To develop item banks for a patient-reported outcome measure (PROM) specific to vitreous floaters using input from patients. We report on the content generation and item refinement, and compare the content of the newly-developed PROM with published literature. Potential PROM items (questions) were identified from two sources: 20 existing floaters-specific PROMs and two qualitative studies in patients with floaters. This initial item pool was evaluated with binning (grouping) and winnowing (reduction) to group the PROM items into quality-of-life domains. Patients with floaters provided feedback on the pilot PROM item banks in cognitive interviews. The Dutch PROM item banks were translated into English, Arabic and Turkish. Each step was guided by an expert panel consensus. The initial item pool with potential PROM items consisted of 921 items. After three rounds of binning and winnowing, the item pool was reduced to 272 items. After 10 cognitive interviews, 19 items were changed, 8 were deleted and 8 were added. The final PROM item pool consists of 272 items across 12 item banks (quality-of-life domains): visual symptoms, ocular symptoms, general symptoms, activity limitations, driving, mobility issues, health concerns, economic impact, emotional well-being, social well-being, inconvenience and coping. The new floaters-specific PROM item banks included all 81 items from previous PROMs, supplemented with additional quality-of-life issues reported by people experiencing floaters (70.2%). The largest quality-of-life domains were 'health concerns' and 'inconvenience', emphasising the disease burden of experiencing vitreous floaters and patients' information needs. Item banking allows clinicians and researchers to choose what domains and items to use in their measurement. Additional quality-of-life issues identified in previously unstudied populations can be added and calibrated with the existing items. Future studies using the item banks can compare the quality-of-life impact of different clinical subgroups, and control for important confounders.

AimTo 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.MethodsThis 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.ResultsAfter 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.ConclusionsTrabeculectomy is associated with a significantly lower hazard of postoperative CME compared with tube shunt surgery in non-diabetic glaucoma patients.

In retrocaruncular medial decompression, the incision is small relative to the depth of the surgical space, and haemorrhage may obscure vision. Measures that minimise bleeding are most important to improve visualisation and facilitate the procedure. Despite this, there is no consensus regarding the effect of nasal packing with a vasoconstrictive agent. The aim of this study was to see if haemorrhage during external medial decompression could be reduced by nasal packing. A randomised, non-blinded, prospective study in which patients listed for orbital medial wall decompression at St Erik Eye Hospital, Sweden, were recruited. Patients were randomised to receive either nasal packing with a 4%+0.02% Cocaine Hydrochloride-Adrenaline solution or the control group. Intraoperative bleeding was quantified by weighing the suction device before and after the procedure. A total of 46 medial orbital wall decompressions in 37 patients were included in the final analysis. The treatment group, which received nasal packing, demonstrated significantly reduced intraoperative bleeding compared with the control group (median 9.40 g vs 30.10 g, p<0.001). No surgical complications or postoperative infections were reported. This study demonstrated a highly significant reduction in perioperative bleeding during retrocaruncular medial decompression when nasal packing with a vasoconstrictive agent was used (p<0.001). The main limitation of this study is the potential variability between surgeons. However, a post hoc test (p=0.75) and interaction analysis (p=0.63) did not reveal any differences between surgeons. In summary, nasal packing with a potent vasoconstrictor offers a simple, effective means to reduce intraoperative bleeding during external medial wall decompression and can thereby be an easy way to facilitate this surgical procedure and reduce the risk of complications.

ObjectiveRadiotherapy 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.Methods and analysisA 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.ResultsA 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.ConclusionsEach 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.

Biosimilars are helping to reduce the cost burden of treatment and widen patient access to therapies. This multicentre trial compared the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration (nAMD). Patients aged ≥50 years with newly diagnosed nAMD and a best-corrected visual acuity (BCVA) between 20/40 and 20/200 Snellen equivalent were randomised (1:1) to double-masked treatment with 2 mg FYB203 or EU-approved reference aflibercept by intravitreal injection every 4 weeks for three doses (baseline, weeks 4 and 8) then every 8 weeks up to week 48. The primary efficacy endpoint was the change from baseline in BCVA by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 in the study eye. Therapeutic equivalence of FYB203 and reference aflibercept was demonstrated if, depending on the regulatory requirement with respect to the significance level, the two-sided 90.4% and 95.2% CIs were within the predefined equivalence interval of (-3.5 to 3.5) ETDRS letters. A total of 433 patients received treatment with FYB203 (n=215) or reference aflibercept (n=218). Mean improvement in BCVA from baseline to week 8 was 6.6 ETDRS letters with FYB203 and 5.6 ETDRS letters with reference aflibercept, with an estimated mean treatment difference of 1.0 and the two-sided 90.4% CI (-0.3 to 2.2) and 95.2% CI (-0.6 to 2.5) fully contained within the pre-defined equivalence margins, confirming therapeutic equivalence between FYB203 and reference aflibercept. Safety and immunogenicity profiles were similar between groups. Although conducted during the COVID-19 pandemic in a potentially vulnerable elderly population and affected by geopolitical disruption in Ukraine, mitigation measures minimised the overall impact of these events. FYB203 demonstrated therapeutic equivalence to reference aflibercept in patients with nAMD, supporting similar clinical performance across all approved indications. Clinicaltrials.gov: NCT04522167; EudraCT: 2019-003923-39.

Introduction Dry eye disease (DED) is a multifactorial condition affecting up to 14.

PurposeTo analyse drug-associated immune-mediated uveitis (IMU) risk using large-scale pharmacovigilance data.MethodsWe conducted a retrospective pharmacovigilance study using data from the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases, encompassing reports from Q1 2004 to Q4 2024. Disproportionality analysis identified drug-IMU associations using reporting odds ratios (ROR) and information component (IC). Time-to-onset (TTO) was also assessed.ResultsDisproportionality analysis identified 17 176 IMU cases in FAERS and 2580 in JADER. IMU prevalence was higher in females, with the 30–80 age group most affected. Antineoplastic and immunomodulating agents, sensory organ drugs and anti-infectives were the most frequently associated drug classes with IMU. Among 117 drugs with positive signals for IMU in FAERS, brolucizumab (ROR025=145.89, IC025=7.08), faricimab (ROR025=134.06, IC025=6.97) and rifabutin (ROR025=82.23, IC025=6.32) exhibited the strongest associations. The three drugs also ranked as the top three drugs with the strongest association with IMU in JADER. The study also highlights significant differences in TTO among various drug classes, with musculoskeletal and sensory organ drugs showing longer TTO compared with other categories.ConclusionsOur study highlights the diverse range of drugs implicated in the occurrence or progression of IMU. These findings emphasise the need for early risk assessment, careful monitoring and positive intervention in managing treatments involving high-risk drugs. Future research should focus on elucidating underlying mechanisms and risk factors to develop safer therapeutic strategies.

PurposeContinuous curvilinear capsulorhexis (CCC) quality affects posterior capsule opacification and visual outcomes after cataract surgery. We developed a novel metric, the Capsulotomy Proficiency Index (CPI), to objectively evaluate the CCC manipulation during cataract surgery.MethodsWe developed a self-design code using MATLAB software to outline the motion trail of the capsulorhexis forceps, the surgical field motion amplitude, the CCC profile (circularity, deviation, decentration), the number of grasps and the total and effective CCC operating time, etc. Considering the weight of each parameter, an integrated CPI value was used to evaluate each CCC surgical video. A Mann-Whitney U test was used to compare the mean CPI from the two groups.ResultsThis study included two surgeons with different total cataract surgery volumes (group A: a surgeon with experience of less than 500 cases, group B: a surgeon with experience of more than 1000 cases). 15 CCC videos from each surgeon during the same working period were randomly selected. Group A demonstrated a significantly lower CPI mean value than group B (0.47±0.32 and 0.89±0.23), indicating a significant difference in surgical level.ConclusionsBased on the objective CCC surgical video evaluation, the CPI could reflect the surgical level difference in CCC manipulation.

PurposeObservational studies suggest that anxiety and depression disorders have significant correlation, but these results may have been influenced by confounding factors, and negative emotions that do not meet the criteria for clinical mental disease diagnosis are more common, the evidence for this association is unclear. This study employed whole-genome linkage disequilibrium score regression (LDSC), Mendelian randomisation (MR), Bayesian colocalisation (colocalisation) to explore association between common negative emotions and glaucoma.DesignBidirectional genetic associations between negative emotion and glaucoma.ParticipantsData from UK Biobank and FinnGen R10.MethodsMR, whole-genome LDSC, Bayesian colocalisation.Main outcome measuresGenetic causal associations between negative emotion and glaucoma.ResultAt Bonferroni-corrected levels of significance, there was no genetic correlation, causal association or shared genetic mechanism between any negative emotions and glaucoma, except for depression, which showed a genetic link but no causal evidence.ConclusionsDepression, anxiety and eight other common negative emotions may not be causally associated with glaucoma and there may be no genetic correlation between them.

ObjectiveTo evaluate the effectiveness of administering additional intravitreal topotecan injections (plus two) in reducing the recurrence rate in patients with advanced retinoblastoma (RB).Methods and analysisThis retrospective, non-comparative and interventional study encompassed 26 eyes of 25 patients with RB, treated between January 2019 and April 2024. All eyes in this series had received previous intravenous chemotherapy and/or intra-arterial chemotherapy. Patients received intravitreal topotecan (30 µg/0.1 mL) and/or intravitreal melphalan (20–30 µg/0.1 mL) injections every 3–4 weeks until vitreous seeds regression was achieved. Subsequently, two additional injections of topotecan (30 µg/0.1 mL) were administered after complete regression to consolidate subclinical residuals. The control of vitreous seeds, ocular toxicity assessment and clinical characteristics was observed.ResultsThe median age of the patients was 26 months, with 57.7% belonging to group D and 42.3% to group E of RB classification. A total of 111 injections were administered in 26 eyes, with a median of 4 injections per eye. Complete vitreous seeds regression was achieved in 100% of eyes, and eye salvage was successful in 24 of 26 eyes (92.3%). There were no recurrences of vitreous seeds. Enucleation was performed in two eyes: one due to phthisis bulbi and one due to optic nerve tumour recurrence. No cases of systemic metastasis or death were reported.ConclusionAdministering additional intravitreal topotecan injections (plus two) following the complete regression of vitreous seeds may contribute to reducing the recurrence rate in patients with RB. This approach enhances the long-term efficacy of intravitreal injections, thereby contributing to higher eye salvage rates.However, the retrospective, non-randomised design and small sample size remain limitations. Multicentre prospective studies are warranted to validate these findings and refine treatment protocols.