Ophthalmology and Therapy最新文献

Introduction: The aim of this study was to investigate the magnitude and quadrantal distribution of angle kappa in patients with cataracts and high myopia (axial length ≥ 26 mm).

Methods: A total of 2485 patients with cataracts and high myopia and 354 patients with cataracts without high myopia (axial length < 26 mm) were included in this study. The location and value of angle kappa were determined using an Oculus Pentacam HR. An angle kappa distance exceeding 0.5 mm was defined as a large angle kappa distance.

Results: In high myopic eyes, multivariable linear regression analysis revealed that a larger angle kappa distance was significantly associated with longer axial length (standardized regression coefficient [β] = 0.24), narrower white-to-white (β =  -0.08), lower keratometry (β =  -0.08), higher corneal astigmatism (β = 0.06), and older age (β = 0.06) (all P < 0.01). The axial length cutoff point with the maximum Youden Index indicating the presence of a large angle kappa distance was 30 mm (area under the curve = 0.64). In high myopic eyes, the most common regions of angle kappa relative to the pupillary axis were the temporal-superior (40%) and temporal-inferior (26%) quadrants. However, in non-high myopic eyes, the most frequent regions were the nasal-superior (31%) and nasal-inferior (31%) quadrants.

Conclusions: An axial length of ≥ 30 mm is a risk factor for the presence of an angle kappa distance greater than 0.5 mm. In high myopic eyes, the most common location of angle kappa is the temporal-superior quadrant relative to the pupil center.

Purpose: Patients with diabetic retinopathy (DR) are at risk of visual deterioration owing to systemic and financial barriers in accessing appropriate care. DR screening tools that implement artificial intelligence (AI) algorithms are gaining recognition due to their accuracy and high-throughput potential. This systematic literature review aimed to understand the economic, humanistic, and clinical burden associated with delayed DR management and the impact of AI-based screening tools for diagnosis and treatment.

Methods: MEDLINE, Embase, and Cochrane Library databases were searched per Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (1 January 2014 to 28 October 2024). Screening, extraction, and quality assessment were performed by two independent reviewers. Supplementary searching was conducted to evaluate visual outcomes.

Results: In total, 33 records were included. Economic evidence demonstrated that infrequent screening was initially cost-saving but decreased patient quality-adjusted life years, delayed sight-threatening DR diagnosis, and resulted in high treatment-related costs in the long term. Several studies found delayed DR treatment to adversely impact visual acuity, central subfield thickness, and time spent with vision loss. The majority of economic studies evaluating AI-based screening found its use to result in lower overall costs than conventional screening, while two noted higher costs attributable to greater screening uptake and increased specialist referrals. Most studies that modeled clinical impact found AI-based screening to reduce blindness or vision loss versus conventional screening.

Conclusions: This research underscored the considerable harms associated with delayed DR diagnosis and treatment. AI-based screening tools have the potential to become powerful instruments in supporting improved clinical outcomes for patients and economic benefits for healthcare systems.

Introduction: Glaucoma remains a leading cause of adult blindness worldwide, highlighting the need for updated insights into contemporary first-line treatment patterns.

Methods: We conducted a retrospective cohort study using electronic health records from the TriNetX Global Collaborative Network (2013-2024). Patients aged ≥ 40 years with a diagnosis of open-angle glaucoma (OAG) or angle-closure glaucoma (ACG) were included. Monotonic trends in first-line glaucoma treatment were assessed over 12 years using Mann-Kendall tests, with Kendall's τ and a false discovery rate-adjusted P value (the Q value) reported. A positive τ indicated an increasing trend and a negative τ a decreasing trend. First-line treatments were classified into three categories: medication (single or combination therapy), surgery, and laser therapy.

Results: We included 322,910 patients with OAG and 40,119 patients with ACG. In OAG, the use of medication as initial therapy declined over time (91.0% in 2013, 87.7% in 2018, and 85.8% in 2024; τ = - 0.515, Q = 0.036), whereas surgery increased (4.8%, 7.9%, and 9.0%, respectively; τ = 0.606, Q = 0.021), and laser treatment remained stable (4.2%, 4.5%, and 5.2%; τ = 0.303, Q = 0.193). In ACG, medication use increased (72.4%, 79.3%, and 88.6%; τ = 0.818, Q < 0.001), while both surgery (9.8%, 5.3%, and 2.6%; τ = - 0.879, Q < 0.001) and laser therapy (17.8%, 15.4%, and 8.8%; τ = - 0.788, Q < 0.001) declined.

Conclusions: Medication therapy accounted for most first-line treatment in both OAG and ACG between 2013 and 2024. Over time, treatment patterns shifted toward greater use of surgery in OAG and increased reliance on medication in ACG. These trends highlight the need for future studies to evaluate long-term outcomes and inform subtype-specific glaucoma care.

Introduction: This study reports the 1-year efficacy of aflibercept 8 mg (afl8) in a real-world cohort of treatment-naïve patients with neovascular age-related macular degeneration (nAMD).

Methods: An observational, retrospective case series from nine centers of the Swiss Retina Research Network including treatment-naïve eyes with nAMD started on intravitreal afl8. Changes in visual acuity (VA), macular thickness, pigment epithelial detachment (PED) height, and retinal fluids were evaluated over 12 months and compared with baseline. Treatment intervals and safety data were recorded along with subgroup analyses based on macular neovascularization type, loading-phase completion, and treatment regimen.

Results: A total of 91 eyes met the inclusion criteria. After 1 year of treatment, VA changed by + 1.0 ± 13.2 letters (p = 0.018), mean CST changed by -110.0 ± 130.9 µm (p < 0.001), and mean PED height changed by -71.2 ± 104.8 µm (p < 0.001). After 12 months, 66.2% of eyes demonstrated a complete absence of macular fluids. Mean treatment interval was 13.9 ± 7.9 weeks, with 56.1% of eyes being extended to ≥ 12 weeks with an anatomy-driven approach. No functional or anatomical differences were observed between eyes receiving a clean loading phase and in terms of different macular neovascularization (MNV) subtypes. Two adverse events were observed.

Conclusions: The first 1-year real-world experience with afl8 in patients with nAMD revealed a robust anatomical response but only a variable and limited visual gain over 12 months due to a ceiling effect. Our findings confirm the fast and sustained macular drying reported from clinical trials, allowing for extended treatment intervals without compromising safety and efficacy.

Introduction: Recent advances in the development of antivascular endothelial growth factor (VEGF) therapy for neovascular age-related macular degeneration (nAMD) include the approval of aflibercept 8 mg, which delivers four times the previously commercially available dose. A longer durability of aflibercept 8 mg compared with 2 mg was reported in the clinical trial results. However, there are limited data in patients switching to aflibercept 8 mg from other agents in clinical practice. This study reports the initial real-world experience of consecutive patients switched to aflibercept 8 mg.

Methods: Consecutive eyes with previously treated nAMD receiving aflibercept 8 mg switched from other agents were retrospectively reviewed. Patients were switched either owing to suboptimal control of disease activity (efficacy group) or to potentially extend treatment intervals (durability group). The main outcome measures included change in optical coherence tomography (OCT)-based anatomical parameters, including central subfield thickness (CST) and presence of subretinal fluid (SRF), intraretinal fluid (IRF), and pigment epithelial detachment (PED) before and after switching. In addition, quantification of OCT biomarkers was performed using the RetinAI Discovery algorithm.

Results: A total of 30 eyes from 29 patients were identified. Among the 25 eyes in the efficacy group, 20 eyes remained on aflibercept 8 mg through to the last follow-up visit. Median CST showed a significant reduction from 291 (275-301) µm to 279 (269-289) µm (p = 0.02). Volumetric analysis showed a significant reduction in SRF volume, a small nonsignificant increase in IRF volume, and a trend toward reduction in PED volume. The five eyes in the durability group had no SRF, IRF, or hemorrhage at the time of switching and remained stable during the follow-up period.

Conclusions: These results provide early experience of aflibercept 8 mg in a clinical cohort in hard-to-treat patients. The current analysis demonstrated favorable anatomical outcomes after switching in most patients, with no safety signals.

Light is a major environmental signal that shapes circadian rhythms, mood regulation, and ocular growth through a network of non-visual photoreceptive pathways. Increasing evidence suggests that photic information, particularly as decoded by intrinsically photosensitive retinal ganglion cells (ipRGCs), converges on central circuits governing both affective states and refractive development. To integrate these cross-system interactions, we propose the conceptual framework of a "light-eye-brain axis," which outlines how environmental light cues are encoded by the retina and subsequently modulate neuroendocrine, autonomic, and inflammatory processes. Within this framework, mood disturbances may contribute to myopic progression through altered light-exposure behaviors, neurotransmitter imbalance, hypothalamic-pituitary-adrenal axis instability, and impaired neuroplasticity, whereas high myopia may increase vulnerability to anxiety or depressive symptoms through shared neural and immune pathways. Taken together, this integrative perspective highlights how light-dependent signaling shapes both emotional and refractive outcomes, and provides a conceptual foundation for future mechanistic studies as well as evidence-informed approaches to optimizing light exposure in the context of mood and visual health.

Introduction: This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).

Methods: Twenty-four subjects diagnosed with cataracts and mild-to-moderate primary open-angle glaucoma were consented at a single site in Honduras. Those with pathologies that could confound outcomes were excluded. All subjects were required to have responded to topical prostaglandin analogues. Medication washout was performed prior to intervention. One eye of each subject was sequentially assigned to one of three arms (75 μg, 150 μg, or 300 μg of bimatoprost pads). The product was delivered in-the-bag via a commercially available intraocular lens (IOL) inserter and did not modify the steps of standard phacoemulsification cataract surgery other than attachment of bimatoprost implants to the IOL. We report interim results through 36 months.

Results: Twenty-one of 24 enrollees (87.5%) were retained through 36 months. Through 24 months, all subjects achieved the primary endpoint of intraocular pressure (IOP) reduction > 20% from baseline without any additional glaucoma medications. By month 36, all but a single subject (95.2%, n = 20) remained drop-free with continued IOP reductions > 20% across all remaining subjects. Each treatment arm realized mean IOP reductions from 32.3% to 49.3% over 3 years of follow-up visits. There were no significant intergroup differences. All eyes had a final best-corrected distance visual acuity of 20/30 or better. There were no serious implant-related adverse events. The most common events were dry eye (21.7%), transient vision decrease (13.0%), and subconjunctival hemorrhage (8.7%). All implants remained in the capsular bag.

Conclusions: The first human study of a novel system that mounts bimatoprost-infused pads to a single-piece IOL suggests favorable safety and efficacy and does not require additional surgical skills beyond routine cataract surgery. A larger sample with comparative data is necessary to further assess effects.

Trial registration: ClinicalTrials.gov identifiers, NCT07154797 and NCT07154810. Retrospectively registered on September 3, 2025.

Introduction: This study aimed to evaluate the efficacy and safety of Eyluxvi, an aflibercept biosimilar, compared with reference Eylea in patients with neovascular age-related macular degeneration (nAMD).

Methods: This phase 3, multicenter, randomized, double-masked, parallel-group study enrolled 431 patients at 79 sites across 12 countries. Patients were randomized 1:1 to receive intravitreal Eyluxvi or Eylea (2 mg) every 4 weeks through week 12, then every 8 weeks through week 48. The primary endpoint was change from baseline in best corrected visual acuity (BCVA) at week 8.

Results: The week 8 least-squares mean BCVA change was 5.771 letters with Eyluxvi vs 7.863 letters with Eylea (difference - 2.092 [95% confidence interval (CI) - 3.431 to - 0.753]). This equivalence was maintained through week 52. Week 52 adjusted mean changes were comparable for central subfield thickness (CST) (difference - 4.742 μm [95% CI - 22.006 to 12.521]) and choroidal neovascularization (CNV) area (difference 0.233 mm² [95% CI - 0.724 to 1.191]). Safety profiles and immunogenicity were similar between groups.

Conclusion: This study demonstrated therapeutic equivalence between Eyluxvi and Eylea in nAMD treatment, with comparable anatomical outcomes and safety profiles. These findings support the development of Eyluxvi as an aflibercept biosimilar, potentially increasing treatment accessibility for patients with nAMD.

Trial registration: EudraCT Identifier 2021-004530-11.

Background: Diabetic retinopathy (DR) remains a leading cause of preventable blindness, yet screening programs across Europe face persistent workforce and capacity constraints amid rising diabetes prevalence. Artificial intelligence (AI)-enabled screening platforms have been developed to support scalable DR detection; however, their regulatory status, validation approaches, and implementation readiness vary considerably.

Methods: We conducted a targeted scoping review of 13 CE-certified AI systems for autonomous or semi-autonomous DR detection available in the European Union as of October 23, 2025 (IDx-DR, EyeArt, RetCAD, Mona DR, Retmarker DR, SELENA+, Remidio Medios AI, RetinoScan, Aireen DR, OphthAI, LuxIA, Airdoc-Eye DR, and Vistel). Data were charted across predefined domains, including device designation, regulatory classification, evidence sources, validation study design, reported diagnostic performance metrics, and implementation-related considerations. The review aimed to map the extent and nature of available evidence without conducting quantitative synthesis or comparative ranking.

Results: Most systems employed deep-learning-based fundus image analysis, often incorporating automated image-quality assessment. Reported sensitivities and specificities for referable DR (RDR) varied across systems, generally falling within ranges consistent with regulatory expectations; however, reporting standards and study designs were heterogeneous, limiting direct comparison. Several systems were supported by multicenter or prospective evaluations, while others relied primarily on retrospective datasets. A subset of platforms reported multi-disease detection capabilities. Evidence specific to sight-threatening DR (STDR) was less frequently described and demonstrated wider variability. Non-EU regulatory pathways were mentioned in some reports, but were outside the primary scope of this review. Other systems demonstrate high diagnostic accuracy in controlled evaluations, though performance for STDR remains limited (mean ≈ 80%), largely due to reliance on single-modality 2D fundus imaging without optical coherence tomography (OCT) integration. Implementation-related evidence, including workflow integration and monitoring requirements under the EU Medical Device Regulation (MDR), was limited across systems.

Conclusions: CE-certified AI systems for DR detection represent a diverse and rapidly evolving landscape. While substantial progress has been made in regulatory classification and validation efforts, evidence remains heterogeneous, particularly for STDR detection and real-world implementation. Future research should prioritize consistent reporting standards, evaluation of multimodal approaches, and studies addressing real-world effectiveness to support safe and equitable deployment under the evolving EU regulatory framework.

Introduction: To evaluate the early outcomes of aflibercept 8 mg (afl8) treatment in patients with neovascular age-related macular degeneration (nAMD) previously treated with aflibercept 2 mg (afl2).

Methods: A retrospective, observational, monocentric Swiss study. Patients with nAMD who had received ≥ 3 consecutive afl2 injections and switched to afl8 because of persistent or recurrent fluids, or to extend treatment intervals, were included in the study. All patients started a loading phase of 3-monthly afl8 injections, followed by a treat-and-extend regimen. Outcome measures included changes in best-corrected visual acuity (BCVA), maximal pigment epithelial detachment (PED) height, central subfield thickness (CST), optical coherence tomography (OCT) biomarkers quantified using artificial intelligence, and treatment intervals until month 6.

Results: Fifty-two eyes of 44 patients who concluded the loading phase were included in this analysis. Mean age was 80.2 ± 8.5 years; 73% of patients were females. At month 6, BCVA was unchanged, PED and CST height experienced a significant decrease by - 18.5 ± 12.9 μm (p = 0.0005) and - 14.0 ± 3.5 μm (p = 0.0042), respectively. Volumes of intraretinal fluid (IRF), subretinal fluid (SRF), and PED decreased (IRF: 4.4 ± 15.6-3.8 nl; SRF: 15.7 ± 35.7-10.3 ± 34.0 nl; PED: 268.2 ± 423.2-252.2 ± 484.1 nl). Mean treatment intervals increased by 1.7 ± 0.5 weeks from the last assigned interval and by 0.6 ± 0.2 weeks from previous maximal fluid-free intervals after switching (p = 0.0005 and p = 0.18, respectively). One mild vitritis was observed and resolved with vitrectomy and topical drops without decreased visual acuity.

Conclusion: Our real-world study supports the potential short-term benefits of afl8 in improving anatomical and durability outcomes in patients with recurrent nAMD. These findings also highlight the added value of data-driven evaluations. Long-term studies are needed to confirm the effectiveness and durability of afl8 in this population.