Aspergillus serology and clinical outcomes in patients with bronchiectasis: data from the European Bronchiectasis Registry (EMBARC).

INTRODUCTION: Aspergillus sp. cause diverse clinical manifestations in bronchiectasis including Allergic bronchopulmonary aspergillosis (ABPA), Aspergillus sensitization (AS) and raised IgG indicating exposure or infection with Aspergillus. RESEARCH QUESTION: What is the prevalence and clinical significance of Aspergillus-associated conditions in individuals with bronchiectasis? METHODS: Bronchiectasis patients enrolled into the EMBARC registry from 2015 to 2022 with laboratory testing for Aspergillus lung disease (total IgE, specific IgE to Aspergillus or Aspergillus skin test, IgG to Aspergillus and blood eosinophil counts) were included for analysis. Modified-ISHAM-ABPA working group criteria (2021) were used to define ABPA. RESULTS: 9953 patients were included. 608 (6.1%) were classified as having ABPA, 570 (5.7%) showed Aspergillus sensitization, 806 (8.1%) had raised Aspergillus-specific IgG without sensitisation, 184 (1.8%) were both sensitised to Aspergillus and had raised Aspergillus-specific IgG and 619 (6.2%) had eosinophilic bronchiectasis (elevated eosinophil counts without evidence of Aspergillus lung disease). The remaining 72.0% had negative Aspergillus serology. Patients with ABPA, Aspergillus sensitization, and raised Aspergillus-specific IgG had more severe disease, with worse lung function and more frequent exacerbations at baseline. During long-term follow-up, patients with raised Aspergillus-specific IgG had higher exacerbation frequency and more severe exacerbations. Aspergillus sensitization associated with increased exacerbations and hospitalisations only in patients not receiving inhaled corticosteroids. INTERPRETATION: Aspergillus lung disease is common in bronchiectasis. Raised IgG to Aspergillus is associated with significantly worse outcomes while ABPA and Aspergillus sensitization are associated with severe disease and exacerbations with a risk that is attenuated by inhaled corticosteroid use.

Induction avelumab followed by chemoimmunotherapy and maintenance versus chemotherapy alone as first-line therapy in cis-ineligible metastatic urothelial carcinoma (INDUCOMAIN): a randomized phase II study.

BACKGROUND: Platinum-based chemotherapy (ChT) has been the standard first-line treatment for metastatic urothelial carcinoma (mUC). The purpose of this study was to evaluate the use of induction avelumab followed by avelumab in combination with carboplatin-gemcitabine (carbo/gem) followed by avelumab maintenance. We tested the hypothesis that induction immunotherapy (IO) could enhance the response to ChT and prevent its detrimental effect on immune cells. MATERIALS AND METHODS: INDUCOMAIN is a multicenter, randomized, investigator-initiated, open-label phase II study evaluating the safety and efficacy of induction avelumab before carboplatin-gemcitabine-avelumab, followed by avelumab maintenance (arm A), compared to carbo/gem (arm B). Eligibility criteria included patients with mUC, no prior systemic therapy, and ineligibility for cisplatin by Galsky criteria. Patients were stratified by the presence/absence of visceral metastasis and Eastern Cooperative Oncology Group performance status 0-1 versus 2. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Eighty-five patients were included and randomized to arm A (n = 42) and arm B (n = 43), respectively. ORR was similar between treatment arms: 59.5% in arm A and 53.5% in arm B (P = 0.57). Fourteen patients (33%) in arm A early progressed/died before or at first response assessment, compared to three patients (7%) in arm B. Median OS was 11.1 months in arm A and 13.2 months in arm B [hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.57-1.46, P = 0.69]. Median PFS was 6.9 months in arm A versus 7.4 months in arm B (HR 0.99, 95% CI 0.61-1.60, P = 0.95). Treatment-related adverse events of grade 3-4 occurred in 70.7% of patients in arm A and in 72.1% in arm B. No predictive role of programmed death-ligand 1 expression was found. CONCLUSIONS: The hypothesis that induction avelumab could enhance the efficacy of subsequent ChT was not proven. Administering IO alone as induction before ChT is not an adequate strategy.

Reconciling moral discourses on choice, risk and pronatalism: the politics of elective egg freezing in Singapore.

This article examines the framing of choice, risk and pronatalism in Singapore's debate on elective egg freezing, beginning from the government's review of the ban in 2012 and ending in 2023 when the procedure was legalised. It demonstrates the possibility of reconciling liberal discourses on reproductive choice with technocritical discourses on egg freezing as a risky and oppressive pronatalist technology. While medical complications, false hope and commercial abuse were longstanding concerns in Singapore, these risks were perceived as reconcilable with choice through an age limit, mandatory counselling and comparative frames from the national and international regulatory context. Additionally, low fertility rates and efforts to advance gender equality enabled the reconciliation of choice and pronatalism as policy justifications, while the construction of female candidates' heteronormative reproductive desire framed pronatalism in women-centric ways. Such reconciliation was facilitated by Singapore's strong interventionist culture which normalises paternalism and pronatalism. Within this context and through actors' articulation of policy ideas, elective egg freezing was reinterpreted as a technology with manageable risks, and a hope technology for women and nation. A moral Singapore State which permits elective egg freezing while supporting the interests of women and society was thus co-produced by politicians, journalists and doctors.

Red flags for clinical suspicion of eosinophilic granulomatosis with polyangiitis (EGPA).

BACKGROUND: Eosinophilic granulomatosis with polyangiitis (EGPA), is a rare ANCA-associated systemic vasculitis. Its overlapping features with other vasculitic or eosinophilic diseases, and the wide and heterogeneous range of clinical manifestations, often result in a delay to diagnosis. OBJECTIVE: To identify red flags that raise a suspicion of EGPA to prompt diagnostic testing and to present an evidence-based clinical checklist tool for use in routine clinical practice. METHODS: Systematic literature review and expert consensus to identify a list of red flags based on clinical judgement. GRADE applied to generate a strength of recommendation for each red flag and to develop a checklist tool. RESULTS: 86 studies were included. 40 red flags were identified as relevant to raise a suspicion of EGPA and assessed by the experts as being clinically significant. Experts agreed that a diagnosis of EGPA should be considered in a patient aged ≥6 years with a blood eosinophil level >1000 cells/µL if untreated and >500 cells/µL if previously treated with any medication likely to have altered the blood eosinophil count. The presence of asthma and/or nasal polyposis should reinforce a suspicion of EGPA. Red flags of asthma, lung infiltrates, pericarditis, cardiomyopathy, polyneuropathy, biopsy with inflammatory eosinophilic infiltrates, palpable purpura, digital ischaemia and ANCA positivity, usually anti-myeloperoxidase, among others, were identified. CONCLUSION: The identification of a comprehensive set of red flags could be used to raise a suspicion of EGPA in patients with eosinophilia, providing clinicians with an evidence-based checklist tool that can be integrated into their practice.

Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure.

AIMS: Hypertonic saline solution (HSS) plus intravenous (IV) loop diuretic appears to enhance the diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this therapy in the ambulatory setting have not been evaluated. We aimed to describe the design and baseline characteristics of the SALT-HF trial participants. METHODS AND RESULTS: 'Efficacy of Saline Hypertonic Therapy in Ambulatory Patients with HF' (SALT-HF) trial was a multicenter, double-blinded, and randomized study involving ambulatory patients who experienced worsening heart failure (WHF) without criteria for hospitalization. Enrolled patients had to present at least two signs of volume overload, use ≥ 80 mg of oral furosemide daily, and have elevated natriuretic peptides. Patients were randomized 1:1 to treatment with a 1-h infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-h infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose). Clinical, laboratory, and imaging parameters were collected at baseline and after 7 days, and a telephone visit was planned after 30 days. The primary endpoint was 3-h diuresis after treatment started. Secondary endpoints included (a) 7-day changes in congestion data, (b) 7-day changes in kidney function and electrolytes, (c) 30-day clinical events (need of IV diuretic, HF hospitalization, cardiovascular mortality, all-cause mortality or HF-hospitalization). RESULTS: A total of 167 participants [median age, 81 years; interquartile range (IQR), 73-87, 30.5% females] were randomized across 13 sites between December 2020 and March 2023. Half of the participants (n = 82) had an ejection fraction >50%. Most patients showed a high burden of comorbidities, with a median Charlson index of 3 (IQR: 2-4). Common co-morbidities included diabetes mellitus (41%, n = 69), atrial fibrillation (80%, n = 134), and chronic kidney disease (64%, n = 107). Patients exhibited a poor functional NYHA class (69% presenting NYHA III) and several signs of congestion. The mean composite congestion score was 4.3 (standard deviation: 1.7). Ninety per cent of the patients (n = 151) presented oedema and jugular engorgement, and 71% (n = 118) showed lung B lines assessed by ultrasound. Median inferior vena cava diameter was 23 mm, (IQR: 21-25), and plasmatic levels of N-terminal-pro-B-type natriuretic peptide (NTproBNP) and antigen carbohydrate 125 (CA125) were increased (median NT-proBNP 4969 pg/mL, IQR: 2508-9328; median CA125 46 U/L, IQR: 20-114). CONCLUSIONS: SALT-HF trial randomized 167 ambulatory patients with WHF and will determine whether an infusion of hypertonic saline therapy plus furosemide increases diuresis and improves decongestion compared to equivalent furosemide administration alone.

Multidisciplinary radio-guided surgery team: Alternative to change the current paradigm.

INTRODUCTION: Given the constant increase in the healthcare demand for examinations related to radio-guided surgery (RGS), our hospital adopted new professional profiles in the RGS team, in order to partially reduce the time spent by nuclear medicine physicians on this task. AIM: To analyze the process of incorporating the profiles of Diagnostic Imaging Technician (DIT) and Sentinel Node Referent Nurse (SNRN), evaluating their deployment in the procedures linked to the technique. MATERIAL AND METHODS: Analysis of RGS activity during the period 2018-2022, focusing on pre-surgical and surgical procedures related to breast cancer (BC) and malignant melanoma (MM), as they are those pathologies on which the transfer of care competencies was concentrated. Chronological evolution of the competencies assumed by the different profiles during their integration into the RGS team. RESULTS: RGS's healthcare activity during the analyzed period experienced an increase of 109%. BC and MM were the pathologies that accounted for by far the greatest demand for care. The transfer of competencies in these two pathologies occurred in a progressive and staggered manner, with 74% (460/622) of the administration phase being carried out by the SNRN and 64% (333/519) of the surgeries by the DIT in 2022. CONCLUSIONS: The creation of a multidisciplinary RGS team that includes different professional profiles (nuclear medicine physician [MN], ERGC and TSID) is an effective strategy to respond to the increase in the complexity and number of all procedures related to RGS.

The Association Between Intra-abdominal Pressure and Diuretic Response in Heart Failure.

PURPOSE OF THE REVIEW: An efficient diuretic response is vital during cardiac decompensation in heart failure (HF) patients. The increase in intra-abdominal pressure (IAP) could be one of the keys for understanding cardiorenal syndrome and guiding diuretic treatment during hospitalization. In this review, we analyze the relationship between IAP and diuretic response in HF patients. RECENT FINDINGS: Increased IAP is associated with worsening renal function (WRF) in patients with advanced HF. Furthermore, the persistence of a rise in IAP after the first 72 h of intravenous diuretic treatment has been correlated with a worse diuretic response, a higher degree of congestion, and an impaired prognosis. The rise in IAP in HF patients has been associated with impaired renal function and a lower diuretic response. Nonetheless, more studies are needed to elucidate the actual role of IAP in congestive nephropathy and whether it may help guide diuretic therapy during acute decompensations.

The Value of Age-Friendly Public Health Systems in the Age-Friendly Ecosystem.

The United States population is living longer and healthier than ever. This enables our communities-and our society-to continue to benefit from our knowledge, experience, and energy as we age. The public health system is foundational for increasing life expectancy, and now it has the opportunity to further support older adult health and well-being. Trust for America's Health (TFAH), in partnership with The John A. Hartford Foundation, launched the age-friendly public health systems initiative in 2017 with the goal of raising awareness within the public health sector of its many potential roles in healthy aging. TFAH has worked with state and local departments of health to build capacity and expertise in older adult health and has provided guidance and technical assistance to expand this work across the U.S. TFAH now envisions a public health system that has healthy aging as a core function. This paper aims to describe why the public health sector should adopt healthy aging policies and practices, how this is being operationalized at the state and local levels, and the value of age-friendly public health systems within the age-friendly ecosystem.

Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes.

BACKGROUND: Among 96 million U.S. adults with prediabetes, adoption of evidence-based treatment to prevent diabetes remains low. Primary care represents an essential venue for preventing diabetes, yet providers in this setting have limited time to address prevention. This highlights the need for low-touch interventions that promote diabetes prevention and are not delivered by primary care providers. Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not been definitively studied for managing prediabetes. METHODS: The Behavioral Nudges for Diabetes Prevention (BEGIN) trial is a pragmatic, cluster randomized trial testing the effectiveness of text messaging about diabetes prevention and a prediabetes decision aid. These interventions are being studied in 8 primary care clinics using a 2 × 2 factorial design, in which pairs of clinics are randomized in a 1:1:1:1 ratio to receive usual care, text messaging alone, prediabetes decision aid alone, or both interventions. A total of 656 patients are recruited to participate, receive the study interventions, and contribute data at baseline and 12 months. The primary outcome is 12-month weight change, and the secondary outcome is adoption of evidence-based treatment to prevent diabetes. Change in hemoglobin A1c is an exploratory outcome that will be assessed among participants with available values. CONCLUSION: Findings from the BEGIN trial will provide evidence about the effectiveness of two novel, low-touch interventions focused on diabetes prevention in primary care, where patients are diagnosed with prediabetes and there is little prior research. TRIAL REGISTRY: NCT04869917.

Transanal full-thickness excision for rectal neoplasm: is it advisable to leave the defect open?

PURPOSE: After a full-thickness total wall excision of a rectal tumor, suturing the defect is generally recommended. Recently, due to various contradictory studies, there is a trend to leave the defects open. Therefore, this study aimed to determine whether leaving the defect open is an adequate management strategy compared with suturing it closed based on postoperative outcomes and recurrences. METHODS: A retrospective review of our prospectively maintained database was conducted. Adult patients who underwent transanal surgery for rectal neoplasm in our institution from 1997 to 2019 were analyzed. Patients were divided into two groups: sutured (group A) or unsutured (group B) rectal defect. The primary outcomes were morbidity (early and late) and recurrence. RESULTS: In total, 404 (239 men) patients were analyzed, 143 (35.4%) from group A and 261 (64.6%) from group B. No differences were observed in tumor size, distance from the anal verge or operation time. The overall incidence of complications was significantly higher in patients from group B, which nearly double the rate of group A. With a mean follow-up of 58 (range, 12-96) months, seven patients presented with a rectal stricture, all of them from group B. CONCLUSIONS: We acknowledge the occasional impossibility of closing the defect in patients who undergo local excision; however, when it is possible, the present data suggest that there may be advantages to suturing the defect closed.

Streamlining clinical research: an ESMO awareness call to improve sponsoring and monitoring of clinical trials.

BACKGROUND: During recent years, the burden of bureaucracy in clinical research has increased dramatically, adversely impacting the activity of investigators and clinical research teams. Although compliance with the Declaration of Helsinki, the guidelines for Good Clinical Practice (GCP), and other applicable regulations remains unquestionable, their overinterpretation and substitution by the internal operating procedures of sponsors and Contract Research Organizations (CROs) have increased the administrative burden. A survey conducted by the European Society for Medical Oncology (ESMO) Clinical Research Observatory (ECRO) among 940 investigators confirmed that they considered that the administrative burden in clinical research is excessive; that administrative procedures could be reduced without affecting the safety and the rights of the patients and the quality of the data; and that bureaucracy represents an obstacle for clinical research. METHODS: A panel of physicians with extensive experience in clinical research, composed by members of the ECRO and the ESMO Scientific Medical and Public Policy divisions, analyzed clinical trial procedures related to administrative workflow, pharmacovigilance, and medical care. RESULTS: The panel identified situations that generate debate between investigators and sponsors/CROs and selected real clinical scenarios that exemplify such situations. The panel discussed and proposed specific recommendations for those situations, based on GCP. CONCLUSIONS: This initiative aspires to streamline clinical research procedures and to become a platform for discussion among all clinical trial stakeholders, with the aim of promoting the sustainability of clinical research and the care of cancer patients.

Ultrasound Doppler enthesitis shows sensitivity to change after biological therapy in spondyloarthritis and psoriatic arthritis patients.

OBJECTIVE: To explore the sensitivity to change in power Doppler (PD) enthesitis in active spondyloarthritis (SpA) and psoriatic arthritis (PsA) patients. METHOD: This was a longitudinal study in patients with SpA and PsA with active disease [patients starting or switching to biological disease-modifying anti-rheumatic drugs (bDMARDs)]. The MAdrid Sonographic Enthesitis Index (MASEI) was performed at baseline and at 3 and 6 month visits. The MASEI and Outcome Measures in Rheumatology (OMERACT) PD enthesitis definitions were checked. Reliability analysis among three readers was performed with ultrasound (US)-recorded videos. RESULTS: US examinations of 25 patients were included; 16 (64%) had SpA and nine (36%) PsA. The median (interquartile range, IQR) age was 49 (41-61) years, and 13 patients (52%) were female. The median (IQR) 28-joint Disease Activity Score of 3.6 (2.3-4.2), Bath Ankylosing Spondylitis Disease Activity Index of 6.7 (6.1-7.4), and C-reactive protein value of 8.2 (1.6-20) reflected moderate to high disease activity at baseline. Both MASEI and OMERACT PD enthesitis improved significantly at 3 and 6 month follow-up (p < 0.05) and showed sensitivity to change (standard error of measurement = 0.47 and 0.61, respectively). Improvement in clinical activity outcomes was significantly associated with decreases in MASEI and OMERACT PD enthesitis counts (p < 0.05). The MASEI and OMERACT PD definitions had excellent reliability (kappa = 0.918 and 0.865, respectively). CONCLUSION: PD enthesitis significantly improved at 3 and 6 month follow-up in patients undergoing bDMARD therapy. Both MASEI and OMERACT PD US enthesitis reflect response to treatment.

Variation in intraabdominal pressure in patients with acute heart failure according to left ventricular ejection fraction. Results of an intraabdominal pressure study.

BACKGROUND: The increase in intraabdominal pressure (IAP) has been correlated with increased creatinine levels in patients with heart failure with severely reduced left ventricular ejection fraction (HFrEF). However, IAP has not been examined in more stable patients or those with heart failure with preserved ejection fraction (HFpEF). PATIENTS AND METHOD: We conducted an observational, prospective descriptive study that measured the IAP of patients hospitalised for decompensated heart failure (HF). The sample was stratified according to left ventricular ejection fraction (LVEF), with a cut-off of 50%. The objective was to analyse the IAP, the baseline characteristics and degree of congestion using clinical ultrasonography and impedance audiometry. RESULTS: The study included 56 patients, 22 with HFrEF and 34 with HFpEF. The patients with HFrEF presented a higher prevalence of ischaemic heart disease (11% vs. 6%; p = 0.010) and chronic obstructive pulmonary disease/asthma (6% vs. 2%; p = 0.025). The IAP was higher in the patients with HFrEF (17.2 vs. 13.3 mmHg; p = 0.004), with no differences in renal function at admission according to the LVEF (CKD-EPI creatinine) (HFrEF 55.0 mL/min/1.73 m2 [32.6-83.6] vs. HFpEF 55.0 mL/min/1.73 m2 [44.0-74.9]; p = 0.485). The patients with HFrEF presented a more congestive profile determined through ultrasonography (inferior vena cava collapse [26% vs. 50%; p = 0.001]), impedance audiometry (total body water at admission, 46 L vs. 41 L; p = 0.052; and at 72 h, 50.2 L vs. 39.1 L; p = 0.038) and CA125 concentration (68 U/mL vs. 39 U/mL; p = 0.037). CONCLUSIONS: During the decompensation episodes, the patients with HFrEF had a greater increase in IAP and a higher degree of systemic congestion.

Prognostic value of multimodal assessment of congestion in acute heart failure.

BACKGROUND: A physical examination has limited performance in estimating systemic venous congestion and predicting mortality in patients with heart failure. We have evaluated the usefulness of the N-terminal prohormone of brain natriuretic peptide (NT-proBNP), cancer antigen 125 (CA125), lung ultrasound findings, relative plasma volume (rPV) estimation, and the urea/creatinine ratio as surrogate parameters of venous congestion and predictors of mortality. METHODS: This work is a retrospective study of 203 patients admitted for acute heart failure in a tertiary hospital's internal medicine department with follow-up in a specialized outpatient clinic between 2013 and 2018. Clinical data were collected from hospital records. Treatment was decided upon according to the clinical judgment of each patient's attending physician. The main outcome measure was all-cause mortality at one year of follow-up. RESULTS: Patients' mean age was 78.8 years and 47% were male. A total of 130 (65%) patients had chronic heart failure, 51 (26.2%) patients were in New York Heart Association class III-IV, and 116 (60%) patients had preserved left ventricular ejection fraction. During follow-up, 42 (22%) patients died. Values of NT-proBNP≥3804pg/mL (HR 2.78 [1.27-6.08]; p=.010) and rPV≥-4.54% (HR 2.74 [1.18-6.38]; p=.019) were independent predictors of all-cause mortality after one year of follow-up. CONCLUSIONS: NT-proBNP and rPV are independent predictors of one-year mortality among patients hospitalized for decompensated heart failure.

Atezolizumab in locally advanced or metastatic urothelial cancer: a pooled analysis from the Spanish patients of the IMvigor 210 cohort 2 and 211 studies.

BACKGROUND: The studies IMvigor 210 cohort 2 and IMvigor211 evaluated the efficacy of atezolizumab in patients with locally advanced or metastatic urothelial cancer (mUC) upon progression to platinum-based chemotherapy worldwide. Yet, the real impact of this drug in specific geographical regions is unknown. MATERIALS AND METHODS: We combined individual-level data from the 131 patients recruited in Spain from IMvigor210 cohort 2 and IMvigor211 in a pooled analysis. Efficacy and safety outcomes were assessed in the overall study population and according to PD-L1 expression on tumour-infiltrating immune cells. RESULTS: Full data were available for 127 patients; 74 (58%) received atezolizumab and 53 (42%) chemotherapy. Atezolizumab patients had a numerically superior median overall survival although not reaching statistical significance (9.2 months vs 7.7 months). No statistically significant differences between arms were observed in overall response rates (20.3% vs 37.0%) or progression-free survival (2.1 months vs 5.3 months). Nonetheless, median duration of response was superior for the immunotherapy arm (non-reached vs 6.4 months; p = 0.005). Additionally, among the responders, the 12-month survival rates seemed to favour atezolizumab (66.7% vs 19.9%). When efficacy was analyzed based on PD-L1 expression status, no significant differences were found. Treatment-related adverse events of any grade occurred more frequently in the chemotherapy arm [46/57 (81%) vs 44/74 (59%)]. CONCLUSION: Patients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab.

A multidisciplinary consensus on the morphological and functional responses to immunotherapy treatment.

The implementation of immunotherapy has radically changed the treatment of oncological patients. Currently, immunotherapy is indicated in the treatment of patients with head and neck tumors, melanoma, lung cancer, bladder tumors, colon cancer, cervical cancer, breast cancer, Merkel cell carcinoma, liver cancer, leukemia and lymphomas. However, its efficacy is restricted to a limited number of cases. The challenge is, therefore, to identify which subset of patients would benefit from immunotherapy. To this end, the establishment of immunotherapy response criteria and predictive and prognostic biomarkers is of paramount interest. In this report, a group of experts of the Spanish Society of Medical Oncology (SEOM), the Spanish Society of Medical Radiology (SERAM), and Spanish Society of Nuclear Medicine and Molecular Imaging (SEMNIM) provide an up-to-date review and a consensus guide on these issues.

Effect of haptic geometry in C-loop intraocular lenses on optical quality.

The biomechanical stability of intraocular lenses (IOLs) must achieve high-quality optical performance and clinical outcomes after cataract surgery. For this reason, the quality and performance features of the IOLs should be previously analysed following the Standard ISO 11979-2 and ISO 11979-3. The ISO 11979-3 tries to reproduce the behaviour of the IOL in the capsular bag by compressing the lens between two clamps. With this test, it has been demonstrated that the haptic design is a crucial factor to obtain biomechanical stability. Hence, the main goal of this study was to design an aberration-free aspheric IOL and to study the influence of haptic geometry on the optical quality. For that purpose, 5 hydrophobic IOLs with different haptic design were manufactured and their biomechanical stability was compared experimentally and numerically. The IOLs were classified as stiff and flexible designs depending on their haptic geometry. The biomechanical response was measured by means of the compression force, the axial displacement, the angle of contact or contact area, the decentration, the tilt and the strain energy. The results suggest that in vitro and in silico compression tests present similar responses for the IOLs analysed. Furthermore, the flexible IOL designs presented better biomechanical stability than stiff designs. These results were correlated with the optical performance, where the optical quality decreases with worst biomechanical stability. This numerical methodology provides an indisputable advance regarding IOL designs, leading to reduce costs by exploring a feasible space of solutions during the product design process and prior to manufacturing.