epithelial and outer retinal atrophy were not associated with IOI occurrence.

Conclusion: Vigilant examination after the initial brolucizumab injections is critical. Patients with identified risk factors may need meticulous monitor following brolucizumab injections.

Purpose: To compare real-world outcomes between first-generation iStent (G1) and iStent inject W (G2) combined with cataract surgery.

Study design: Retrospective, propensity score-matched clinical investigation.

Methods: Consecutive eyes treated with phaco-iStent (G1) or phaco-iStent inject W (G2) were matched 1:1 (n=115 per group) for age, preoperative intraocular pressure (IOP), medication score, axial length, and glaucoma subtype. Longitudinal changes in IOP and medication score were analyzed using linear mixed models. Surgical success was evaluated by Kaplan-Meier analysis under three prespecified criteria (A/B/C), and Cox models were used to estimate hazard ratios (HRs). Corneal endothelial cell density (ECD) and perioperative complications were recorded.

Results: The baseline characteristics were balanced after matching. IOP decreased significantly from baseline at all visits in both groups except G1 at 24 months; the time-averaged IOP during follow-up was lower in G2 than in G1 (Δ=0.46 mmHg; p=0.018). The medication scores decreased postoperatively in both groups. Kaplan-Meier survival did not differ between devices (log-rank p=0.59, 0.996, and 0.509 for criteria A, B, and C, respectively). Lower preoperative IOP was consistently associated with higher failure risk according to Cox models. The generation effect was not significant, although a nonsignificant trend toward greater G2 benefit at lower IOP was observed under criterion A. The perioperative complication rates were similar.

Conclusion: Both devices provided moderate reductions in IOP and medication burden with favorable safety. G2 achieved a statistically significant but small reduction in mean IOP over time, while the time-to-failure outcomes were comparable. Baseline IOP strongly influences success, underscoring the importance of patient selection.

Purpose: To evaluate real-world adherence to anti-vascular endothelial growth factor (VEGF) therapy among Japanese patients with diabetic macular edema (DME) and identify demographic, clinical, and socioeconomic factors associated with treatment discontinuation.

Study design: Retrospective, observational cohort study.

Methods: This study included 380 treatment-naïve patients with center-involved DME. Patients were categorized into continuation (those who maintained therapy) and self-discontinuation (those who discontinued therapy after at least one follow-up visit) groups. All patients were treated under a treat-and-extend regimen with one of five anti-VEGF agents (ranibizumab, aflibercept, brolucizumab, faricimab, or ranibizumab biosimilar) between January 2017 and December 2023. Univariate and multivariate logistic regression analyses identified independent predictors of treatment discontinuation. Pre- and post-treatment visual acuity and anatomic outcomes were assessed.

Results: Among 380 patients, 55 (14.5%) self-discontinued therapy. Younger age and poorer baseline best-corrected visual acuity were significantly associated with treatment discontinuation in both univariate and multivariate analyses. Furthermore, faricimab use increased the risk of discontinuation, whereas aflibercept use was associated with better adherence.

Conclusion: The findings of this study underscore the importance of individualized patient management strategies to enhance long-term adherence to anti-VEGF therapy among patients with DME.