Narrative review after post-hoc trial analysis of factors that predict corneal endothelial cell loss after phacoemulsification: Tips for improving cataract surgery research.

PURPOSE: Identifying pre/perioperative factors that predict corneal endothelial-cell loss (ECL) after phacoemulsification may reveal ways to reduce ECL. Our literature analysis showed that 37 studies have investigated one or several such factors but all have significant limitations. Therefore, the data of a large randomized controlled trial (PERCEPOLIS) were subjected to post-hoc multivariate analysis determining the ability of nine pre/perioperative variables to predict ECL. METHODS: PERCEPOLIS was conducted in 2015-2016 to compare two phacoemulsification techniques (subluxation and divide-and-conquer) in terms of 3-month ECL. Non-inferiority between the techniques was found. In the present study, post-hoc univariate and multivariate analyses were conducted to determine associations between ECL and age, sex, cataract density, preoperative endothelial-cell density, phacoemulsification technique, effective phaco time (EPT), and 2-hour central-corneal thickness. The data are presented in the context of a narrative review of the literature. RESULTS: Three-month data were available for 275 patients (94% of the randomized cohort; mean age, 74 years; 58% women). Mean LOCSIII cataract grade was 3.2. Mean EPT was 6 seconds. Mean ECL was 13%. Only an older age (beta = 0.2%, p = 0.049) and higher EPT (beta = 1.2%, p = 0.0002) predicted 3-month ECL. Cataract density was significant on univariate (p = 0.04) but not multivariate analysis. The other variables did not associate with ECL. CONCLUSIONS: Older age may amplify ECL due to increased endothelial cell fragility. EPT may promote ECL via cataract density-dependent and -independent mechanisms that should be considered in future phacoemulsification research aiming to reduce ECL. Our literature analysis showed that the average ECL for relatively unselected consecutively-sampled cohorts is 12%.

Manufacture and use of transparent facial orthotic masks for treating facial burn scars: A systematic review.

BACKGROUND: Custom-made transparent facial orthoses (TFOs) (face masks) are used to improve facial burn scars. We conducted a systematic literature review on TFO manufacture and use. METHODS: Pubmed and Cochrane databases were searched without restrictions for relevant articles. TFO manufacture details and use according to international recommendations (20-32 mmHg pressure, TFO worn 20-23 h/day for ≥2 months) were extracted. RESULTS: Of 279 retrieved articles, 11 published over the last 41 years (four in the last 5 years) discussed TFO manufacture/use. There were five technical notes, five case reports, and a patient-cohort study (total patients in the studies=21). TFO-manufacture methods could be categorized as classical, digital, or mixed classical-digital. Relative clinical efficacies and cost advantages were unclear. The plastics used, harness materials, harness-point number, and silicone-interface use differed from study to study. Target pressure, actual pressure, expected daily wearing time, and treatment duration ranged widely and often did not meet current guidelines. Actual wearing time and treatment duration were never measured. CONCLUSIONS: Although TFOs play an important global role in burn care, there is a grave paucity of research. Further research is needed to promote the standardization of TFO-related practices and thereby improve the outcomes of facial-burn patients.

Five-year clinical outcomes of 107 consecutive DMEK surgeries.

PURPOSE: The long-term clinical outcomes, postoperative complications, and graft survival of Descemet-membrane endothelial keratoplasty (DMEK) remain poorly understood. We retrospectively assessed these variables in all consecutive eyes that underwent DMEK for any indication in 2014-2018. The findings were compared to the long-term DMEK studies of five other groups (3-10-year follow-up). METHODS: Patients underwent ophthalmological tests preoperatively, at 1, 3, 6, and 12 postoperative months, and then annually. Five-year graft survival was determined by Kaplan-Meier estimator. Change in best-corrected visual acuity (BCVA), endothelial-cell density (ECD), and central-corneal thickness (CCT) at each timepoint was determined. RESULTS: 107 eyes (80 patients; 72 years old; 67% female) underwent first-time DMEK for uncomplicated Fuchs endothelial corneal dystrophy (94% of eyes), pseudophakic bullous keratopathy (3%), and regraft after previous keratoplasty (3%). The most common complication was graft detachment requiring rebubbling (18%). Thirteen grafts (12%) failed at ≤15 months. Cumulative 5-year graft-survival probability was 88% (95% confidence intervals = 79-94%). BCVA improved from 0.6 logMAR preoperatively to 0.05 logMAR at 1 year (p<0.0001) and then remained stable. Donor ECD dropped by 47% at 6 postoperative months and then continued to decrease by 4.0%/year. Five-year endothelial-cell loss was 65% (from 2550 to 900 cells/mm2). CCT dropped from 618 to 551 µm at 5 years (p<0.0001). These findings are generally consistent with previous long-term DMEK studies. CONCLUSIONS: DMEK has low complication and high graft-survival rates and excellent clinical outcomes that persist up to 5 years post-surgery. DMEK seems to be a safe and effective treatment in the long term.

Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial.

INTRODUCTION: Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy. METHODS AND ANALYSIS: This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1-4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events. ETHICS AND DISSEMINATION: The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications. TRIAL REGISTRATION NUMBER: NCT04985695.

Postoperative, but not preoperative, central corneal thickness correlates with the postoperative visual outcomes of Descemet membrane endothelial keratoplasty.

Descemet membrane endothelial keratoplasty (DMEK) restores visual acuity in patients with progressive corneal endothelial diseases such as Fuchs endothelial corneal dystrophy (FECD). However, patients often prefer to delay the surgery as long as possible, even though outcomes are poorer in advanced FECD. A recent study proposed that preoperative central corneal thickness (CCT) of ≥625 µm associated with worse best spectacle-corrected visual acuity (BSCVA) after DMEK for FECD. Since this threshold could signal to both surgeons and patients when to perform DMEK, we further explored the relationship between CCT and BSCVA with a retrospective cohort study. The cohort consisted of all patients with FECD who underwent DMEK in a tertiary-care hospital in 2015-2020 and were followed for 12 months. Extremely decompensated corneas were not included. Relationships between preoperative CCT and BSCVA on days 8 and 15 and months 1, 3, 6, and 12 were examined with Pearson correlation analyses. Eyes with preoperative CCT <625 or ≥625 µm were also compared in terms of postoperative BSCVA. Relationships between postoperative CCT and final BSCVA were also explored. The cohort consisted of 124 first-operated eyes. Preoperative CCT did not correlate with postoperative BSCVA at any timepoint. Eye subgroups did not differ in postoperative BSCVA. However, postoperative CCT at 1-12 months correlated significantly with 12-month BSCVA (r = 0.29-0.49, p = 0.020-0.001). Thus, postoperative, but not preoperative, CCT correlated with postoperative BSCVA. This phenomenon may reflect factors that distort preoperative CCT measurements but disappear after surgery. This observation and our analysis of the literature suggest that while there is a relationship between CCT and post-DMEK visual acuity, preoperative CCT measurements may not always adequately reflect that relationship and may therefore not be a reliable predictor of DMEK visual outcomes.

Evolution of hematocrit in burn patients as a marker of early fluid management during acute phase.

OBJECTIVE: To evaluate the value of hematocrit for monitoring fluid resuscitation of burn patients in the acute phase of their care. METHOD: We conducted a single-center retrospective study focused on patients admitted with a burn surface of more than 20 % of the total body surface area (TBSA) from 2014 to 2021. We investigated the relationship between the change in hematocrit and the volume administered for patient resuscitation. The change in hematocrit is the difference between an admission hematocrit and a second one taken between the eighth and twenty-fourth hour. RESULTS: We included 230 patients with an average burn size of 39.1 ± 20.3 % TBSA, in 94.4 % by a thermal mechanism. The management seems to be in accordance with the current recommendations, with a volume administered during the first 24 h of 4.3 ± 2.5 ml/kg/ % BSA, allowing to obtain an hourly diuresis of 0.9 ± 0.7 ml/kg/h. We did not find any correlation between the pre-hospital volume administration and the hematocrit at admission (p = 0.36). Hematocrit decreased on average to -4.5 ± 8.1 % between admission and a control performed after the 8th hour. This decrease was weakly correlated with the volumes infused between the two samples (r2 =0.13, p < 0.001). A resuscitation above 5.2 ml/kg/ % Burn surface area is an independent factor for excess mortality. CONCLUSION: Hematocrit or its variations in our limited data base appears to not reliably detect over-resuscitation, therefore it is possible that it may not be a relevant marker. These conclusions should be clarified in a multi-institutional prospective or real-world analysis to validate the findings and null hypothesis.

Biosensors for the Rapid Detection of Cardiovascular Biomarkers of Vital Interest: Needs, Analysis and Perspectives.

We have previously surveyed a panel of 508 physicians from around the world about which biomarkers would be relevant if obtained in a very short time frame, corresponding to emergency situations (life-threatening or not). The biomarkers that emerged from this study were markers of cardiovascular disease: troponin, D-dimers, and brain natriuretic peptide (BNP). Cardiovascular disease is a group of disorders affecting the heart and blood vessels. At the intersection of medicine, basic research and engineering, biosensors that address the need for rapid biological analysis could find a place of choice in the hospital or primary care ecosystem. Rapid, reliable, and inexpensive analysis with a multi-marker approach, including machine learning analysis for patient risk analysis, could meet the demand of medical teams. The objective of this opinion review, proposed by a multidisciplinary team of experts (physicians, biologists, market access experts, and engineers), is to present cases where a rapid biological response is indeed valuable, to provide a short overview of current biosensor technologies for cardiac biomarkers designed for a short result time, and to discuss existing market access issues.

Effectiveness of Hypnosis for the Prevention of Anxiety During Coronary Angiography (HYPCOR study): a prospective randomized study.

BACKGROUND: Coronary angiography is the gold standard for the diagnosis of coronary artery disease. This intervention is nevertheless a source of anxiety for the patient both by its discomfort and by the consequences linked to the discovery of potential diseases. OBJECTIVES: The aim of this study was to determine the effectiveness of hypnosis in reducing anxiety in patients undergoing coronary angiography. METHODS: One hundred sixty-nine patients with planned coronary angiography and no history of coronary angiography were randomized to a hypnosis or control group. Patients in the hypnosis group underwent a hypnosis session with self-hypnosis posthypnotic suggestions, while those in the control group had a conversational interview with the hypnotherapist. The primary endpoint was pre-exam anxiety level assessed by the Spielberger State-Trait Anxiety Inventory (STAI-Y A). RESULTS: Performing a hypnosis session did not result in a significant decrease in anxiety before the intervention. Age, high trait anxiety, high state anxiety the day before, and belief that hypnosis works in general were associated with increased anxiety before the procedure. No adverse events were reported after hypnosis. There was no statistically significant difference between the 2 groups for the occurrence of complications of the intervention. CONCLUSION: In this study, performing a hypnosis session before coronary angiography did not reduce the state of anxiety measured just before the intervention. In all cases, the hypnotic experience appears to be positive for the patient, encouraging further research efforts. TRIAL REGISTRATION: The research protocol has been registered on the ClinicalTrials.gov registry (NCT02818101; 29/06/2016) and with the ANSM (IDRCB 2016-A00205-46; 02/02/2016).

Ability of routinely collected clinical factors to predict good visual results after primary Descemet membrane endothelial keratoplasty: a cohort study.

BACKGROUND: A comprehensive analysis of routinely collected pre/perioperative demographic/clinical factors that could predict final visual acuity after primary Descemet membrane endothelial keratoplasty (DMEK) has not been conducted previously. METHODS: A retrospective monocenter cohort study was performed with consecutive patients with Fuchs endothelial corneal dystrophy (FECD) who underwent DMEK or triple-DMEK (DMEK combined with cataract surgery) in 2016-2020 in a French tertiary-care hospital. DMEK-only patients were pseudophakic. Patients were followed for 12 months. Surgery was considered successful when 12-month best-corrected visual acuity (BCVA) was ≤0.1 logMAR (≥0.8). Exploratory multivariate analysis was conducted with the following routinely collected variables to determine their ability to predict 12-month BCVA: patient age and sex; graft donor age; triple DMEK; preoperative values of BCVA, endothelial cell density (ECD), central corneal thickness (CCT), and mean anterior keratometry; and rebubbling. RESULTS: Of 100 eyes (100 patients; mean age, 72 years; 61% female), 81 achieved a 12-month BCVA of ≤0.1 logMAR. Logistic regression analysis showed that older age was a significant prognosticator for 12-month BCVA > 0.1 logMAR (Odds Ratio = 0.914, 95% confidence intervals = 0.846-0.987; p = 0.02). CONCLUSIONS: An older age associated with worse visual acuity outcomes after DMEK. This was confirmed by our analysis of the literature and supports the notion that DMEK should be conducted without delay once symptoms appear. Patient sex, donor age, triple-DMEK, and anterior keratometry also did not predict final BCVA in the literature. Preoperative CCT, ECD, and BCVA, and rebubbling occasionally appear in the literature as BCVA predictors, possibly reflecting an underlying ECD-BCVA axis.

Comparison of triple-DMEK to pseudophakic-DMEK: A cohort study of 95 eyes.

Previous comparative studies show that triple Descemet membrane endothelial keratoplasty (DMEK) (i.e. phacoemulsification followed immediately by DMEK) has either equivalent or better visual outcomes than DMEK in pseudophakic patients. To resolve this discrepancy, a retrospective cohort study was conducted. All consecutive patients with Fuchs Endothelial Corneal Dystrophy who underwent triple or pseudophakic DMEK in 2015-2019 in a tertiary-care hospital (France) and were followed for >12 months were compared in terms of best spectacle-corrected visual acuity (BSCVA), final refractive outcomes, and endothelial-cell loss at 12 months as well as rebubbling rates. The triple-DMEK (40 eyes, 34 patients) and pseudophakic-DMEK (55 eyes, 43 patients) groups were similar in terms of age and other baseline variables. They also did not differ in final BSCVA (both 0.03 logMAR), final endothelial-cell loss (54% vs. 48%), or astigmatism (-1.25 vs. -1 D). At 12 months, triple-DMEK associated with significantly smaller residual hyperopia (0.75 vs. 1 D; p = 0.04) and spherical equivalence (0 vs. 0.5 D; p = 0.02). Triple-DMEK also tended to associate with more frequent rebubbling (40% vs. 24%, p = 0.09). In conclusion, while triple-DMEK and pseudophakic-DMEK achieved similar visual acuity improvement, triple-DMEK was superior in terms of final sphere and spherical refraction but also tended to have higher complication rates.

Evolution of corneal transplantation techniques and their indications in a French corneal transplant unit in 2000-2020.

PURPOSE: This retrospective cohort study assessed the evolution of corneal transplantation and its indications in the last 21 years (2000-2020) in a specialized ophthalmology department in a tertiary referral center in France. METHODS: The surgical techniques and indications, patient age and sex, and postoperative best-corrected visual acuity (BCVA) 6 months after keratoplasty were extracted. RESULTS: In total, 1042 eyes underwent keratoplasty in 2000-2020. Annual numbers of corneal transplantations increased by 2.2-fold. Penetrating keratoplasty (PKP) was the sole technique for the first 11 years. Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) were introduced in 2011 and 2014, respectively. Cases of both quickly increased, accounting for 28% and 41% of cases in 2015-2020, respectively. Eventually, DSAEK and DMEK were respectively used for most pseudophakic bullous keratopathy (PBK) and all Fuchs endothelial cell dystrophy (FECD) cases. PKP cases declined to 27%. Deep anterior lamellar keratoplasty (DALK) was rare (3% of all cases). These changes associated with rises in PBK and particularly FECD cases, and a strong decline in keratoconus, causing FECD, PBK, and keratoconus to move from being the 4th, 1st, and 3rd most common indications to the 1st, 2nd, and 6th, respectively. On average, BCVA improved by 0.1-0.3 logMAR. Patient age dropped steadily over time. Female predominance was observed. CONCLUSIONS: The invention of DSAEK and then DMEK precipitated an enormous change in clinical practice and a large expansion of keratoplasty to new indications. This study confirms and extends previous findings in other countries.

Comparison of SARS-CoV-2 Variants of Concern Alpha (B.1.1.7) vs. Beta (B.1.351) in Critically Ill Patients: A Multicenter Cohort Study.

Objectives: The clinical outcomes of the Beta (B.1.351) variant of concern (VOC) of the SARS-CoV-2 virus remain poorly understood. In early 2021, northeastern France experienced an outbreak of Beta that was not observed elsewhere. This outbreak slightly preceded and then overlapped with a second outbreak of the better understood VOC Alpha (B.1.1.7) in the region. This situation allowed us to contemporaneously compare Alpha and Beta in terms of the characteristics, management, and outcomes of critically ill patients. Methods: A multicenter prospective cohort study was conducted on all consecutive adult patients who had laboratory confirmed SARS CoV-2 infection, underwent variant screening, and were admitted to one of four intensive care units (ICU) for acute respiratory failure between January 9th and May 15th, 2021. Primary outcome was 60-day mortality. Differences between Alpha and Beta in terms of other outcomes, patient variables, management, and vaccination characteristics were also explored by univariate analysis. The factors that associated with 60-day death in Alpha- and Beta-infected patients were examined with logistic regression analysis. Results: In total, 333 patients (median age, 63 years; 68% male) were enrolled. Of these, 174 and 159 had Alpha and Beta, respectively. The two groups did not differ significantly in terms of 60-day mortality (19 vs. 23%), 28-day mortality (17 vs. 20%), need for mechanical ventilation (60 vs. 61%), mechanical ventilation duration (14 vs. 15 days), other management variables, patient demographic variables, comorbidities, or clinical variables on ICU admission. The vast majority of patients were unvaccinated (94%). The remaining 18 patients had received a partial vaccine course and 2 were fully vaccinated. The vaccinated patients were equally likely to have Alpha and Beta. Conclusions: Beta did not differ from Alpha in terms of patient characteristics, management, or outcomes in critically ill patients. Trial Registration: ClinicalTrials.gov, identifier: NCT04906850.

Evaluation of the impact of an enhanced recovery after surgery (ERAS) programme on the quality of recovery in patients undergoing a scheduled hysterectomy: a prospective single-centre before-after study protocol (RAACHYS study).

INTRODUCTION: The enhanced recovery after surgery (ERAS) programmes following hysterectomies have been studied since 2010, and their positive effects on clinical or economic criteria are now well established. However, the benefits on health outcomes, especially rapid recovery after surgery from patients' perspective is lacking in literature, leading to develop scores supporting person-centred and value-based care such as patient-reported outcome measures. The aim of this study is to assess the impact of an ERAS programme on patients' well-being after undergoing hysterectomy. METHODS AND ANALYSIS: This is an observational, prospective single-centre before-after clinical trial. 148 patients are recruited and allocated into two groups, before and after ERAS programme implementation, respectively. The ERAS programme consists in optimising factors dealing with early rehabilitation, such as preoperative patient education, multimodal pain management, early postoperative fluid taken and mobilisation. A self-questionnaire quality of recovery-15 (QoR-15) on the preoperative day 1 (D-1), postoperative day 0 evening (D0) and the postoperative day 1 (D+1) is completed by patients. Patients scheduled to undergo hysterectomy, aged 18 years and above, whose physical status are classified as American Society of Anesthesiologists score 1-3 and who are able to return home after being discharged from hospital and contact their physician or the medical department if necessary are recruited for this study. The total duration of inclusion is 36 months. The primary outcome is the difference in QoR-15 scores measured on D+1 which will be compared between the 'before' and the 'after' group, using multiple linear regression model. ETHICS AND DISSEMINATION: Approval was obtained from the Ethical Committee (Paris, France). Subjects are actually being recruited after giving their oral agreement or non-objection to participate in this clinical trial and following the oral and written information given by the anaesthesiologist practitioner.Trial registration number: ClinicalTrials.gov: NCT04268576 (Pre-result).

Chest CT Characteristics are Strongly Predictive of Mortality in Patients with COVID-19 Pneumonia: A Multicentric Cohort Study.

RATIONALE AND OBJECTIVES: The novel coronavirus (COVID-19) has presented a significant and urgent threat to global health and there has been a need to identify prognostic factors in COVID-19 patients. The aim of this study was to determine whether chest computed tomography (CT) characteristics had any prognostic value in patients with COVID-19. MATERIALS AND METHODS: A retrospective analysis of COVID-19 patients who underwent a chest CT-scan was performed in four medical centers. The prognostic value of chest CT results was assessed using a multivariable survival analysis with the Cox model. The characteristics included in the model were the degree of lung involvement, ground glass opacities, nodular consolidations, linear consolidations, a peripheral topography, a predominantly inferior lung involvement, pleural effusion, and crazy paving. The model was also adjusted on age, sex, and the center in which the patient was hospitalized. The primary endpoint was 30-day in-hospital mortality. A second model used a composite endpoint of admission to an intensive care unit or 30-day in-hospital mortality. RESULTS: A total of 515 patients with available follow-up information were included. Advanced age, a degree of pulmonary involvement ≥50% (Hazard Ratio 2.25 [95% CI: 1.378-3.671], p = 0.001), nodular consolidations and pleural effusions were associated with lower 30-day in-hospital survival rates. An exploratory subgroup analysis showed a 60.6% mortality rate in patients over 75 with ≥50% lung involvement on a CT-scan. CONCLUSION: Chest CT findings such as the percentage of pulmonary involvement ≥50%, pleural effusion and nodular consolidation were strongly associated with 30-day mortality in COVID-19 patients. CT examinations are essential for the assessment of severe COVID-19 patients and their results must be considered when making care management decisions.

Relevant Biomarkers in Medical Practices: An Analysis of the Needs Addressed by an International Survey.

(1) Backround: Technological advances should foster gains in physicians' efficiency. For example, a reduction of the medical decision time can be enabled by faster biological tests. The main objective of this study was to collect responses from an international panel of physicians on their needs for biomarkers and also to convey the improvement in the outcome to be made possible by the potential development of fast diagnostic tests for these biomarkers. (2) Methods: we distributed a questionnaire on the Internet to physicians. (3) Results: 508 physicians participated in this survey. The mean age was 38 years. General practice and emergency medicine were heavily represented, with 95% CIs of 44% (39.78, 48.41) and 32% (27.84, 35.94)), respectively. The two most represented countries were France (95% CI: 74% (70.20, 77.83)) and the USA (95% CI: 11% (8.65, 14.18)). Ninety-eight percentages of the physicians thought that obtaining cited biomarkers more quickly would be beneficial to their practice and to patient's care. The main biomarkers of interest identified by our panel were troponin (95% CI: 51% (46.24, 54.94)), C-reactive protein (95% CI: 42% (38.03, 46.62)), D-dimer (95% CI: 29% (24.80, 32.68)), and brain natriuretic peptide (95% CI: 13% (10.25, 16.13)). (4) Conclusions: Our study highlights the real technological need for fast biomarker results, which could be provided by biosensors. The relevance of some answers such as troponin is questionable.

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

INTRODUCTION: Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care. METHODS AND ANALYSIS: We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics. ETHICS AND DISSEMINATION: This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39.

Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study.

PURPOSE: It remains unclear whether preoperative central graft thickness (CGT) contributes to visual outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK). This retrospective cohort study examined the ability of preoperative and postoperative CGT to predict 12-month best spectacle-corrected visual acuity (BSCVA) after DSAEK for Fuchs endothelial corneal dystrophy/moderate pseudophakic bullous keratopathy/second graft. METHODS: All consecutive patients who underwent DSAEK in 2015 to 2018 were included. The primary end point was 12-month BSCVA. DSAEK-CGT was measured preoperatively and 6 times between postoperative day 8 and month 12. Eyes were divided according to preoperative CGT 130 µm (ultrathin-DSAEK threshold) or 6-month postoperative CGT 100 µm (mean 6-month postoperative DSAEK-CGT). The t test assessed CGT evolution of the 4 groups over time. Multivariate analyses examined whether preoperative CGT or 6-month CGT categories predicted 12-month BSCVA. Multivariate analysis assessed the preoperative/perioperative factors that predicted 6-month CGT. RESULTS: A total of 108 eyes (68 patients) underwent DSAEK. Preoperative CGT was >130 and ≤130 µm in 87 and 21 eyes, respectively. Postoperative CGT was >100 and ≤100 µm in 50 and 58 eyes, respectively. Thin 6-month postoperative grafts thinned significantly more relative to preoperative thickness than thick grafts ( P < 0.001). Preoperative CGT subgroups did not show this difference. Six-month postoperative CGT ( P = 0.01), but not preoperative CGT, predicted 12-month BSCVA. Preoperative CGT strongly predicted 6-month CGT ( P = 0.0003). CONCLUSIONS: Postoperative, but not preoperative, DSAEK-CGT predicted 6-month BSCVA. The correlation between preoperative and postoperative CGT and interstudy variation in preoperative CGT measurement accuracy may explain literature disparities regarding the importance of preoperative CGT in DSAEK outcomes.

Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial.

PURPOSE: Subluxation techniques are superior to divide-and-conquer in procedure duration, pain, and ultrasound quantity, but their safety in endothelial cell loss (ECL) is unclear. This randomized single-blind noninferiority clinical trial aimed to determine whether subluxation supracapsular phacoemulsification techniques are inferior to a reference endocapsular technique (divide-and-conquer) regarding postoperative corneal ECL. METHODS: Patients (aged18 years or older) with greater than +0.2 logarithm of the minimum angle of resolution best spectacle-corrected visual acuity and normal to severe density cataract were randomized to subluxation or divide-and-conquer phacoemulsification in 2015 to 2016. Follow-up with ophthalmic tests was conducted on day 4 and months 1, 3, and 12. The primary study outcome was ECL at all time points. Secondary study end points were operative variables, including effective phaco time and procedure duration. A clinically relevant noninferiority ECL limit was established on the basis of the literature. RESULTS: In total, 292 patients (mean age, 73 yrs; 59% female) were randomized and underwent subluxation (n = 148) or divide-and-conquer (n = 144). Day 4 and month 1, 3, and 12 data were available for 243, 270, 275, and 198 patients, respectively. The unexpectedly high dropout at 12 months meant that the 12-month ECL data could only be assessed qualitatively. Surgery was successful in all patients. Subluxation was noninferior to divide-and-conquer in ECL. Effective phaco times were similar, but subluxation associated with shorter procedure duration. CONCLUSIONS: The subluxation technique was noninferior to divide-and-conquer regarding postoperative ECL, at least in the first 3 months, and associated with reduced intervention time. Subluxation techniques may be suitable alternatives to endocapsular techniques.Clinical Trial Registration-URL: ClinicalTrials.gov. Unique identifier: NCT02535819.