Efficacy and Safety of a Preservative-Free Latanoprost Cationic Emulsion in Patients with Open-Angle Glaucoma and Concurrent Ocular Surface Disease: A Randomized Phase 2 Study.

Purpose: To compare intraocular pressure (IOP), ocular surface disease (OSD) parameters, and safety in patients with open-angle glaucoma (OAG)/ocular hypertension (OH) and concurrent OSD treated with preservative-free latanoprost 0.005% cationic emulsion (PF-latanoprost-E) or travoprost-Z 0.004% ophthalmical solution containing a soft preservative system. Methods: Patients with OAG/OH and OSD were randomized to treatment with PF-latanoprost-E or travoprost-Z nightly for 3 months. Outcomes included mean diurnal IOP reduction; OSD endpoints, including symptom improvement, tear break-up time (TBUT), and corneal fluorescein staining (CFS) score; and safety after 1 and 3 months. Results: A total of 105 patients were randomized, 51 to PF-latanoprost-E and 54 to travoprost-Z. IOP reductions (LS mean differences) at 3 months were numerically greater in the PF-latanoprost-E than in the travoprost-Z group at 8AM (7.2 versus 6.0 mmHg), 10AM (6.7 versus 5.9 mmHg), and 4PM (6.0 versus 5.4 mmHg). LS mean changes in IOP from baseline in both groups at 1 and 3 months, however, were comparable. Mean ± SD CFS scores on the Ora scale at month 3 showed significantly greater reductions in the PF-latanoprost-E than in the travoprost-Z group (-1.07 ± 1.863 versus -0.16 ± 2.553 P = 0.0461). The mean TBUT at month 3 showed similar improvements in both groups (1.1 versus 1.0 s, P > 0.05). OSD symptoms improved but did not differ significantly in the two groups. Overall safety was comparable in both groups. Conclusion: PF-latanoprost-E effectively and safely lowered IOP and improved OSD parameters in patients with OAG/OH. These findings provide evidence for the beneficial effects of this new formulation of latanoprost in glaucoma patients with OSD.

Challenging Dogma by Skipping the Emergency Department Thoracotomy: A Propensity Score Matched Analysis of the Trauma Quality Improvement Database.

INTRODUCTION: Survival following emergency department thoracotomy (EDT) for patients in extremis is poor. Whether intervention in the operating room instead of EDT in select patients could lead to improved outcomes is unknown. We hypothesized that patients who underwent intervention in the operating room would have improved outcomes compared to those who underwent EDT. METHODS: We conducted a retrospective review of the Trauma Quality Improvement Program database from 2017 to 2021. All adult patients who underwent EDT, operating room thoracotomy (ORT), or sternotomy as the first form of surgical intervention within 1 h of arrival were included. Of patients without prehospital cardiac arrest, propensity score matching was utilized to create three comparable groups. The primary outcome was survival. Secondary outcomes included time to procedure. RESULTS: There were 1865 EDT patients, 835 ORT patients, and 456 sternotomy patients who met the inclusion criteria. There were 349 EDT, 344 ORT, and 408 sternotomy patients in the matched analysis. On Cox multivariate regression, there was an increased risk of mortality with EDT versus sternotomy (HR 4.64, P < 0.0001), EDT versus ORT (HR 1.65, P < 0.0001), and ORT versus sternotomy (HR 2.81, P < 0.0001). Time to procedure was shorter with EDT versus sternotomy (22 min versus 34 min, P < 0.0001) and versus ORT (22 min versus 37 min, P < 0.0001). CONCLUSIONS: There was an association between sternotomy and ORT versus EDT and improved mortality. In select patients, operative approaches rather than the traditional EDT could be considered.

Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials.

Design: Prospective, double-masked, controlled, cross-over superiority studies. Materials & methods: Eligible volunteers in two pooled Phase III trials received microdosed mydriatics. MIST-1 study subjects received fixed-combination TR-PH, phenylephrine 2.5% (PH) or tropicamide 1% (TR). MIST-2 study subjects received TR-PH or placebo. Mean change from baseline in pupil diameter was measured by digital pupillometry at 35 min postadministration. Results: Pooled efficacy analysis included 131 subjects. Compared with TR-PH, treatment group difference in 35-min change in mean pupil dilation from baseline was 0.58 mm (p < 0.0001) with TR, 3.87 mm (p < 0.0001) with PH and 4.65 mm (p < 0.0001) with placebo. Adverse events reported were infrequent, transient and mostly mild. Conclusion: TR-PH demonstrated superior pupil dilation compared with each component and placebo. TR-PH was safe & well-tolerated.

Performance and Safety of a New Ab Interno Gelatin Stent in Refractory Glaucoma at 12 Months.

PURPOSE: To evaluate the intraocular pressure (IOP)-lowering performance and safety of an ab interno gelatin stent (XEN 45 Gel Stent, Allergan plc, Irvine, California, USA), a minimally invasive glaucoma surgery device, in refractory glaucoma. DESIGN: Single-arm, open-label, multicenter clinical study. METHODS: Following mitomycin C pretreatment, the stent was placed ab interno in patients who failed prior filtering/cilioablative procedure or had uncontrolled IOP on maximum-tolerated medical therapy, with medicated IOP ≥20 and ≤35 mm Hg and visual field mean deviation ≤-3 dB. Primary performance outcomes: patients (%) achieving ≥20% IOP reduction from baseline on the same or fewer medications and mean IOP change from baseline at month 12. Procedure-related complications and ocular adverse events (AEs) were assessed. RESULTS: Sixty-five patients were implanted (intent-to-treat/safety population). At 12 months, 75.4% (46/61; observed data) reported ≥20% IOP lowering from baseline on the same or fewer medications. Mean IOP change from baseline was -9.1 mm Hg (95% confidence interval [CI]: -10.7, -7.5) (n = 52; observed data) at 12 months, excluding patients with missing data (n = 4) and those requiring a glaucoma-related secondary surgical intervention (n = 9). Mean medication count decreased from 3.5 (baseline) to 1.7 (12 months). No intraoperative complications or unexpected postoperative AEs were reported. Most AEs were mild/moderate; common AEs included needling (without sight-threatening complications), nonpersistent loss of best-corrected visual acuity, and transient hypotony (requiring no surgical intervention). CONCLUSIONS: The gelatin stent reduced IOP and medication use without raising unexpected safety concerns, offering a minimally invasive surgical option for refractory glaucoma patients.

Revisiting endotracheal self-extubation in the surgical and trauma intensive care unit: Are they all fine?

OBJECTIVES: Endotracheal self-extubation (ESE) is a serious health care concern. We designed this study to test our hypothesis that not all patients with ESE are successful in spontaneous breathing and reintubation has negative impact on outcomes. METHODS: Data on all 39 patients of ESE in our surgical and trauma intensive care unit (ICU) in 2012 were prospectively collected and retrospectively analyzed. RESULTS: There were 42 episodes of ESE in 39 of 939 intubated patients (frequency, 4.0%), with 54% of events requiring reintubation. Pre-ESE positive end-expiratory pressure was higher and Pao2/fraction of inspired oxygen ratio was lower, and the post-ESE respiration rate was higher in the reintubated group. On univariate analysis, weaning and spontaneous breathing trial before ESE were favorable predictors for nonreintubation. Multivariate regression analysis demonstrated that agitation before ESE was an independent predictor of reintubation. The need for reintubation was associated with increased risk of pulmonary infectious complications, ventilator days, the need for tracheostomy, and ICU and hospital LOS. The financial costs for ventilator days and ICU rooms were significantly higher in patients with reintubation. CONCLUSION: Not all patients were fine after ESE. We have not decreased the frequency of ESE or improved outcomes if the patients were reintubated. The need for reintubation was not only associated with a high pulmonary complication rate but also prolonged duration on mechanical ventilation and hospital/ICU stay and increased the hospital costs.

Do we really rely on fast for decision-making in the management of blunt abdominal trauma?

INTRODUCTION: The Focused Assessment with Sonography in Trauma examination (FAST) is currently taught and recommended in the ATLS(®), often as an addendum to the primary survey for patients with blunt abdominal trauma. Although it is non-invasive and rapidly performed at bedside, the utility of FAST in blunt abdominal trauma has been questioned. We designed this study to examine our hypothesis that FAST is not an efficacious screening tool for identifying intra-abdominal injuries. METHODS: We performed a retrospective chart review of all patients with confirmatory diagnosis of blunt abdominal injuries with CT and/or laparotomy for a period of 1.5 years (from 7/2009 to 11/2010). FAST was performed by ED residents and considered positive when free intra-abdominal fluid was visualized. Abdominal CT, or exploratory laparotomy findings were used as confirmation of intra-abdominal injury. RESULTS: A total of 1671 blunt trauma patients were admitted to and evaluated in the Emergency Department during a 1½ year period and 146 patients were confirmed intra-abdominal injuries by CT and/or laparotomy. Intraoperative findings include injuries to the liver, spleen, kidneys, and bowels. In 114 hemodynamically stable patients, FAST was positive in 25 patients, with a sensitivity of 22%. In 32 hemodynamically unstable patients, FAST was positive in 9 patients, with a sensitivity of 28%. A free peritoneal fluid and splenic injury are associated with a positive FAST on univariate analysis, and are the independent predictors for a positive FAST on multiple logistic regression. CONCLUSION: FAST has a very low sensitivity in detecting blunt intraabdominal injury. In hemodynamically stable patients, a negative FAST without a CT may result in missed intra-abdominal injuries. In hemodynamically unstable blunt trauma patients, with clear physical findings on examination, the decision for exploratory laparotomy should not be distracted by a negative FAST.

Splenic conservation: variation between pediatric and adult trauma centers.

OBJECTIVES: Nonoperative management of hemodynamically stable children and adolescents with splenic injury regardless of grade has become standard; however, numerous studies have shown a wide variation in management. We compared the treatment and outcomes of adolescent splenic injuries in our region, which includes a pediatric level I trauma center (PTC) and an adult level I trauma center (ATC). METHODS: A retrospective review of the trauma registry was performed on patients 14 to 17 y old with blunt splenic injury admitted to either the local PTC or ATC from January 1999 through December 2010. Demographics, interventions, and hospital course were recorded and compared using Fisher exact, Student t-test, and multivariate analysis. RESULTS: Eighty-six adolescent patients presenting to the PTC and 65 patients presenting to the ATC met the criteria over the 12-y period. Although the ATC received more significantly injured and slightly older patients, logistic multivariate analysis demonstrated that the location of presentation was the only independent factor associated with splenectomy (P = 0.0015). A higher injury severity score was associated with a longer length of stay (LOS), but the nonoperative approach was not associated with a longer LOS (P = 0.96). CONCLUSIONS: Our study demonstrates that the location of presentation was independently associated with splenectomy while controlling for a higher injury severity score at the ATC. With the higher percentage of nonoperative management, treatment at the PTC was not associated with an increased LOS (total or intensive care unit).

U.S. Air Force Mobile Ophthalmic Surgery Team.

OBJECTIVE: The objective of this study was to report the evolution of the U.S. Air Force Mobile Ophthalmic Surgical Team (MOST). METHODS: U.S. Air Force ophthalmologists at Wilford Hall Medical Center in San Antonio, Texas, designed a small, portable, rapid-response eye surgical team. Field testing with humanitarian deployments refined the deployment package and provided operational training. RESULTS: MOST successfully deployed to Central and South America, the Caribbean, and Africa 42 times since 1991, with 50,287 patients examined/treated and 4,812 surgeries performed. Realistic readiness training was provided for 80% of U.S. Air Force ophthalmologists and Army, Navy, and Reserve colleagues. Subsequent modifications to the MOST improved its capability while reducing the size and weight of the team, equipment, and supplies by 50%. CONCLUSIONS: Using MOST humanitarian missions as a refining model, U.S. Air Force deployable ophthalmic assets are modular, lightweight, and multifunctional, which allows commanders to custom-build an appropriate response to each unique contingency, disaster, or humanitarian need with mission-ready ophthalmologists.

Development of a longitudinal study of complications and functional outcomes after traumatic brain injury.

PRIMARY OBJECTIVE: To create a longitudinal database of patients with moderate and severe traumatic brain injury. RESEARCH DESIGN: A prospective study design was used to collect data pertaining to demographics, acute and post-acute management, complications, resource utilization and functional outcomes. METHODS AND PROCEDURES: Data were collected on 233 patients with a Glasgow Coma Score of 12 or less, admitted to a Level 1 Trauma Centre within 24 hours of injury and continued through post-hospitalization follow-up. MAIN OUTCOMES AND RESULTS: The mean age was 37.7 years, 70% were males, 54% were motor vehicle related accidents, and 21% died. Of the 185 survivors, 23% were discharged directly home from acute hospital care and 74% required inpatient rehabilitation. At hospital discharge, 76% had Rancho Los Amigos Scores of VII or higher; 81% had no or only mild verbal communication deficits and 79% were able to ambulate. CONCLUSIONS: The study indicates that while it is difficult to predict functional outcomes for individual survivors of TBI in the early stages of acute care, they are often better than suspected at the time of injury.

Comparison of the frequency doubling technology screening algorithm and the Humphrey 24-2 SITA-FAST in a large eye screening.

PURPOSE: To compare the Frequency Doubling Technology (FDT) C20-1 screening algorithm and the Humphrey Field Analyser II (HFA) 24-2 SITA-FAST in a large eye screening. METHODS: In a non-randomized, prospective, free eye screening, the FDT Screening Protocol (C20-1 Screening Algorithm) was administered to 574 attendees (422 men and 152 women, average age 64, range 17-89 years) of the 1998 Veterans of Foreign Wars (VFW) Convention in San Antonio, Texas. Individuals who failed the FDT (two or more misses out of 17 locations) immediately underwent white-on-white threshold visual field perimetry (HFA 24-2, SITA-FAST). Humphrey visual field analysis included STATPAC and masked evaluations by three glaucoma specialists. RESULTS: Approximately one-tenth of the VFW conference attendees voluntarily presented themselves for screening. Among these 574 volunteers, 69 (12%) failed the FDT and underwent HFA analysis. Eighty-one per cent (56/69) of these FDT failures had abnormal HFA Glaucoma Hemifield Tests. Eighty-eight per cent (61/69) were judged to have nerve fibre type visual field loss on HFA by at least two of three masked examiners. A positive correlation existed between the number of FDT locations missed and the HFA mean deviation (r = 0.5, P = 0.0001). A similar association was observed when FDT and HFA results were analysed by quadrant (r = 0.5, P < 0.0001). CONCLUSION: There was a low false positive rate and a good positive predictive value comparing the FDT screening algorithm to the HFA 24-2 SITA-FAST in this study. This supports the potential use of FDT as an economical screening device.