Ophthalmology and Therapy最新文献

Introduction: Cataract surgery requires ophthalmic viscosurgical devices (OVDs) to stabilise the anterior chamber and protect the corneal endothelium during phacoemulsification. VISIOL, a viscoadaptive OVD containing sodium hyaluronate and mannitol, is designed to support safer surgical manoeuvres and minimise endothelial trauma. Contemporary real-world data on VISIOL remain limited. This post-market clinical follow-up prospectively evaluated VISIOL's performance and safety in routine cataract surgery in accordance with ISO 15798.

Methods: Adult patients undergoing phacoemulsification at Thai tertiary hospitals received VISIOL as a surgical aid at any stage. Intraocular pressure (IOP) and surgeons' evaluations were recorded during surgery. Corneal integrity, anterior chamber inflammation, IOP, and best-corrected visual acuity (BCVA) were determined preoperatively and at 1, 7, 30, and 90 days postoperatively.

Results: The study included 100 patients (mean age 67.4 ± 8.4 years) with severe cataracts (mean LOCS III nuclear opacity score 3.9 ± 1.4); 26% had glaucoma. Mean BCVA improved from logMAR 0.68 ± 0.69 before surgery to 0.088 ± 0.27 and 0.084 ± 0.24 after 1 and 3 months, respectively (p < 0.0001). Mean endothelial cell density change was -6.3% at 3 months (p < 0.0001). Anterior chamber inflammation progressively decreased to grade 0-1 in all cases at 1 month. IOP changes were nonsignificant (+0.4 ± 4.7 mmHg on day 1, p = 0.3378), with the occurrence of four transient IOP peaks ≥ 30 mmHg; all resolved within ≤ 1.5 h with or without treatment. Surgeons rated VISIOL as very effective for maintenance of anterior chamber depth during capsulorhexis (79%) and phacoemulsification (99%), and for the ease of capsulorhexis (98%) and removal (99%).

Conclusions: In patients with severe cataracts, including those with glaucoma, VISIOL demonstrated excellent safety, minimal complications, and favourable surgical outcomes.

Trial registration: The study was registered at ClinicalTrials.gov (registration number NCT04866706).

Introduction: This multicenter, longitudinal, observational real-world study evaluated the efficacy and safety of switching to intravitreal aflibercept 8 mg (Afl 8) in pretreated eyes with neovascular age-related macular degeneration (nAMD) within the Swiss Retina Research Network. A total of 283 eyes from 245 patients previously treated with other anti-vascular endothelial growth factor (anti-VEGF) agents (aflibercept 2 mg, faricimab, and ranibizumab) were included, with 1-year efficacy outcomes analyzed in 246 eyes and safety assessed in all treated eyes.

Methods: We recorded demographics, baseline functional and anatomical parameters-including spectacle-corrected visual acuity (VA) and optical coherence tomography (OCT) data-treatment history and outcomes over 12 months after switching to Afl 8. The main outcome measures were change in VA, central subfield thickness (CST), presence of intra- and subretinal fluid (IRF/SRF) and pigment epithelial detachment (PED), treatment intervals, and adverse events.

Results: Twelve months after the switch to Afl 8, mean VA remained stable, while mean CST decreased from 329.1 to 302.8 µm (p < 0.001). The portion of eyes without retinal fluid increased from 29.9% at baseline to 47.5% after 12 months. In parallel, the mean treatment interval was extended by 32.3% from 7.1 to 9.4 weeks (p < 0.001). At 1 year, 35.4% of eyes reached intervals of 8-11 weeks, while 20.2% achieved intervals of 12 weeks or longer. Intraocular inflammation was reported in 11 cases (3.9%).

Conclusions: In pretreated nAMD eyes with high treatment demand, switching to Afl 8 resulted in a significant anatomical improvement and longer treatment intervals in a majority of patients. These real-world results highlight the therapeutic potential of Afl 8, with no new or unexpected safety issues.

Introduction: This work aims to compare the 12-month changes in refractive outcomes, safety, efficacy, predictability, corneal biomechanics, and corneal topography between keratorefractive lenticule extraction (KLEx) and KLEx combined with prophylactic corneal collagen cross-linking (KLEx Xtra).

Methods: A prospective, randomized, controlled trial was conducted with 80 eyes in each group. The primary endpoint was the manifest refraction spherical equivalent (MRSE) at 12 months postoperatively in both groups. Secondary endpoints included visual outcomes, corneal biomechanical parameters, and topographic changes. The study has been registered at ClinicalTrials.gov (No. NCT06992011).

Results: At the 12-month follow-up, a small statistically significant difference in MRSE was observed between the two groups (KLEx Xtra: - 0.02 ± 0.38 D and - 0.17 ± 0.35 D, p = 0.047). Both groups demonstrated comparable and favorable safety and efficacy indices at 12 months. While corneal haze occurred universally early after the CXL procedure, it persisted in a subset of eyes for up to 6 months. At 12 months postoperatively, both KLEx and KLEx Xtra groups showed significant changes in corneal biomechanical parameters. The KLEx Xtra group exhibited enhanced biomechanical strength, with a significant improvement in parameters such as first applanation velocity (A1 V), Corvis biomechanical index (CBI), stiffness parameter at applanation 1 (SP-A1), and stress-strain index (SSI), compared to the KLEx group at 12 months postoperatively (p < 0.05). There were no significant differences between the two groups in corneal topographic parameters up to 6 months postoperatively, but at 12 months, the KLEx group showed significantly higher steep K value of anterior corneal surface (K2 F) compared to the KLEx Xtra group.

Conclusions: KLEx Xtra demonstrates superior refractive accuracy with a reduced risk of myopic regression within 12 months of follow-up while also enhancing corneal biomechanical strength, making it a viable alternative for people with high myopia.

Trial registration: The study has been registered at Clinicaltrials.gov, NCT06992011 (retrospectively registered at May 7, 2025).

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: Congenital dacryocystocele (CD) represents a rare yet clinically significant subtype of congenital nasolacrimal duct obstruction. It carries a substantial risk of severe secondary infection, yet its risk factors have not been fully elucidated. This study aimed to identify the independent risk factors for secondary infection in infants with CD and to evaluate the impact of infection on treatment course and prognosis.

Methods: A retrospective cohort study was conducted in 100 infants (118 eyes) diagnosed and treated for CD in a tertiary hospital between January 2017 and December 2024. Demographic characteristics, clinical features, and treatment details were collected and analyzed. Univariate analysis and a multivariate logistic regression model were used to identify independent risk factors associated with secondary infection.

Results: Secondary infection occurred in 60 of the 118 eyes (50.85%, 95% confidence interval (CI): 41.50-60.20%). Multivariate logistic regression analysis identified three independent risk factors for secondary infection: concomitant intranasal cyst (adjusted odds ratio (aOR) = 5.07, 95% CI: 2.10-12.23, p < 0.001), a history of lacrimal sac massage (aOR = 3.11, 95% CI: 1.29-7.46, p = 0.01), and disease onset during the winter-spring season (aOR = 2.97, 95% CI: 1.27-6.93, p = 0.01). Compared to the non-infected group, infants with secondary infection required a significantly longer treatment duration (median: 6.00 days vs.1.00 day, p < 0.001) and required more invasive management.

Conclusions: Concomitant intranasal cyst, a history of lacrimal sac massage, and winter-spring season onset are strong independent predictors of secondary infection in CD. Secondary infection is associated with not only a prolonged treatment course but also a higher probability of invasive intervention. These findings highlight the need for accurate diagnosis and adherence to standardized treatment protocols in infants with CD.

Artificial intelligence (AI) has emerged as a transformative force in ophthalmology, enabling automated, accurate, and efficient clinical reporting. This review summarizes recent advances in AI-driven report generation, emphasizing the integration of multimodal imaging and clinical data. Deep learning and natural language processing (NLP) models can synthesize information from diverse sources-including fundus photography, optical coherence tomography, fluorescein angiography, and patient records-to generate structured, interpretable, and personalized diagnostic reports. Such systems enhance diagnostic precision, streamline workflow, and reduce interobserver variability. We outline the technological foundations underlying these systems, including convolutional and transformer-based architectures, self-supervised and multimodal learning, and large language models. Representative applications in diabetic retinopathy, glaucoma, cataract, and age-related macular degeneration are discussed, highlighting their clinical value and emerging real-world deployment. Persistent challenges-including data heterogeneity, model interpretability, ethical governance, and clinical integration-are critically reviewed. Finally, we explore future directions such as real-time AI-assisted reporting, predictive and personalized analytics, and global scalability across healthcare ecosystems. Multimodal, explainable, and clinically integrated AI systems hold promise to redefine ophthalmic diagnostics and improve both clinician efficiency and patient outcomes.

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.

Introduction: This work aims to evaluate the real-world efficacy and safety of intravitreal faricimab over a 6-month follow-up period.

Methods: Data from 38 centers across Turkey were retrospectively analyzed between November 22, 2024, and May 4, 2025. Patients who received at least one intravitreal faricimab injection and had complete ophthalmic and optical coherence tomography (OCT) data with a minimum 1-month follow-up were included. Demographics, diagnosis, macular neovascularization (MNV) subtype, prior treatments, best-corrected visual acuity (BCVA-decimal/ETDRS), central macular thickness (CMT), intra/subretinal fluid, MNV size, injection number, follow-up duration, and ocular/systemic adverse events were recorded at baseline, at week 2, and at month 1 after the first injection, after three injections, and at the final visit.

Results: A total of 351 eyes from 316 patients were analyzed, including neovascular age-related macular degeneration (nAMD) (72.1%), diabetic macular edema (DME) (18.2%), retinal vein occlusion (RVO) (6.0%), and other MNV subtypes (3.7%). When comparing pre-treatment and final visits, naïve eyes showed a CMT reduction of 105.63 ± 114.89 µm (p < 0.001), while switch eyes had a CMT reduction of 86.58 ± 108.36 µm (p < 0.001). The total ETDRS letter gain from baseline to final visit was 16.3 ± 12.08 (p < 0.001) in naïve eyes and 8.3 ± 12.23 (p < 0.001) in switch eyes. Intraretinal and subretinal fluid rates significantly decreased (p < 0.001), and MNV area contracted on OCTA (p < 0.001). Only one mild, self-limited intraocular inflammation case (0.16%) occurred.

Conclusions: Faricimab demonstrated rapid and significant anatomical and functional improvements in 6-month real-world data, evident as early as 15 days after the initial injection, with a safety profile comparable to phase III trials. These findings support faricimab as a potent and reliable therapeutic option in the real-world management of nAMD and DME, though extended follow-up is needed to assess long-term outcomes.

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.

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.