Impact on visual acuity and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY).

PURPOSE: The MERCURY study aimed to evaluate the effects on visual acuity and psychological symptoms, and safety, of ranibizumab and subsequent treatment in patients with diabetic macular oedema (DME) and impaired visual acuity (VA). We report data from the prespecified 12-month interim analysis. METHODS: This was a 24-month, phase 4, open-label, single-arm, prospective, observational study conducted at 20 specialised retinal centres in Japan. Participants were 209 patients with DME and impaired VA, not previously treated with either intravitreal or systemic anti-vascular endothelial growth factor (anti-VEGF) agents, who initiated ranibizumab 0.5 mg per investigator discretion. Following ranibizumab administration, patients were treated per routine clinical practice. Other treatments were allowed. The main outcome measure was the mean change in best-corrected VA (BCVA) in logarithmic minimum angle of resolution (logMAR) from baseline to month 12. An exploratory objective was to assess patients' psychological status using the Hospital Anxiety and Depression Scale (HADS). RESULTS: The mean ± standard deviation BCVA at baseline was 0.43 ± 0.39 logMAR. The mean number of injections of ranibizumab and anti-VEGF agents from baseline to month 11 was 3.2 ± 2.0 and 3.6 ± 2.4, respectively. The BCVA change from baseline to 12 months was - 0.08 ± 0.34 logMAR (p = 0.011), showing a significant improvement; the HADS-anxiety score also decreased significantly (p = 0.001) and the depression score decreased numerically (p = 0.080). CONCLUSION: MERCURY study data confirm the effectiveness of real-world treatment initiated with ranibizumab in Japanese patients with DME. In addition, treatment was able to positively influence anxiety via VA improvement.

Real-world data on ranibizumab for myopic choroidal neovascularization due to pathologic myopia: results from a post-marketing surveillance in Japan.

OBJECTIVES: The aim of this study was to obtain real-world clinical data on the safety and efficacy of ranibizumab treatment for myopic choroidal neovascularization (CNV) due to pathologic myopia. METHODS: This was a prospective, observational, post-marketing surveillance study in ranibizumab-naive Japanese patients with myopic CNV. Patients who initiated ranibizumab treatment were registered and prospectively observed over 12 months. Safety endpoints were the incidence of ocular and non-ocular adverse drug reactions (ADRs) and serious adverse events (SAEs). The efficacy endpoint included the average change in best-corrected visual acuity (BCVA) in logarithm of the minimal angle of resolution (logMAR) units (logMAR BCVA) from baseline to the last observation. RESULTS: Three hundred and eighteen patients were included in the safety analysis population. Of these 79.9% were female and the mean age was 65.5 years. The incidences of SAEs and ADRs were 0.6 and 0.3%, respectively. A total of 268 patients (84.0%) completed the 12-month study period. The mean (±SD) and median number of ranibizumab injections were 2.0 ± 1.5 and 1.0 during the 12-month study period, respectively. The number of ranibizumab injections received was one in 52.2% of patients and less than or equal to three in 89.2%. The mean change in logMAR BCVA from baseline to month 12 was -0.193, and the mean logMAR BCVA improved from 0.517 to 0.319 between baseline and month 12. CONCLUSIONS: This study showed that ranibizumab is generally well tolerated, and that a minimum number of injections were necessary to produce a therapeutic effect in Japanese myopic CNV patients in a real-world setting.

Gymnastic Formation-related Injury to Children in Physical Education.

OBJECTIVE: Current data indicate that the rate of trauma in children during gymnastic formation is increasing, especially while creating a structure with a certain height, such as the human pyramid. The goal of the present study was to clarify the clinical characteristics of these injuries. METHODS: In this single-institution review, all children treated for a gymnastic formation-related injury at Nippon Medical School Hospital from 2013 through 2015 were identified through the institution's registry. The injury mechanism was classified, and injury severity, interventions, and outcome were examined. RESULTS: Eight children were treated for a gymnastic formation-related injury. They were 7 boys and 1 girl aged 10 to 15 years (mean age, 13.1±1.8 years). Neurotrauma ranging from concussion to spinal cord injury without radiographic abnormality occurred in 6 patients (75%). No intracranial hemorrhagic lesions were detected. The Glasgow Coma Scale score on arrival was 15 in all 8 patients, and neurological deficits were present in 1 patient. No patient required surgical intervention. All patients made a full recovery after discharge from the hospital. No patients died. The average follow-up period was 2.1±0.9 weeks. CONCLUSIONS: Neurotrauma is a frequent result of gymnastic formation accidents in children. Healthcare workers and teachers should recognize this type of injury, and public education that targets parents should be introduced.

Is it possible to predict the development of an incisional surgical site infection and its severity after biliary tract surgery for benign disease?

BACKGROUND/PURPOSE: Wound infection; that is, incisional surgical site infection (ISSI), is a common complication after biliary tract surgery. The aim of the present study was to identify the various risk factors for wound infection and to establish a formula to predict the development and severity of wound infections. METHODS: We analyzed the clinical data on 207 consecutive patients who underwent biliary surgery for benign diseases at our hospital. We identified the factors with the greatest influence on wound infection after biliary tract surgery, based on a statistical procedure. An original scoring system (ISSI predictive score) was proposed based on these risk factors. RESULTS: The incidence of postoperative wound infection was 9.7% (20/207). The patient's performance status; bile culture; perioperative fasting period (days); and intraoperative bile spillage were the most influential risk factors for wound infection. The incidences of wound infection in patients with ISSI predictive scores of >2.7 points and those with scores of 0-2.7 points were 75.0% (12/16) and 4.2% (8/191), respectively. Our score also correlated significantly with the severity of wound infection (r = 0.488, P < 0.001) and the length of the postoperative hospital stay (R = 0.508, P < 0.001). CONCLUSION: Our original scoring system makes it possible to predict not only the development of a wound infection and its severity after biliary tract surgery, but also the length of the postoperative hospital stay.