Ophthalmology and Therapy最新文献

Introduction: Consensual ophthalmotonic reaction (COR) refers to consensual intraocular pressure (IOP) change in the fellow eye following alteration of IOP in one eye. The study aimed to investigate COR and the magnitude of consensual IOP change after unilateral glaucoma surgery.

Methods: We analyzed 356 eyes from 293 patients who underwent unilateral trabeculectomy, bleb needling, trabectome, or microcatheter-assisted trabeculectomy (MAT) between 2016 and 2022. In the fellow eye, baseline IOP was compared with IOP at 1 day, 1 week, 1 months, 3 months, and 6 months postoperatively. Fellow eyes with IOP change exceeding 4 mmHg or 20% increase from baseline were defined as fellow eyes with COR. Univariate and multivariate analysis were performed to identify influencing factors associated with COR and IOP change in the fellow eye.

Results: In fellow eyes, IOP was 18.3 ± 7.3 mmHg at baseline, significantly increasing to 19.3 ± 7.5 mmHg at postoperative day 1 (POD1) and remaining stable at other time points, with a COR incidence of 40.7% (145 eyes) at POD1. Univariate and multivariate analysis identified preoperative use of α₂-receptor agonists in the fellow eye as a significant protective factor against COR after trabeculectomy and bleb needling. We also identified that key influencing factors for COR varied by surgery type: pseudophakia in the fellow eye was protective in trabeculectomy, history of diabetes was a risk factor for bleb needling, and prior glaucoma surgery predicted COR after trabectome. Greater IOP reduction in the operated eye correlated with a larger consensual IOP rise following minimally invasive glaucoma surgery (MIGS) procedures.

Conclusions: Collectively, our findings suggest that COR is a common early postoperative phenomenon regardless of glaucoma surgery type, and the preoperative use of α₂-receptor agonists is associated with a lower incidence of COR. Therefore, it is essential to monitor IOP in the fellow eye perioperatively.

In this commentary paper, we discuss the potential of population health surveillance of retinal health in Denmark using optometrist-based opportunist retinal examination with tele-ophthalmology pathway. Using 12 months of data from 79 high-street optometrist stores, we imaged 355,818 unique individuals, which corresponds to 5.99% of the entire population of Denmark and equates to an average of 29,652 individuals each month, corresponding to 0.50% of the population. Coverage was highest among those aged 41-80 years, with coverage rates of between 8.17% and 8.68%. We also observed higher participation rates in female individuals (6.77%) than in male individuals (5.19%). Using Wilson score intervals with finite-population correction, we demonstrate that when such a large sample of the entire population is examined, prevalence estimates can be obtained with very narrow 95% confidence intervals. These results suggest that community imaging can provide stable, near real-time indicators of retinal disease at the population level. Selection bias is discussed to understand the limitations of data.

In 2011, meibomian gland dysfunction (MGD) was officially recognized as a condition that necessitated treatment with the goal of improving ocular symptoms. This was a tipping point in the understanding of MGD and the need for treatment. After 2011, there was an exponential increase in the research of MGD and treatment modalities. This commentary aims to provide information for clinicians to understand the value of in-office treatments with LipiFlow and the inherent differences in efficacy, patient/doctor experience, compliance, and safety of other treatment modalities. Also, the aim of this commentary is to describe how LipiFlow Thermal Pulsation System contributed to the evolution of MGD management by transforming therapeutic gland expression from an underutilized intervention into a widely adopted, evidence-based standard of care.

Introduction: This study aims to evaluate the efficacy, safety, and immunogenicity of ZRC-3285 (aflibercept biosimilar) with Eylea^® (aflibercept) in patients with neovascular (wet) age-related macular degeneration (nAMD).

Methods: This phase III, multicenter, double-blind study was conducted across 27 sites in India and randomized (2:1) patients with nAMD into either the test aflibercept (ZRC-3285, Zydus Lifesciences Ltd.) or Eylea^® (Regeneron Pharmaceuticals, Inc.) groups. All 184 enrolled patients (122 and 62 in the ZRC-3285 and Eylea^® groups, respectively) were included in the modified intend-to-treat (mITT) population. ZRC-3285 or Eylea^® was administered by intravitreal injection at a dose of 2 mg (0.05 mL) on days 1, 29, and 57. The primary objective was to assess non-inferiority of ZRC-3285 versus Eylea^® in treating nAMD and was evaluated by determining the proportion of patients who lose fewer than 15 letters from baseline visual acuity over 12 weeks using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Secondary objectives included comparison of additional efficacy outcomes, immunogenicity, and safety.

Results: Over 12 weeks, all patients in the ZRC-3285 (122, 100%) and Eylea^® (62, 100%) groups showed loss of fewer than 15 letters, demonstrating non-inferiority [95% confidence interval (CI) not evaluable (NE); p = NE)] of ZRC-3285 to Eylea^®. The proportion of patients who gained more than 15 letters in best corrected visual acuity (BCVA) over 12 weeks and the mean changes in BCVA, choroidal neovascularization (CNV), and central retinal thickness (CRT) were similar in both arms.

Conclusion: Efficacy, immunogenicity, and safety profiles of ZRC-3285 were found to be similar to those of Eylea^®.

Trial registration: Clinical trial Registry of India (CTRI): CTRI/2023/09/057655 [Registered on 14/09/2023].

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: This study investigated early anatomical and functional outcomes in patients with treatment-naïve neovascular age-related macular degeneration (nAMD) treated with 8 mg aflibercept compared to patients treated with the standard dose of 2 mg aflibercept using spectral domain optical coherence tomography (SD-OCT), microperimetry, and macular pigment optical density (MPOD) after loading phase administration.

Methods: This prospective, observational study included 30 eyes of 30 patients (mean age 70 ± 5 years; 15 male, 15 female) recruited between January and June 2025 at the Eye Clinic of the University of Naples "Federico II". Patients were assigned to one of two age- and gender-matched groups receiving intravitreal injections of aflibercept at the dose of 2 mg (group A) or 8 mg (group B). All patients underwent complete ophthalmological examination, SD-OCT, OCT angiography, microperimetry, fixation stability, and measurement of MPOD at baseline, month 2, and month 4.

Results: Group B showed an improvement in all parameters, compared to group A, in particular: a greater reduction in central macular thickness (CMT) (p = 0.008), an improvement in best-corrected visual acuity (BCVA) (p = 0.012), increased retinal sensitivity (p = 0.015), increased MPOD (p = 0.027), and reduced bivariate contour ellipse area (BCEA) (p = 0.039). Group B showed a faster drying rate during the first 2 months (70 vs. 40 μm/month) and overall at month 4.

Conclusions: Intravitreal injections of aflibercept 8 mg resulted in significant short-term anatomical and functional improvement compared to standard dose and thus appear to be an effective option to achieve faster results in nAMD. MPOD can be considered as a potential new biomarker of macular health to study retinal functional response.

Trial registration: The research protocol was registered on ClinicalTrials.gov (NCT07074054).

Introduction: Age-related cataracts are the leading cause of blindness worldwide, and phacoemulsification is the standard surgical treatment. Optical coherence tomography angiography (OCTA) enables non-invasive assessment of these microvascular changes. However, findings from individual studies remain inconsistent. This systematic review aimed to determine potential vascular changes in the macula and optic nerve using OCTA following phacoemulsification.

Methods: This review was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Three different databases-Scopus, PubMed and Web of Science-were searched for relevant studies published from 2015 to June 2025. Study quality was assessed using the Study Quality Assessment Tools developed by the National Heart, Lung, and Blood Institute (NHLBI). Among the identified studies, 21 were included in the review. All included studies assessed the changes in the retinal vascular network following phacoemulsification.

Results: The quality of most of the studies was moderate to high. Most studies reported an increase in vascular density in various vascular plexuses, though these changes varied by retinal region, vascular plexus, and follow-up duration. A reduction in the foveal avascular zone (FAZ) was also observed. These changes may be attributed to post-operative inflammation, decreased intraocular pressure (IOP) and increased retinal metabolism.

Conclusions: The results from this systematic review reveal that most included studies reported an increase in vascular density in various plexuses. These changes varied depending on retinal region, specific plexus, and follow-up duration. Additionally, a reduction in the FAZ was commonly observed. Patient-specific factors, such as diabetes and myopia, were associated with variability in vascular response.

Introduction: Rapid pathogen identification in severe infectious keratitis is critical for targeted therapy to prevent vision loss, but conventional methods are slow and only moderately sensitive. Our objective was to evaluate the diagnostic accuracy and turnaround time of combined FilmArray^® Meningitis-Encephalitis (ME)/Blood Culture Identification (BCID) multiplex polymerase chain reaction (PCR) panels versus standard microbiology (culture + pathogen-specific PCR) in severe infectious keratitis.

Methods: This was a prospective pilot diagnostic study at a French tertiary center (July 2023-April 2025) including 23 adults with severe microbial keratitis. Corneal samples were analyzed using both conventional microbiological testing (culture and pathogen-specific PCR) and rapid multiplex PCR with the FilmArray^® ME and BCID panels. Primary outcomes were diagnostic agreement between the FilmArray^® multiplex PCR system and conventional microbiological methods, measured by Cohen's κ coefficient. Turnaround times were compared using the Wilcoxon signed-rank test.

Results: Among 23 adult patients (mean age 61.0 [SD 21.2] years, range 24-99; 13 female patients [56.5%]), conventional microbiology identified pathogens in 16 cases (69.5%) versus 15 (65.2%) with multiplex PCR. Overall diagnostic agreement was moderate (κ = 0.50; 95% CI, 0.25-0.76), with perfect concordance (12/12, 100%) for monomicrobial infections detected by both methods. Multiplex PCR significantly reduced mean time to identification (2 h [no variation]) versus conventional methods (102 [SD 42.5] h; P < .001). Both methods were negative in six patients (26.1%) with comparable clinical severity.

Conclusion: Combined FilmArray^® ME/BCID panels demonstrated complete concordance with standard microbiology for monomicrobial keratitis and reduced turnaround times by > 100 h. This strategy may accelerate targeted therapy, potentially improving visual outcomes.

Introduction: Diabetic retinopathy (DR) is a leading cause of preventable blindness and is linked to excess mortality. Systemic inflammation plays a central role in DR pathogenesis, and the systemic immune-inflammation index (SII) has emerged as a novel marker associated with adverse outcomes. However, its prognostic value in DR remains unclear.

Methods: Using nationally representative data from National Health and Nutrition Examination Survey 2005-2018, we investigated the association between the systemic immune-inflammation index (SII) and all-cause mortality among 209 US adults aged ≥ 50 years with DR. Mortality status was ascertained through linkage to the National Death Index through 2019.

Results: Weighted Cox regression models showed that higher SII was modestly but significantly associated with increased mortality risk (HR = 1.01, 95% CI 1.00-1.002, p < 0.001), with restricted cubic splines indicating a non-linear relationship. SII exhibited moderate predictive ability for mortality, with AUCs declining from 0.762 at 24 months to 0.576 at 60 months. Subgroup analyses suggested that the association between SII and mortality persisted across most demographic and clinical strata.

Conclusion: These findings suggest that elevated systemic immune inflammation may independently predict long-term mortality risk in adults with DR, highlighting its potential value as a prognostic biomarker beyond traditional risk factors.

Introduction: This study aimed to analyze the influence of refractive status, residential climate, and exposure to adverse environmental factors in contact lens (CL) dropout.

Methods: This cross-sectional study involved a face-to-face survey conducted by trained optometrists among former and current CL wearers (CLWs) at General Óptica centers throughout Spain. The survey included questions related to demographic characteristics, refractive status, residential climate, and adverse environmental factors. The chi-square test and a forward stepwise binary logistic regression analysis were performed.

Results: A total of 1094 surveys were included, comprising 509 former CLWs and 585 current CLWs. Age (B = 0.03; OR 1.03, 95% CI 1.02-1.04) and exposure to chemical (B = 3.51; OR 41.67, 95% CI 12.06-143.95) or dusty environments (B = 1.05; OR 2.93, 95% CI 1.16-7.41) were significantly associated with CL dropout. However, residing in a continental climate was associated with a lower CL dropout compared with a Mediterranean climate (B = - 1.39; OR 0.25, 95% CI 0.15-0.42). Spherical refraction, cylindrical refraction, and near addition power did not show statistically significant associations with CL dropout. Furthermore, the model excluded sex, exposure to high-humidity or dry environments, and the interactions between adverse environmental factors and residential climate as predictive factors.

Conclusions: Older age, residence in the Mediterranean climate, and exposure to chemical or dusty environments increase the risk of contact lens dropout. However, climate-specific conditions do not appear to significantly influence dropout rates, suggesting that other factors may play a more important role.