Ophthalmology and Therapy最新文献

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: 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.

Introduction: Frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of neovascular age-related macular degeneration (nAMD) burden patients and healthcare systems. Faricimab may reduce this burden, but robust data are lacking. This study aimed to systematically quantify the injection frequency reduction with faricimab compared to anti-VEGF agents and estimate Dutch budget impact.

Methods: A systematic review of studies on patients with nAMD switching to faricimab was conducted in PubMed. A hybrid approach using artificial intelligence (NotebookLM) and manual verification was employed for data extraction and risk of bias assessment. A random-effects meta-analysis determined the pooled mean difference in annual injections. A budget impact analysis estimated direct medical costs (drug and administration costs) over a 1-year time horizon using Dutch data.

Results: A meta-analysis of 19 real-world studies (2231 patients) was conducted. Patients switched to faricimab for persistent fluid or to extend treatment intervals, resulting in a significant mean reduction of 2.65 injections in the first year (from 9.70 to 7.05; 95% confidence interval - 3.36 to - 1.93). The base-case analysis projected annual savings of approximately €79 million, corresponding to 96,235 fewer injections nationwide. Scenario analyses showed that substantial savings (€16 to €75 million) can be achieved when using faricimab in second- and third-line settings, although replacing first-line bevacizumab would increase costs.

Conclusions: Switching patients to faricimab reduced the injection frequency by two to three injections in the first year. Although evidence certainty was limited by statistical heterogeneity, the reduction was consistent across studies. Although replacing first-line bevacizumab increases costs, substantial savings are achievable in later lines. Strategic positioning of faricimab in the second-line yields significantly higher savings compared to third-line use, and could significantly lower the clinical, patient, and economic burden of nAMD care in the Netherlands. These findings provide quantified, real-world evidence to inform Dutch clinical practice and healthcare policy.

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: The Collaborative Normal-Tension Glaucoma Study (CNTGS) is frequently cited as evidence that a 30% reduction in intraocular pressure (IOP) slows progression in normal-tension glaucoma (NTG). This study re-examines the statistical methodology of CNTGS to assess how its conclusions are supported by the data.

Methods: This study reviews the CNTGS design with emphasis on survival analysis methodology, including the definition of time zero, censoring rules, and intention-to-treat (ITT) versus per-protocol comparisons. Particular attention is given to the post hoc redefinition of baseline and the handling of cataract-related visual decline, assessing their impact on the reported treatment effect.

Results: CNTGS shifted the analytical baseline for the treatment group to the point of IOP stabilization, thereby excluding early progression events and introducing immortal time bias. Additionally, cataract-related visual decline, more frequent in the treatment group, was censored rather than treated as a competing risk or time-dependent covariate. These methodological choices reduced the number of counted progression events in the treatment arm. Although the adjusted per-protocol analysis yielded a statistically significant treatment effect, this effect disappeared under the original ITT analysis, which included all randomized eyes from time zero and all progression events.

Conclusion: The potential treatment benefit reported in CNTGS depended largely on post hoc analytical modifications, whereas the original ITT analysis did not support a statistically significant effect of IOP reduction. These findings highlight the importance of transparent survival analysis methods and strict adherence to ITT principles in future NTG trials. Well-designed prospective studies that avoid immortal time bias and model treatment-related events appropriately are needed to clarify the true role of IOP reduction on NTG management.

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: Diabetic retinopathy (DR) often causes vision loss and functional impairment. Standard low vision rehabilitation improves visual function but many patients cannot access it because of cost, travel, and limited specialist availability. We aimed to compare a home-based digital vision rehabilitation program to standard in-clinic rehabilitation in patients with DR.

Methods: We conducted a retrospective matched cohort study at a tertiary eye center in China. Adults with moderate to severe visual impairment from DR were included. A total of 380 patients were analyzed after 1:1 propensity score matching (190 per group). One group underwent a 12-week home-based digital physiotherapeutic vision training program delivered via a mobile app with daily exercises and weekly telehealth supervision, while the other group received standard in-person low vision rehabilitation over 12 weeks. The primary outcome was change in visual functional status measured by the Veterans Affairs Low-Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48). Secondary outcomes included visual acuity, vision-related quality of life, depressive symptoms, mobility, metabolic control, and cost. Outcomes were assessed at baseline, 12, 24, and 48 weeks.

Results: Both the home-based digital training and standard in-clinic rehabilitation groups achieved substantial improvements in vision-specific functional status over 48 weeks. VFQ-48 scores increased by 22-26 points in each group, indicating clinically meaningful gains, and the digital program's improvement was comparable to standard care (demonstrating non-inferiority for the primary outcome). All secondary outcomes improved comparably in both groups, with no significant between-group differences. The digital intervention cost 7791 Chinese yuan (CNY) per patient over 48 weeks compared to 10,305 CNY with standard care, providing a net savings of 2514 CNY per patient. Both approaches were well tolerated, with no major safety concerns.

Conclusions: Home-based digital rehabilitation was non-inferior to standard in-clinic rehabilitation in improving functional vision, while substantially reducing costs and maintaining safety. These findings support implementing home-based or hybrid telerehabilitation models to broaden access to vision rehabilitation services.

Level of evidence: Level III retrospective cohort study.