Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma. TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient's home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months. The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences. NCT06682962.
Keen interest exists in the relationship between carotid atherosclerosis and primary open-angle glaucoma (POAG), with prior studies yielding inconsistent findings. This study aims to quantify the association between carotid intima-media thickness (CIMT) and POAG using data from a large cohort. In this cross-sectional analysis, we used data from 47 595 participants in the UK Biobank. CIMT was assessed using carotid ultrasound, while POAG was diagnosed based on health records and self-reported information. Logistic regression was used to detect CIMT-POAG association, after adjusting for potential confounders. Additionally, relationships with POAG-related endophenotypes, including intraocular pressure (IOP), macular retinal nerve fibre layer (mRNFL) thickness, macular ganglion cell-inner plexiform layer thickness and retinal vascular features, were examined through linear regression. A greater CIMT, evaluated per SD increment, was associated with a 10% increased risk of POAG (OR 1.10, p=0.004). The CIMT-POAG relationship exhibited an approximately linear pattern (p non-linear=0.797). This association was more pronounced in women (OR 1.18, p=0.003) and in individuals with a high genetic predisposition to POAG (OR 1.14, p=0.004). Furthermore, higher CIMT was significantly correlated with increased IOP (β=0.14, p=0.007) and decreased mRNFL thickness (β=-0.16, p=0.030). Additionally, higher CIMT was found to co-occur with retinal vascular impairments, including a decrease in fractal dimension, an increase in vessel tortuosity and a narrower central retinal arteriole (all false discovery rates<0.05). This study observes an association between increased CIMT and POAG, especially in women and individuals with genetic susceptibility. These findings suggest that CIMT may be a useful biomarker with potential clinical relevance and propose possible vascular mechanisms underlying disease progression.
To evaluate the performance of reasoning large language models (LLMs) with human-like thinking in ophthalmic question answering. We evaluated two state-of-the-art open-source reasoning LLMs (DeepSeek-R1 and QwQ-32B) and one conventional non-reasoning LLM (LLaMA-3.3-70B-Instruct) models on ophthalmology questions, assessing not only answer accuracy (ACC) but also the quality of their reasoning processes. First, we curated MedQA-Eye, a dataset of 967 ophthalmology questions across 10 subspecialties, 3 scenarios, 5 medical entities and 3 languages. Second, we proposed a novel framework considering human thinking patterns essential to medical practice to evaluate the thinking performance of reasoning LLMs on MedQA-Eye. DeepSeek-R1 demonstrated superior overall ACC (90.59%, 95% CI 88.59% to 92.27%) to LLaMA-3.3-70B-Instruct (87.90%, 95% CI 85.69% to 89.81%, p=0.015) and QwQ-32B (84.28%, 95% CI 81.85% to 86.44%, p<0.001) with performance varying across subspecialties. Analysis of reasoning LLMs revealed incorrect logical inference as the primary point of failure, accounting for 93.41%-94.74% of incorrectly answered questions. We further quantified semantic uncertainty in reasoning LLM thinking as a predictor of answer reliability. DeepSeek-R1 exhibited lower semantic uncertainty (1.04±3.63) compared with QwQ-32B (4.31±40.70), p<0.001. Reasoning LLMs demonstrated superior performance in ophthalmology question answering, with DeepSeek-R1 achieving the highest ACC. Our findings demonstrate that reasoning LLM can better simulate human-like thinking processes compared with conventional non-reasoning LLM, suggesting its potential for more trustworthy LLM systems in ophthalmology.
To investigate the association between visual impairment (VI) and all-cause mortality in older US adults and to examine the potential mediating roles of physical activity (PA) and depressive symptoms. This prospective cohort study included adults aged 60 years and older from the 2007 to 2008 National Health and Nutrition Examination Survey. VI was defined as either subjective visual impairment (SVI) based on self-reported vision status or objective visual impairment (OVI) defined as presenting visual acuity worse than 20/40 in the better-seeing eye. Cox proportional hazards models adjusted for demographic, anthropometric, socioeconomic and clinical covariates were used to examine the association between VI and all-cause mortality with propensity score matching and subgroup analyses. PA was assessed using a modified International Physical Activity Questionnaire and depressive symptoms were assessed using the 9-item Patient Health Questionnaire. Mediation analyses were performed to estimate direct and indirect effects through PA and depressive symptoms. A total of 2154 participants (mean (SD) age 70.6 (7.1) years; 44.2% male) were included. Over a median follow-up of 145.0 months, 399 (57.8%) deaths occurred in the VI group and 535 (34.6%) in the non-VI group. VI was associated with an increased risk of all-cause mortality after propensity score matching and multivariable adjustment (HR, 1.21; 95% CI 1.04 to 1.41; p=0.012). In subgroup analyses, SVI was significantly associated with mortality (HR, 1.33; 95% CI 1.13 to 1.57; p=0.001), whereas OVI was not. PA mediated 9.4% of the association between VI and all-cause mortality, whereas depressive symptoms did not. In this nationally representative cohort, VI was independently associated with higher all-cause mortality in older US adults. SVI appeared more predictive than OVI, possibly reflecting broader functional vision burden. Reduced PA partially mediated this association, whereas depressive symptoms did not. Residual confounding and measurement error cannot be excluded.
To assess the safety and tolerability of avacincaptad pegol (ACP), a Food and Drug Administration-approved therapy for geographic atrophy, administered in combination with ranibizumab, an approved therapy for neovascular age-related macular degeneration (nAMD), in patients with nAMD. The phase 1 study (NCT00709527) was a two-part, ascending-dose and parallel-group, open-label trial that assessed the safety, tolerability and pharmacokinetic profile of monthly intravitreal injections of ACP (0.03, 0.3, 1, 2, 3 mg) in combination with ranibizumab (0.5 mg) on the same day in treatment-naïve patients with nAMD (n=43 patients received a maximum of 6 injections). The phase 2a study (NCT03362190) was an open-label trial assessing the 6-month safety of intravitreal injections of ACP administered in combination with ranibizumab in treatment-naïve patients with nAMD (n=64). Patients received either ACP 2 mg or 4 mg either 14 days or 1 month apart, given on the same day or 2 days after ranibizumab. Primary outcome measures were safety and tolerability. During the phase 1 study, there were no dose-limiting toxicities at any dose level. In both studies, ocular treatment-emergent adverse events were mostly mild or moderate, with the most reported events related to the injection procedure. There were no clinically significant increases in intraocular pressure or cumulative increases with multiple injections over time. There were no safety issues identified through measurement of visual acuity. Coadministration of ACP and ranibizumab in treatment-naïve patients with nAMD was well tolerated across different dosing regimens with no new safety issues based on results from two independent studies.
To explore communication challenges in ophthalmic consultations from both patient and clinician perspectives, and to introduce 'Strategic Communication' as a structured, evidence-based approach aimed at enhancing patient-provider interactions and improving clinical outcomes. Multicentre mixed-method study involving online focus discussion groups and surveys. Eight ophthalmologists and eight patients recruited through the Italian national ophthalmic patient association participated in focus groups moderated by a health communication expert. These discussions explored communication challenges and potential solutions, based on participants' experience. Transcripts were thematically analysed by two independent researchers to identify key challenges and actionable insights. In parallel, quantitative data were collected via two structured questionnaires completed by 139 European ophthalmologists and 184 patients. Key themes included patients' limited understanding of their conditions, often influenced by misleading online information, and their strong preference for clear, empathetic communication. Clinicians reported that time constraints in public healthcare limited opportunities for meaningful dialogue, while the involvement of family members further complicated interactions. The 'Strategic Communication' framework, particularly the O.D.I. Method (Observe, Demand, Intervene), emerged as a structured framework for tailoring communication strategies to individual needs. 'Strategic Communication' offers a systematic, conceptual, theory-informed approach to address communication challenges in ophthalmology, with potential relevance for patient-centred care helping structured clinician-patient communication in ophthalmology. The present findings support its practical applicability. Future studies are needed to evaluate its impact on clinical and patient-reported outcomes.
Cataracts are the leading cause of poor vision in Japanese adults. As Japan's population is rapidly ageing, the demand for cataract surgery will continue to increase. Despite this, quantitative research evaluating both supply and demand of cataract surgery is lacking. The objective of this study was to forecast future cataract surgery demand and the supply of ophthalmologists in Japan by region and evaluate the cataract surgery demand-supply balance considering regional differences in demographics and medical resources. Based on the Ministry of Health, Labour and Welfare's 'NDB Open Data', age-specific and sex-specific cataract surgery rates were calculated from the number of billed procedures. These rates were applied to the Ministry of Internal Affairs and Communications' 'Population Estimates' and National Institute of Population and Social Security Research's 'Future Population Projections' to estimate demand for 2030, 2040 and 2050. Future supply of ophthalmologists was estimated using linear regression based on data from the 'Survey of Physicians, Dentists, and Pharmacists'. The demand-supply ratio (demand divided by supply) was calculated for each prefecture. The demand-supply ratio multiplier for each year was calculated using 2022 as the base year. The estimated number of cataract surgeries was 1 929 848 in 2030, 2 373 260 in 2040 and 2 863 733 in 2050, with a significant increase projected for individuals in their 70s and aged 80+. Although most prefectures were expected to see a gradual increase in ophthalmologist numbers, a decrease was projected for some regional areas. Consequently, the demand-supply ratio was projected to increase nationwide, with a larger increase in regional areas, suggesting a widening disparity between regional and metropolitan areas. Demand for cataract surgery would continue to rise, potentially increasing demand-supply imbalances, particularly in regions with ageing populations. Re-examination of the regional allocation of medical resources is necessary to correct disparities in access to treatment. These projections are subject to limitations related to the use of publicly available data and assumptions based on past trends, which may not fully reflect regional practice variation or future changes in surgical capacity.
In all countries, some population groups experience barriers to accessing eye health services, contributing to health inequities. Outreach is a common strategy used to deliver healthcare services to populations experiencing inequities. This scoping review aims to summarise the nature and extent of the existing literature describing outreach as a service delivery model to improve access to eye health services, particularly among populations experiencing inequities. An information specialist will search academic databases (Medline, Embase and Global Health) without language restrictions to find peer-reviewed articles describing outreach eye health services, published in any country between 1 January 2010 and the search date. Grey literature sources will also be searched. In Covidence, two reviewers will independently screen titles and abstracts and subsequently relevant full texts against the inclusion criteria. Data extraction will also be performed independently by two reviewers in Covidence. This scoping review will summarise the characteristics of the included outreach eye health services, including the type of eye health service delivered, personnel involved, mode of transport, source of funding and whether the service targeted any specific PROGRESS-Plus group (Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital, Plus). We will present our findings quantitatively using diagrams, tables and graphs. Ethics approval was not sought, as this scoping review will use only publicly available reports. The results of this review will be disseminated through publication in a peer-reviewed journal and will be presented at eye health conferences. It will offer valuable insights for eye health providers, health and social service providers and policymakers who are interested in improving access to eye health services for populations experiencing inequities. This scoping review will inform a project in New Zealand which aims to develop outreach eye health services to populations experiencing inequities, such as unhoused people and refugees. This protocol was registered on the Open Science Framework on 11 November 2025 (https://osf.io/vyz32).
We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment. A three-arm, parallel-group, open-label randomised feasibility trial. Tertiary neonatal intensive care in London, UK. We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (<-6.00 dioptres (D) or >±8.00D) were not included. Infants with retinopathy of prematurity were not excluded. At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses). Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term. Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant). We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study. ISRCTN14646770; NCT05048550.
This process evaluation explores patient and healthcare professional acceptability of community-based monitoring versus hospital-based care for patients with quiescent neovascular age-related macular degeneration (QnAMD). Qualitative process evaluation was conducted as part of a randomised controlled trial. Six hospitals and six community-based practices. 25 patients and 16 healthcare professionals (ophthalmologists and optometrists). This approach helped differentiate between common issues and those specific to community-based monitoring. The Quality-Assured Follow-Up of QnAMD by non-medical practitioners trial aimed to examine whether non-medical practitioners follow-up patients with QnAMD in the community in a safe and clinically and cost-effective way. The process evaluation aimed to examine whether the intervention was acceptable by patients and professionals. The process evaluation was based on interviews which contained open-ended questions focused on patient experience and confidence in community-based care, issues concerning the practicalities of the organisation and management of the clinic, and resources including IT and digital equipment. The theory of acceptability framework was used to interpret the findings. Patients reported positively on the experience of receiving QnAMD services in the community and highlighted staff professionalism and clear communication. Key themes were the proximity of care provision for patients, IT interoperability and the real-world costs of running the service. Some patients randomised to the hospital showed preference for the intervention to take place in the hospital, mediated mainly by prior experience of hospital care and travel distance. The location of the clinic and transport routes affected the experience of attending appointments, with strong preference expressed for proximity to one's home. Inaccessibility due to non-modifiable internal building structures in the community and parking in hospital eye services was reported by a small proportion of patients. Healthcare professionals reported positively about their ability to deliver QnAMD services in community settings but raised concerns about the compatibility of technological infrastructure that facilitates the sharing of optical coherence tomography image and video files. Some optometrists were also concerned about the financial sustainability of the intervention after the end of the trial due to the costs involved in the administration of QnAMD follow-up care. The delivery of QnAMD services in the community by non-medical personnel was broadly accepted by both patients and practitioners. This implies that non-medical practitioners can follow up patients with QnAMD in the community in a safe way. Further research would be needed to establish whether similar results would be obtained during routine practice outside a research project and whether the long-term follow-up for QnAMD would be financially sustainable for independent as well as chain community optometry practices. NCT03893474.
To compare the hazard of postoperative cystoid macular oedema (CME) between trabeculectomy and tube shunt implantation, focusing exclusively on non-diabetic patients to minimise confounding factors. This is a retrospective cohort study using the TriNetX United States Collaborative Network. Patients with glaucoma who underwent trabeculectomy or tube shunt surgery were identified via International Classification of Diseases, 10th Revision and Current Procedural Terminology codes. Propensity score matching (PSM) was used to balance baseline characteristics. The primary outcome was the hazard of CME at 1 and 3 months postoperatively. Adjusted HRs (aHRs) were calculated using Cox proportional hazards models. After 1:1 PSM, 2928 patients were included in each cohort. At 1 month, CME was significantly less frequent in the trabeculectomy group (1.15%) compared with the tube shunt group (1.85%) (p=0.02). This difference widened at 3 months, with CME rates of 2.19% in the trabeculectomy group vs 4.20% in the tube group (p<0.0001). Trabeculectomy was associated with a 35% reduction in CME hazard at 1 month (aHR: 0.64; 95% CI 0.44 to 0.94; p=0.023) and a 45% reduction at 3 months (aHR: 0.55; 95% CI 0.42 to 0.72; p<0.0001) compared with tube shunt surgery. Male sex (aHR: 1.32), topical alpha agonist use (aHR: 1.61) and macular puckering (aHR: 2.75) were independently associated with increased CME risk. Trabeculectomy is associated with a significantly lower hazard of postoperative CME compared with tube shunt surgery in non-diabetic glaucoma patients.
Chronic central serous chorioretinopathy (CSC) can cause progressive and permanent vision loss. Although photodynamic therapy (PDT) is a primary treatment option globally, it is not approved for CSC worldwide, limiting therapeutic access. The REPLAY trial is a phase III, investigator-initiated trial to evaluate the efficacy and safety of reduced-fluence PDT (rf-PDT) for chronic CSC to seek the first regulatory approval globally. This study comprises two cohorts. The 'untreated cohort' is a multicentre, randomised, placebo-controlled, double-masked trial involving 60 patients with untreated, fovea-involving chronic CSC, randomised 2:1 to receive a single rf-PDT or placebo treatment. The 'previously treated cohort' is a single-arm, open-label trial for up to 10 patients with recurrent CSC after PDT. The primary endpoint for both cohorts is the proportion of eyes with a complete resolution of subfoveal fluid at 12 weeks post-treatment, assessed by optical coherence tomography. Secondary endpoints include changes in best-corrected visual acuity, central choroidal thickness, recurrence rates and incidence of adverse events over a 48 week follow-up. The study protocol was approved by the Kyoto University Hospital Institutional Review Board, IRB of Chiba University Hospital, Tokyo Women's Medical University Institutional Review Board and Institutional Review Board of Kansai Medical University Hospital. Written informed consent is obtained from all participants. The results will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences. jRCT2051230156 (URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2051230156).
To investigate the impact of residual refraction within ±1.0 dioptre (D) on uncorrected distance visual acuity (UDVA) in pseudophakic eyes. Cross-sectional study. This study was based on retrospectively collected electronic refraction records from a tertiary care academic ophthalmology centre in southern China between May 2022 and July 2025. Patients aged ≥40 years who underwent uneventful phacoemulsification cataract surgery with in-the-bag monofocal intraocular lens implantation and achieved a postoperative corrected distance visual acuity (CDVA) of ≤0.1 logarithm of the minimum angle of resolution were enrolled. They were stratified by astigmatism subtypes: minimal astigmatism (<0.50 D), with-the-rule (WTR) astigmatism, against-the-rule (ATR) astigmatism and oblique astigmatism. Postoperative evaluation (≥1 month) included spherical equivalent (SE) refraction, UDVA and CDVA. UDVA was compared across eyes with SE intervals of 0.50 D within ±1.0 D. ORs were calculated to assess the relative risk of failing to achieve a UDVA of 0.1 or better for postoperative SE within ±1.0 D, using 0.00 D as the reference. The study included 1333 eyes from 1333 patients (mean (SD) age, 66.1 (8.96) years; 532 male (39.9%)). Overall, and particularly in the minimal astigmatism (<0.50 D), ATR astigmatism and oblique astigmatism subgroups, hyperopic eyes exhibited significantly better UDVA than their myopic counterparts. Slight myopia [-0.50 D, 0 D) significantly worsened UDVA versus 0 D in both the overall population and the minimal astigmatism subgroup. Slight hyperopia (0 D, +0.50 D] minimally affected UDVA, whereas an equivalent degree of myopia increased the odds of not achieving UDVA ≤0.1 by 1.55-fold (95% CI 1.08 to 2.21) overall and by 3.14-fold (95% CI 1.49 to 6.58) in the minimal astigmatism subgroup. Additionally, UDVA was optimal with minimal astigmatism and decreased progressively with each 0.50 D increment in residual astigmatism magnitude, a dose-dependent trend consistent across astigmatism subtypes. The impact of refractive errors (≤1.0 D) on UDVA was associated with the magnitude and type of astigmatism. Residual astigmatism of ≥0.50 D exerted a significant negative effect on UDVA. A plano SE (0 D) was optimal for minimum and WTR astigmatism, whereas slight hyperopia yielded superior UDVA in ATR and oblique astigmatism.
Aqueous humour (AH) contains relatively high concentrations of vitamin C (ascorbate). AH drains out of the anterior chamber through the trabecular meshwork (TM) and, therefore, TM cells in vivo are routinely bathed in this antioxidant. Yet, most TM cells are cultured in vitro in media without ascorbate. In this study, we investigated molecules expressed by TM cells cultured with and without ascorbate. Non-glaucomatous TM cell strains were grown to confluence and placed in serum-free media with or without 0.1 mM ascorbate for 3 days. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) and western blotting were used to investigate protein levels, and some bands were analysed by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) mass spectrometry. RNA was isolated and gene expression was quantified using fluorescent barcode technology. Following data normalisation, bioinformatics software was used to identify differentially expressed genes (DEGs). Quantitative PCR was used to validate results. In ascorbate-treated cells, western immunoblotting showed that several collagen chains were properly modified and secreted and LC-MS/MS identified proteins. Gene expression showed that 76 genes were significantly upregulated, and 20 genes were downregulated. Not surprisingly, antioxidative stress genes (SOD1, PRDX1, TXN2) were upregulated. Several genes involved in collagen synthesis, extracellular matrix assembly and remodelling (HSP47, MMP2, TIMP2, SERPINE1, CDH5, NCAM1, ITGA4) were also upregulated, but ITGB3 was downregulated. Genes involved with vascular endothelium growth factor (VEGF) (VEGFA, VEGFB), transforming growth factor β (SMAD2, SMAD4) and Hedgehog (PTCH1, GLI1) signalling pathways were also significantly altered by ascorbate treatment. Interestingly, many DEGs have no currently assigned role in ascorbate response. This study revealed several collagens and 96 genes that are regulated by ascorbate in TM cells. Our results establish the importance of including ascorbate in culture media during the in vitro culture of TM cells. Further analysis of the function of these genes may improve our understanding of the importance of ascorbate for TM cell health.
Evaluate the efficacy and safety of faricimab for treatment-naïve and pre-treated diabetic macular oedema (DME) in a real-world setting. This multicentre, retrospective cohort study examined consecutive DME patients treated with faricimab for ≥1 year. Data were collected at predefined time points. Primary outcomes were mean changes in corrected visual acuity (VA), centre-point retinal thickness (CRT) and central subfield thickness (CST) and treatment intervals and adverse events (AEs). 184 eyes with DME were included: 61 (33.2%) were treatment-naïve, and 123 (66.8%) were pretreated. In treatment-naïve eyes, VA improved from 69.7±15 Early Treatment of Diabetic Retinopathy Study letters at baseline to 73.9±14.1 after 12 months (p=0.014), while it remained stable in pretreated eyes (71.2±14.2 vs 73.0±12.9; p=0.14). CST decreased significantly in both groups (treatment-naïve (366.1±108.3 µm to 316.4±113.5 µm, p<0.001); pretreated (339.1±93.1 µm to 298.3±65.8 µm, p<0.001)). Thirty-one percent of naïve eyes and 21.1% of pretreated eyes were completely dry after 12 months. In treatment-naïve eyes, the mean treatment interval was 12.7±6.4 weeks at 12 months. In pretreated eyes, the interval increased from 6.0±3.0 to 7.8±3.6 weeks (p<0.001). Over 12 months, 8.1±2.1 and 9.4±2.5 injections were administered to naïve and pretreated eyes, respectively (p<0.001). Of the five recorded AEs, two cases of non-infectious intraocular inflammation and one cerebrovascular event were reported. Over 12 months, faricimab demonstrated good efficacy and safety in both treatment-naïve and pretreated eyes with DME. There was a reduction in CST and improved VA in treatment-naïve eyes and stable VA in pretreated eyes. The low number of AEs supports a favourable risk-benefit profile of faricimab in a real-world setting.
To evaluate the respective roles of systemic vascular vulnerability and local vascular anatomy in the onset of branch retinal vein occlusion (BRVO) by analysing the retinal age gap and arteriovenous crossing patterns. This observational study enrolled 202 patients with unilateral BRVO and 100 age-matched, sex-matched and axial length-matched healthy controls. A deep learning model was applied to colour fundus images to estimate the retinal age; the retinal age gap (predicted retinal age minus chronological age) in the fellow eye was used as a surrogate residual marker of systemic vascular vulnerability. At the occlusion site, arteriovenous crossing was classified (arterial vs venous overcrossing) using optical coherence tomography angiography (OCTA). The mean retinal age gap was 1.8±6.5 years and 0.2±6.0 years in the BRVO and control groups, respectively. Retinal age gap was significantly larger in BRVO eyes than in control eyes (p=0.046). A larger retinal age gap in the fellow eye correlated with younger age at BRVO onset (ρ= -0.350, p<0.001). Among 156 BRVO eyes with OCTA data, venous overcrossing at the occlusion site was more frequent in younger-onset major BRVO (p=0.031), whereas in macular BRVO, onset age did not differ by crossing pattern (p=0.734). Both systemic vascular vulnerability, reflected by a larger retinal age gap and local anatomical configuration, represented by venous overcrossing, may jointly contribute to BRVO susceptibility, particularly in younger patients. These findings should be interpreted with caution because the retinal age gap is a prediction, using a deep learning model, rather than a direct biological measure.
To develop a cloud-based software for analysing the disc-fovea angle (DFA) in fundus images using the stacking ensemble model and to evaluate the accuracy of the objective DFA assessment between automatic and manual analyses. A total of 682 fundus images (573 and 109 images of healthy individuals and patients with cyclotropia, respectively) were included in this retrospective study. For manual DFA analysis, two examiners analysed the DFA using web-based analysis software for the DFA, which was defined as the average value between the two examiners. For automatic DFA analysis, the stacking ensemble model on the cloud web integrated a single-shot multi-box detector to identify the fovea and centre of the optic nerve head, along with a single convolutional neural network combined with five machine learning algorithms. The DFA did not significantly vary between the automatic (7.25° ± 4.93°) and manual analyses (7.27° ± 5.07°) (p=0.52). The time required to analyse the DFA in a single fundus image was significantly shorter with the automatic analysis (0.430±0.240 s) than with the manual analysis (15.794±1.558 s) (p<0.001). These findings suggest that automatic analysis using the stacking ensemble model is useful for determining the DFA in clinical settings.
Neonatal survival continues to pose a global health challenge. Skin-to-skin contact (SSC) has been shown to significantly reduce neonatal mortality and offer numerous benefits for both mothers and newborns. However, its implementation varies widely across healthcare settings and is often hindered by practical barriers. This scoping review aims to systematically explore the facilitators and challenges associated with implementing SSC after birth and to synthesise relevant evidence to guide clinical practice. This scoping review will follow the Joanna Briggs Institute methodological framework for scoping studies. A comprehensive search will be conducted across seven electronic databases and grey literature sources. Two review authors will independently perform the screening of studies and data extraction in parallel. Discrepancies will be resolved through consensus or consultation with a third author. A data extraction form will be developed based on key themes related to SSC implementations. The extracted data will be qualitatively analysed and presented in diagrammatic, tabular and narrative summary forms, in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Reviews reporting guidelines. All data to be used in this study will be derived from previously published studies, thus rendering the need for ethical approval and informed consent superfluous REGISTRATION: This protocol has been registered in Open Science Framework (https://doi.org/10.17605/OSF.IO/CWPK4).
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Radiotherapy modalities such as iodine-125 (I125) and ruthenium-106 (Ru106) brachytherapy and proton beam radiotherapy (PBR) are well established for the treatment of choroidal melanoma. This study aimed to evaluate the rates of local tumour control, globe retention and visual acuity (VA) outcomes in patients with choroidal melanoma treated with I125 or Ru106 brachytherapy or PBR. A review was conducted of all cases of choroidal melanoma treated with Ru106 or I125 brachytherapy or PBR over a 10-year period. Patient demographics, comorbidities, tumour characteristics, treatment parameters and VA outcomes were analysed. A predictive nomogram was developed to estimate final VA based on baseline clinical, tumour and radiation parameters. A total of 310 eyes from 310 patients were included, comprising 175 patients (56.5%) treated with Ru106, 72 (23.2%) treated with I125 brachytherapy and 63 (20.3%) treated with PBR. Local tumour control was achieved in 95.8% of cases. The recurrence rates were 4.0%, 4.2% and 4.8% for Ru106, I125 and PBR, respectively. Retention rates were 96.0% for Ru106, 94.4% for I125 and 95.2% for PBR. LogMAR VA of 1.0 or better was maintained in 50.9% of Ru106patients, 27.8% of I125patients and 39.7% of those treated with PBR. Baseline LogMAR VA, tumour volume, radiation dose to the fovea, radiotherapy modality and follow-up duration were significant predictors of final VA and were incorporated into the nomogram. Each radiotherapy modality demonstrated high rates of local tumour control and globe retention. The predictive nomogram may serve as a practical tool to support individualised visual prognostication and patient counselling in the management of choroidal melanoma.