Enteric Type Bartholin Gland Adenocarcinoma: An Unusual Variant of a Rare Neoplasm.

Vulval cancer is rare. With Bartholin gland carcinomas representing <5% of all vulval carcinomas they present both diagnostic and management challenges. There are a small number of cases in the literature describing Bartholin gland carcinomas with unusual histology which necessitates the need to explore the possibility of metastases from elsewhere. We present a case of a 55-yr-old woman presenting with a vulval lesion within the Bartholin gland. Morphology demonstrated enteric type adenocarcinoma and the immunohistochemistry profile was positive for CK7, CK20, CDX2, CEA, and CA19-9. There was no evidence of an alternative primary cancer and the tumor was excised with negative regional sentinel node assessment. Genotyping showed no detectable mutations in KRAS, BRAF or NRAS suggesting a possible future role for anti-EGFR therapy.

Implementing technology to support the deteriorating patient in acute care: evaluating staff views.

BACKGROUND: Early warning scores (EWS) have been widely used to aid in the detection of deterioration. The use of technology, alongside EWS, may improve patient safety and lead to improvements in the accuracy of documentation. AIM: The aim of this service evaluation was to understand nurses' and healthcare support worker views around the implementation of handheld electronic devices for documenting care related to the deteriorating patient. METHODS: Before the implementation of an electronic handheld device, in-depth semi-structured interviews with nursing staff and healthcare support workers were undertaken to explore the context for improvement. The Consolidated Framework for Implementation Research was used to analyse, organise and present data, to ensure systematic inquiry across the range of potential facilitators and challenges perceived by staff. In all, 11 interviews were undertaken across three speciality areas (four wards). FINDINGS: Challenges to the use of new technology included staff apprehension around training and education needs and the uncertainty of technological reliability in the clinical setting. Potential facilitators to support the implementation of this technology were: the potential for improved communication across the individual ward and hospital setting and the potential for more streamlined processes for escalation of concerns. CONCLUSION: Three main recommendations for practice emerged. First, nurses should be involved in the development of the systems. Appropriate time is required to embed the technology in practice. Finally, thought must be given not just to the absolute number of devices required and their reliability, but also how new technology interacts in each individual context.

Do Patients with Cellulitis Need to be Hospitalized? A Systematic Review and Meta-analysis of Mortality Rates of Inpatients with Cellulitis.

BACKGROUND: Cellulitis is a common cause of hospitalization. In the USA, the International Classification of Diseases (ICD) code "other cellulitis and abscess" accounts for 1.4% of all admissions and $5.5 billion in annual costs. The Infectious Disease Society of America recommends hospitalization for patients with cellulitis under certain circumstances but there is little actual clinical evidence to guide the decision to admit. The purpose of this study is to determine the mortality rate of patients hospitalized with cellulitis and to ascertain if the rate is comparable to the rate for low risk patients with community acquired pneumonia that are currently recommended for outpatient management. METHODS: A systematic literature search was conducted for studies of consecutive patients hospitalized with cellulitis or erysipelas that reported inpatient mortality. Study quality was assessed using a modified Newcastle-Ottawa Quality Assessment Scale. The mortality rates from the included studies were pooled using a random effects model. Heterogeneity was estimated using the I2 statistic. RESULTS: Eighteen studies met inclusion criteria. The overall worldwide mortality rate was 1.1% (95% confidence interval (CI), 0.7-1.8). For studies from the USA, the rate was 0.5% (95% CI 0.3-0.9). The actual cause of death was generally poorly described, and only one third of deaths appeared to be due to infection. DISCUSSION: The estimated mortality rate for patients currently being hospitalized for cellulitis is comparable to the mortality rate of patients with community-acquired pneumonia that are recommended for outpatient management by the Pneumonia Severity Index and CURB65 prediction models and strongly endorsed by major infectious disease societies. Outpatient management of these patients could result in large cost savings and may be much preferred by patients.

Norovirus and Clostridium difficile outbreaks: squelching the wildfire.

PURPOSE OF REVIEW: Gastrointestinal outbreaks in the healthcare setting cause increased morbidity and mortality in an already vulnerable population. Optimization of infection prevention measures can be a challenge in healthcare settings. This review describes new literature that may change the traditional infection prevention approach to such outbreaks. RECENT FINDINGS: Asymptomatic carriers of both norovirus and Clostridium difficile can pose risk of transmission to others and the environment. Rapid recognition and diagnosis can decrease the extent of an outbreak. No-touch technologies for environmental disinfection are new and effective tools. Infection prevention consultant services and systems redesign can augment efforts to control baseline infection rates and outbreaks. Antimicrobial stewardship continues to be essential to prevent C. difficile infection. SUMMARY: New approaches are needed to stem the tide of norovirus and C. difficile clusters and outbreaks in healthcare settings. Accurate recognition, testing, and implementation of infection prevention measures can be supported with rapid testing modalities, access to updated guidelines and no-touch disinfection systems. The work-environment culture should be carefully assessed and restructured using human engineering models to promote effective infection prevention practices. Antimicrobial stewardship initiatives are needed at the bedside and at national levels.

Locally advanced vulva cancer: A single centre review of anovulvectomy and a systematic review of surgical, chemotherapy and radiotherapy alternatives. Is an international collaborative RCT destined for the "too difficult to do" box?

INTRODUCTION: Treatment of locally advanced vulva cancer (LAVC) remains challenging. Due to the lack of randomised trials many questions regarding the indications for different treatment options and their efficacy remain unanswered. METHODS: In this retrospective study we provide the largest published series of LAVC patients treated with anovulvectomy, reporting oncological outcomes and morbidity. Additionally, a systematic literature review was performed for all treatment options 1946-2015. RESULTS: In our case series, 57/70 (81%) patients were treated in the primary setting with anovulvectomy and 13 patients underwent anovulvectomy for recurrent disease. The median overall survival (OS) was 69months (1-336) with disease specific survival of 159months (1-336). Following anovulvectomy for primary disease, time to progression and OS were significantly higher in node negative disease (10 vs. 96months; 19 vs. 121months, p<0.0001). Post-surgical complications were observed in 36 (51.4%), the majority of which were Grade I/II infections. There was one peri-operative death. Review of the literature showed that chemotherapy, radiotherapy or combination treatments are alternatives to surgery. Evidence relating to all of these consisted mostly of small retrospective series, which varied considerably in terms of patient characteristics and treatment schedules. Significant patient and treatment heterogeneity prevented meta-analysis with significant biases in these studies. It was unclear if survival or morbidity was better in any one group with a lack of data reporting complications, quality of life, and long term follow-up. However, results for chemoradiation are encouraging enough to warrant further investigation. CONCLUSIONS: There remains inadequate evidence to identify an optimal treatment for LAVC. However, there is sufficient evidence to support a trial of anovulvectomy versus chemoradiation. Discussions and consensus would be needed to determine trial criteria including the primary outcome measure. Neoadjuvant chemotherapy or radiotherapy alone may be best reserved for the palliative setting or metastatic disease.

2018 American Society of Consultant Pharmacists Annual Meeting & Exhibition.

Poster abstracts are evaluated based on the following criteria: significance of the problem to healthy aging or medication management; innovativeness of ideas, methods, and/or approach; methodological rigor of methods and approach; presentation of finding; implications identified for future research, practice, and/or policy; and clarity of writing. Submissions are not evaluated through the peer-reviewed process used by The Consultant Pharmacist. Industry support is indicated, where applicable. Presenting author is in italics. The poster abstract presentation is supported by the ASCP Foundation.

Increased Levels of Macrophage Inflammatory Proteins Result in Resistance to R5-Tropic HIV-1 in a Subset of Elite Controllers.

UNLABELLED: Elite controllers (ECs) are a rare group of HIV seropositive individuals who are able to control viral replication without antiretroviral therapy. The mechanisms responsible for this phenotype, however, have not been fully elucidated. In this study, we examined CD4(+) T cell resistance to HIV in a cohort of elite controllers and explored transcriptional signatures associated with cellular resistance. We demonstrate that a subgroup of elite controllers possess CD4(+) T cells that are specifically resistant to R5-tropic HIV while remaining fully susceptible to X4-tropic and vesicular stomatitis virus G (VSV-G)-pseudotyped viruses. Transcriptome analysis revealed 17 genes that were differentially regulated in resistant elite controllers relative to healthy controls. Notably, the genes encoding macrophage inflammatory protein 1α (MIP-1α), CCL3 and CCL3L1, were found to be upregulated. The MIP-1α, MIP-1ß, and RANTES chemokines are natural ligands of CCR5 and are known to interfere with HIV replication. For three elite controllers, we observed increased production of MIP-1α and/or MIP-1ß at the protein level. The supernatant from resistant EC cells contained MIP-1α and MIP-1ß and was sufficient to confer R5-tropic resistance to susceptible CD4(+) T cells. Additionally, this effect was reversed by using inhibitory anti-MIP antibodies. These results suggest that the T cells of these particular elite controllers may be naturally resistant to HIV infection by blocking R5-tropic viral entry. IMPORTANCE: HIV is a pandemic health problem, and the majority of seropositive individuals will eventually progress to AIDS unless antiretroviral therapy (ART) is administered. However, rare patients, termed elite controllers, have a natural ability to control HIV infection in the absence of ART, but the mechanisms by which they achieve this phenotype have not been fully explored. This paper identifies one mechanism that may contribute to this natural resistance: some elite controllers have CD4(+) T cells that produce high levels of MIP chemokines, which block R5-tropic HIV entry. This mechanism could potentially be exploited to achieve a therapeutic effect in other HIV-seropositive individuals.

The Association Between Frailty and Visual Field Loss in US Adults.

PURPOSE: To describe the association between visual field loss and frailty in a nationally representative cohort of US adults. DESIGN: Retrospective cross-sectional study. METHODS: The cohort included adults 40 years or older with complete eye examination data from the 2005-2006 and 2007-2008 National Health and Nutrition Examination Surveys (NHANES). Visual field loss (VFL) was determined by frequency doubling technology and a 2-2-1 algorithm. A 36-item deficit accumulation-based frailty index was used to divide subjects into 4 categories of increasing frailty severity. RESULTS: Of the 4897 participants, 4402 (93.2%) had no VFL, 301 (4.1%) had unilateral VFL, and 194 (2.73%) had bilateral VFL. Within the sample, 2 subjects197 (53.1%) were categorized as non-frail, 1659 (31.3%) as vulnerable, 732 (11.3%) as mildly frail, and 312 (4.3%) as most frail. In multivariable models adjusted for demographics, visual acuity, and history of cataract surgery, subjects with unilateral VFL had higher adjusted odds of being in a more frail category (adjusted odds ratio [aOR], 2.07; 95% CI, 1.42-3.02) than subjects without VFL. Subjects with bilateral VFL also had higher odds of a more frail category compared to subjects without VFL (aOR, 1.74; 95% CI, 1.20-2.52). CONCLUSIONS: In the 2005-2008 NHANES adult population, VFL is associated with higher odds of frailty, independent of central visual acuity loss. Frail individuals may be more susceptible to diseases that can cause VFL, and/or VFL may predispose to frailty. Additional studies are needed to determine the directionality of this relationship and to assess potential interventions.

Dr. Google vs. Dr. ChatGPT: Exploring the Use of Artificial Intelligence in Ophthalmology by Comparing the Accuracy, Safety, and Readability of Responses to Frequently Asked Patient Questions Regarding Cataracts and Cataract Surgery.

PURPOSE: Patients are using online search modalities to learn about their eye health. While Google remains the most popular search engine, the use of large language models (LLMs) like ChatGPT has increased. Cataract surgery is the most common surgical procedure in the US, and there is limited data on the quality of online information that populates after searches related to cataract surgery on search engines such as Google and LLM platforms such as ChatGPT. We identified the most common patient frequently asked questions (FAQs) about cataracts and cataract surgery and evaluated the accuracy, safety, and readability of the answers to these questions provided by both Google and ChatGPT. We demonstrated the utility of ChatGPT in writing notes and creating patient education materials. METHODS: The top 20 FAQs related to cataracts and cataract surgery were recorded from Google. Responses to the questions provided by Google and ChatGPT were evaluated by a panel of ophthalmologists for accuracy and safety. Evaluators were also asked to distinguish between Google and LLM chatbot answers. Five validated readability indices were used to assess the readability of responses. ChatGPT was instructed to generate operative notes, post-operative instructions, and customizable patient education materials according to specific readability criteria. RESULTS: Responses to 20 patient FAQs generated by ChatGPT were significantly longer and written at a higher reading level than responses provided by Google (p < .001), with an average grade level of 14.8 (college level). Expert reviewers were correctly able to distinguish between a human-reviewed and chatbot generated response an average of 31% of the time. Google answers contained incorrect or inappropriate material 27% of the time, compared with 6% of LLM generated answers (p < .001). When expert reviewers were asked to compare the responses directly, chatbot responses were favored (66%). CONCLUSIONS: When comparing the responses to patients' cataract FAQs provided by ChatGPT and Google, practicing ophthalmologists overwhelming preferred ChatGPT responses. LLM chatbot responses were less likely to contain inaccurate information. ChatGPT represents a viable information source for eye health for patients with higher health literacy. ChatGPT may also be used by ophthalmologists to create customizable patient education materials for patients with varying health literacy.

A trial of discontinuation of empiric vancomycin therapy in patients with suspected methicillin-resistant Staphylococcus aureus health care-associated pneumonia.

Healthcare-associated pneumonia (HCAP) guidelines recommend de-escalating initial antibiotic therapy based on results from lower-respiratory-tract cultures. In the absence of adequate lower respiratory cultures, physicians are sometimes reluctant to discontinue empirical vancomycin, which is given for suspected methicillin-resistant Staphylococcus aureus (MRSA) HCAP. We evaluated a strategy of discontinuing vancomycin if both nasal and throat cultures were negative for MRSA when lower-respiratory-tract cultures were not available. An antimicrobial stewardship team identified patients receiving empirical vancomycin for suspected or proven HCAP but for whom adequate lower-respiratory-tract cultures were not available. Nasal and throat swab specimens were obtained and plated on MRSA selective media. If both nasal and throat MRSA cultures were negative, the stewardship team recommended discontinuation of empirical vancomycin. Demographic and clinical aspects, a clinical pulmonary infection score (CPIS) on the day of the stewardship recommendation, and mortality of patients for whom vancomycin was discontinued were obtained by retrospective chart review. A convenience sample of 91 patients with nasal and throat cultures negative for MRSA in the absence of adequate respiratory cultures had empirical vancomycin therapy discontinued. A retrospective review revealed that 88 (97%) patients had a CPIS of ≤6 on the day of the stewardship recommendation. In-hospital mortality (7.7%) was similar to that of a previous study of de-escalation of antibiotics in pneumonia patients without adequate cultures. In the absence of adequate lower-respiratory-tract cultures, it is reasonable to discontinue empirical vancomycin HCAP therapy in patients with negative MRSA nasal and throat cultures and a CPIS of <6.

Analysis of the Readability and Accountability of Online Patient Education Materials Related to Glaucoma Diagnosis and Treatment.

Purpose: To assess the readability and accountability of online patient education materials related to glaucoma diagnosis and treatment. Methods: We conducted a Google search for 10 search terms related to glaucoma diagnosis and 10 search terms related to glaucoma treatment. For each search term, the first 10 patient education websites populated after Google search were assessed for readability and accountability. Readability was assessed using five validated measures: Flesch Reading Ease (FRE), Gunning Fog Index (GFI), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), and New Dale-Chall (NDC). Accountability was assessed using the Journal of the American Medical Association (JAMA) benchmarks. The source of information for each article analyzed was recorded. Results: Of the 200 total websites analyzed, only 11% were written at or below the recommended 6th grade reading level. The average FRE and grade level for 100 glaucoma diagnosis-related articles were 42.02 ± 1.08 and 10.53 ± 1.30, respectively. The average FRE and grade level for 100 glaucoma treatment-related articles were 43.86 ± 1.01 and 11.29 ± 1.54, respectively. Crowdsourced articles were written at the highest average grade level (12.32 ± 0.78), followed by articles written by private practice/independent users (11.22 ± 1.74), national organizations (10.92 ± 1.24), and educational institutions (10.33 ± 1.35). Websites averaged 1.12 ± 1.15 of 4 JAMA accountability metrics. Conclusion: Despite wide variation in the readability and accountability of online patient education materials related to glaucoma diagnosis and treatment, patient education materials are consistently written at levels above the recommended reading level and often lack accountability. Articles from educational institutions and national organizations were often written at lower reading levels but are less frequently encountered after Google search. There is a need for accurate and understandable online information that glaucoma patients can use to inform decisions about their eye health.

Laparoscopy versus laparotomy for the management of early stage endometrial cancer.

BACKGROUND: Traditionally, surgery for endometrial cancer (hysterectomy with removal of both fallopian tubes and ovaries) is performed through laparotomy. It has been suggested that the laparoscopic approach is associated with a reduction in operative morbidity. Over the last 10 to 15 years there has been a steady increase of laparoscopy for endometrial cancer. This review investigates the evidence of benefits and harms of laparoscopic surgery compared with laparotomy for presumed early stage endometrial cancer. OBJECTIVES: To compare the overall survival (OS) and disease-free survival (DFS) for laparoscopic surgery versus laparotomy in women with presumed early stage endometrial cancer. SEARCH METHODS: We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) Issue 3, 2012, MEDLINE, EMBASE and CINAHL up to April 2012. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies. Trial registers we searched included NHMRC Clinical Trials Register, UKCCCR Register of Cancer Trials, Meta-Register and Physician Data Query Protocol, as well as abstracts of scientific meetings. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing laparoscopy and laparotomy for early stage endometrial cancer. DATA COLLECTION AND ANALYSIS: We independently abstracted data and assessed risk of bias. Hazard ratios (HRs) were used for OS and recurrence-free survival (RFS), risk ratios (RR) for severe adverse events and the mean difference (MD) method was used for continuous outcomes in women who received laparoscopy or laparotomy and these were then pooled in random-effects meta-analyses. MAIN RESULTS: Eight RCTs comparing laparoscopy with laparotomy for the surgical management of early stage endometrial cancer were identified.All eight trials met the inclusion criteria, 3644 women were assessed at the end of the trials. Three trials assessing 359 participants with early stage endometrial cancer, found no statistically significant difference in the risk of death and disease or recurrence between women who underwent laparoscopy and those who underwent laparotomy (HR = 1.14, 95% confidence interval (CI): 0.62 to 2.10) and HR = 1.13, 95% CI: 0.90 to 1.42 for OS and RFS respectively). There was no statistically significant difference in the rate of peri-operative death, women requiring a blood transfusion, and bladder, ureteric, bowel and vascular injury. However, a meta-analysis of two trials found that women in the laparoscopy group lost significantly less blood than those in the laparotomy group (MD = -106.82 mL, 95% CI: -141.59 to -72.06). A further meta-analysis of two trials, which assessed 2923 women and included one very large trial of over 2500 participants, found that the rate of severe post-operative adverse events was significantly lower in the laparoscopy group compared with the laparotomy group (RR = 0.58, 95% CI: 0.37 to 0.91). The large trial did not give a breakdown of these severe post-operative adverse events into different adverse event categories. Most trials were at moderate risk of bias. Hospital stay was reported in all of the trials and results show that on average, laparoscopy was associated with a significantly shorter hospital stay. AUTHORS' CONCLUSIONS: This review has found evidence to support the role of laparoscopy for the management of early endometrial cancer.For presumed early stage primary endometrioid adenocarcinoma of the endometrium, laparoscopy is associated with similar overall and disease-free survival. Laparoscopy is associated with reduced operative morbidity and hospital stay. There is no significant difference in severe post-operative morbidity between the two modalities.

Clinical outcomes following dalbavancin administration in patients with barriers to outpatient parenteral antimicrobial therapy.

Between 2016 and 2021, we retrospectively identified 42 patients receiving ≥1 dose of dalbavancin for osteomyelitis, skin and soft-tissue infection, endocarditis or bacteremia, or septic arthritis. Median antibiotic duration prior to dalbavancin administration was 7 days. Within 90 days, 93% achieved clinical cure, 12% were readmitted, 12% developed hepatotoxicity, and 5% died.

Surveillance of adverse drug events associated with tocilizumab in hospitalized veterans with coronavirus disease 2019 (COVID-19) to inform patient safety and pandemic preparedness.

We evaluated adverse drug events (ADEs) by chart review in a random national sample of 428 veterans with coronavirus disease 2019 (COVID-19) who received tocilizumab (n = 173 of 428). ADEs (median time, 5 days) occurred in 51 of 173 (29%) and included hepatoxicity (n = 29) and infection (n = 13). Concomitant medication discontinuation occurred in 22% of ADE patients; mortality was 39%.

Increasing face-mask compliance among healthcare personnel during the coronavirus disease 2019 (COVID-19) pandemic.

OBJECTIVE: Prior studies of universal masking have not measured face-mask compliance. We performed a quality improvement study to monitor and improve face-mask compliance among healthcare personnel (HCP) during the coronavirus disease 2019 (COVID-19) pandemic. DESIGN: Mixed-methods study. SETTING: Tertiary-care center in West Haven, Connecticut. PATIENTS: HCP including physicians, nurses, and ancillary staff. METHODS: Face-mask compliance was measured through direct observations during a 4-week baseline period after universal masking was mandated. Frontline and management HCP completed semistructured interviews from which a multimodal intervention was developed. Direct observations were repeated during a 14-week period following implementation of the multimodal intervention. Differences between units were evaluated with χ2 testing using the Bonferroni correction. Face-mask compliance between baseline and intervention periods was compared using time-series regression. RESULTS: Among 1,561 observations during the baseline period, median weekly face-mask compliance was 82.2% (range, 80.8%-84.4%). Semistructured interviews were performed with 16 HCP. Qualitative analysis informed the development of a multimodal intervention consisting of audit and passive feedback, active discussion, and increased communication from leadership. Among 2,651 observations during the intervention period, median weekly face-mask compliance was 92.6% (range, 84.6%-97.9%). There was no difference in weekly face-mask compliance between COVID-19 and non-COVID-19 units. The multimodal intervention was associated with an increase in face-mask compliance (ß = 0.023; P = .002). CONCLUSIONS: Face-mask compliance remained suboptimal among HCP despite a facility-wide mandate for universal masking. A multimodal intervention consisting of audit and passive feedback, active discussion, and increased communication from leadership was effective in increasing face-mask compliance among HCP.

Phase 1b Randomized Controlled Study of Short Course Topical Recombinant Human Nerve Growth Factor (rhNGF) for Neuroenhancement in Glaucoma: Safety, Tolerability, and Efficacy Measure Outcomes.

PURPOSE: No approved therapies directly target retinal ganglion cells (RGCs) for neuroprotection or neuroenhancement in glaucoma. Recombinant human nerve growth factor (rhNGF) has been shown to promote RGC survival and function in animal models of optic neuropathy. Here we evaluate the safety, tolerability, and efficacy of short-term, high-dose rhNGF eye drops versus placebo in a cohort of glaucoma patients. DESIGN: This was a prospective, phase 1b, single-center, randomized, double-masked, vehicle-controlled, parallel-group study. METHODS: This study was designed to assess safety and tolerability as well as short-term neuroenhancement of structure and function (clinicaltrials.gov NCT02855450). A total of 60 open-angle glaucoma patients were randomized 40:20 to receive either 180 µg/mL rhNGF or vehicle control eye drops in both eyes, 3 times daily for 8 weeks, with a 24-week post-treatment follow-up. One eye was officially selected as the study eye, although both eyes were studied and dosed. Primary endpoints were safety, as assessed by adverse events, and tolerability, as assessed by patient-reported outcomes. Secondary outcome measures included best corrected visual acuity (BCVA), Humphrey visual field, electroretinograpy (ERG), and optical coherence tomography (OCT) of retinal nerve fiber layer (RNFL) thickness at baseline, after 8 weeks of treatment, and at 4 and 24 weeks after treatment (12 and 32 weeks total). RESULTS: Of the 60 randomized patients, 23 were female (38%) and the average age was 66.1 years. Through week 32, there were no treatment-related serious adverse events, including no unexpectedly severe progression of optic neuropathy, no adverse events affecting ocular function or pressure, and no drug-related systemic toxicity. Topical high-dose rhNGF was tolerated well, with a low level of symptom burden mainly eliciting periocular ache (in 52% of treated group and 5% of placebo group) and only 3 patients (7.5%) discontinuing treatment because of discomfort, of whom 1 patient (2.5%) prematurely withdrew from the study. There were no statistically significant differences in global indices of Humphrey visual field and no meaningful differences in total, quadrant, or clock-hour mean RNFL thickness between the groups, although both of these function and structure measures showed nonsignificant trends toward significance in favor of rhNGF. Real-world participant data was used to generate an estimate of cohort size needed to power subsequent studies. CONCLUSIONS: Use of rhNGF is safe and tolerable in a topical 180-µg/mL formulation. Although no statistically significant short-term neuroenhancement was detected in this trial, given the strong effects of NGF in preclinical models and the trends detected in this study, analysis for efficacy in a neuroprotection trial is warranted. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.

Comparison of Using One Trabecular Microbypass Stent versus Two during Cataract Surgery at Two Sites: One-Year Follow-Up.

PURPOSE: To compare IOP and ocular hypotensive medication reduction of using one trabecular microbypass stent versus two in patients with open-angle glaucoma. Setting. Palo Alto Veterans Affairs (VA) Hospital and the Byers Eye Institute at Stanford University, Palo Alto, California, USA. DESIGN: Retrospective case series. METHODS: A chart review included patients who underwent trabecular microbypass implantation with cataract surgery in 2015-2017, with at least one-year follow-up. Subjects were divided into two groups by location (always one stent at Stanford versus two stents at the VA). Primary outcome measures included IOP and medication reduction at baseline and 12-month follow-up. RESULTS: 132 subjects (166 eyes) were included. The preoperative IOP was 16.3 ± 3.4 mmHg on 2.6 ± 1.1 medications in the one-stent group (N = 85) and 17.5 ± 3.1 mmHg on 2.7 ± 0.6 medications in the two-stent group (N = 81). There was no significant difference between the two groups (p = 0.06). At the 12-month visit, there was a 13.37% ± 2.93 reduction in IOP in the 1-stent group (p ≤ 0.001) and 13.49% ± 2.69 in the 2-stent group (p ≤ 0.001); both were not significantly different from each other (p = 0.074). At 12 months, there was also a 14.5% reduction in medication use for the 1-stent group and 15.3% reduction in the 2-stent group, both statistically significant from baseline, (p = 0.022 and p = 0.037, respectively). CONCLUSIONS: Implantation with either one or two stents during cataract surgery in patients with glaucoma demonstrated similar IOP and med reduction in both groups between the two sites.

Comparison of 1-Year Effectiveness of Trabecular Microbypass Stent implantation (iStent) in Conjunction With Phacoemulsification Among Mild, Moderate, and Severe Primary Open-angle Glaucoma Patients.

PRECIS: The study compared 1-year effectiveness of single trabecular microbypass stent (iStent) implantation with phacoemulsification among glaucoma severities in primary open-angle glaucoma. The study found that mild glaucoma had greater success rate and lower number of medications compared with moderate and severe glaucoma. PURPOSE: To evaluate the effectiveness of iStent implantation in combination with cataract surgery in moderate to severe glaucoma compared with mild glaucoma. METHODS: Medical charts of primary open-angle glaucoma subjects undergoing 1 iStent implantation were retrospectively reviewed. Glaucoma was classified on the basis of mean deviation (MD) of the preoperative standard automated perimetry into mild (MD>-6 dB), moderate (MD -6 to -12 dB), and severe (MD<-12 dB). Mixed effect regression models were performed to determine the effect of iStent at 1 year. The outcomes included as follows: (1) intraocular pressure (IOP) and the number of medications, (2) eyes with IOP ≤ severity-based target (18 mm Hg for mild, 15 mm Hg for moderate, 12 mm Hg for severe) (2A) without medication, and (2B) with medication reduction. RESULTS: In total, 104 eyes from 89 subjects were analyzed. Cataract combined with iStent surgery significantly lowered the number of medications in all groups and significantly decreased IOP in moderate and severe glaucoma (P<0.05). There was significantly higher number of medications in moderate (ß: 0.58, P=0.002) and severe (ß: 1.20, P<0.001) compared with mild glaucoma. Eyes with moderate glaucoma had significantly lower rate of success (criterion 2A) compared with mild glaucoma [odds ratio (OR): 0.008, P=0.047]. Eyes with moderate and severe glaucoma had significantly lower rates of success (criterion 2B) (moderate vs. mild OR: 0.002, P=0.028; severe vs. mild OR: 0.026, P=0.026). CONCLUSIONS: Combined phacoemulsification with iStent seems to have a better IOP-lowering and medication-lowering effect in mild glaucoma cases versus those with moderate and severe glaucoma. This difference was found in real-world data over one-year follow-up period. Long-term studies with defined IOP goals and medication removal protocols are warranted.