Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study.

PURPOSE: The aim of this study was to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis. METHODS: This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle. RESULTS: The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P < 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0-1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P < 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild. CONCLUSIONS: After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy.

Fluoroscopic placement of nasojejunal feeding tubes in COVID-19 patients in the prone position.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has caused an increase in patients requiring enteral feeding access while undergoing proning for severe acute respiratory distress syndrome (ARDS). We investigated the safety and feasibility of fluoroscopy-guided nasojejunal (NJ) feeding tube placement in the prone position. METHODS: This is a retrospective cohort study of all patients who underwent fluoroscopic placement of NJ feeding tubes at a single institution between March 2020 and December 2020. Primary end points were success rate and number of attempts. Chi-squared and Fischer exact tests were used to compare prone and supine groups. RESULTS: A total of 210 patients were included in the study: 53 patients received NJ feeding tubes while prone and 157 while supine. All but one patient in the prone group had ARDS secondary to COVID-19, whereas 47 (30.3%) had COVID-19 in the supine group. The rate of successful placement was 94.3% in the prone group and 100% in the supine group. Mean number of attempts was 1.1 (SD, ±0.4) in the prone and 1.0 (SD, ±0.1) in the supine group (P = .14). Prone patients had a longer median fluoroscopy time (69 s, interquartile range [IQR] = 92; vs 48 s, IQR = 43; P < .001) and received a higher radiation dose during the procedure (47 mGy, IQR = 50; vs 25 mGy, IQR = 33; P = .004). No procedural complications were reported. CONCLUSION: Fluoroscopy-guided NJ feeding tube placement in prone patients is feasible and safe. Patient positioning should not delay obtaining postpyloric feeding access.

Detection of progressive retinal nerve fiber layer thickness loss with optical coherence tomography using 4 criteria for functional progression.

PURPOSE: To compare the rates of retinal nerve fiber layer (RNFL) thickness loss using optical coherence tomography (OCT) in progressing versus nonprogressing eyes using 4 methods to define functional progression. METHODS: Normal and glaucomatous eyes with ≥3 years of follow up were prospectively enrolled. Standard automated perimetry (Swedish Interactive Threshold Algorithm Standard 24-2) and OCT (Stratus OCT, Carl Zeiss Meditec, Dublin, CA) imaging were performed every 6 months in glaucomatous eyes. OCT imaging was performed annually in normal eyes. Functional progression was determined using early manifest glaucoma trial criterion, visual field index (VFI), Progressor software, and the 3-omitting method. RESULTS: Seventy-six eyes (46 glaucoma and 30 normal) of 38 patients were enrolled with a mean follow-up of 43.9 ± 5.02 months (range: 36 to 48 mo). Eleven eyes progressed using Progressor criterion, 5 eyes using VFI, 2 eyes using the 3-omitting method, and 2 eyes using Early Manifest Glaucoma Trial criterion. The annual rate of average RNFL loss (µm/y) was significantly greater (P<0.05) in progressing versus nonprogressing eyes using Progressor (-1.0 ± 1.3 vs. 0.02 ± 1.6), VFI (-2.1 ± 1.1 vs. -0.002 ± 1.4), and the 3-omitting method (-2.2 ± 0.2 vs. -0.1 ± 1.5). Mean rate (µm/y) of average and superior RNFL thickness change was similar (P>0.05) in nonprogressing glaucomatous eyes compared with normal eyes. Using linear mixed-effect models, mean (P<0.001) and peak (P=0.01) intraocular pressure were significantly associated with rate of average RNFL atrophy in glaucomatous eyes. CONCLUSIONS: Despite differences in criteria used to judge functional progression, eyes with standard automated perimetry progression have significantly greater rates of RNFL loss measured using OCT compared with nonprogressing eyes.

The incidence of PICC line-associated thrombosis with and without the use of prophylactic anticoagulants.

BACKGROUND: Indications for peripherally inserted central catheters (PICC) for long-term venous access have grown during the last several years. There are various complications associated with PICC lines, a common one being venous thrombosis. This study's purpose was to determine the incidence of venous thrombosis associated with PICCs with and without prophylactic anticoagulants. METHODS: In this observational, prospective, cohort study, patients with PICC lines were evaluated using Doppler ultrasound for the presence of PICC-associated venous thrombosis at 5-7 days and again at 12-14 days after line placement. When present, clinical signs and symptoms of thrombosis were documented. Fifty-six patients were evaluated for the type of anticoagulation used, if any, and other clinical parameters such as smoking, ambulation, and previous surgery. The incidence of thrombus was then calculated for the entire population as well as for specific patient subgroups. RESULTS: Patient age was 55.7 +/- 2.6 (mean +/- SEM) years, and BMI was 28.2 +/- 1.2 (n = 56). There were 38 (67.9%) nonambulatory subjects, 15 (26.8%) smokers, 4 (7.1%) coagulopathic subjects, 2 (3.6%) patients receiving estrogen-containing medications, 25 (44.6%) who had undergone surgery within the past 6 months, and 5 (8.9%) cancer patients. There were 21/56 patients (37.5%) with thrombus. Patients who received anticoagulation had a 22.9% (8/35) incidence of thrombosis, which was significantly less (P < .05) than for those who received no anticoagulant (13/21, 61.9%). CONCLUSION: The use of anticoagulants for prophylaxis in patients with a PICC line was associated with a decreased rate of associated venous thrombosis.

Hyperemesis gravidarum and fetal outcome.

BACKGROUND: Hyperemesis gravidarum (HG) is reported in 0.5-2% of all pregnancies. The purpose of this research was to evaluate the relationship of maternal HG, neonatal birth weight, and birth outcomes. METHODS: This is a prospective cohort study of 45 patients diagnosed, by Fairweather's criteria, with HG compared with 306 non-HG control pregnant patients with singleton pregnancies. Sociodemographic and clinical data were obtained from the pregnant patients. Neonatal data were also collected, including indicators of neonatal wellness. RESULTS: Significantly higher incidences of being nonwhite (33% vs 16%; p < .05) and of attaining post-high school education (60% vs 38%) were noted in the HG group, relative to controls. Mothers in the control group experienced greater gestational weight gain, 14.9 +/- 0.3 kg (mean +/- SEM) relative to mothers in the HG group (10.6 +/- 1.3 kg). Infants from HG pregnancies manifested significantly lower birth weight (3.23 +/- 0.09 kg vs 3.52 +/- 0.03 kg), younger gestational age (38.4 +/- 0.3 weeks vs 39.7 +/- 0.1 weeks), and a greater length of hospital stay (2.9 +/- 0.5 days vs 1.8 +/- 0.1 day), relative to infants from the control group. After undergoing multivariate analysis, HG was a significant predictor of decreased gestational age and increased hospital length of stay. CONCLUSIONS: Infants born of women who had HG are more likely to experience decreased gestational age and increased length of hospital stay. Efficacy of early and aggressive treatment of HG, including nutrition support, in minimizing these outcomes needs to be studied.

A randomized trial of endoscopic and fluoroscopic placement of postpyloric feeding tubes in critically ill patients.

BACKGROUND: Early postpyloric feeding is considered the accepted method of nutrition support in critically ill patients. Endoscopic and fluoroscopic techniques are associated with the highest percentage of successful placement. The purpose of this study was to compare endoscopic vs fluoroscopic placement of postpyloric feeding tubes in critically ill patients. METHODS: This is a randomized prospective clinical trial. Forty-three patients were randomized to receive feeding tubes by endoscopic or fluoroscopic technique. All procedures were performed at the bedside in the critical care unit. A soft small-bore nonweighted feeding tube was used in all cases. Successful placement was confirmed by either an abdominal x-ray for endoscopic technique or a fluoroscopic radiograph for fluoroscopic technique. RESULTS: Postpyloric feeding tubes were successfully placed in 41 of 43 patients (95%). The success rate using endoscopic technique was 96% (25 of 26), whereas the rate using fluoroscopy was 94% (16 of 17). The average time of successful placement was 15.2 +/- 2.9 (mean +/- SEM) minutes for endoscopic placement and 16.2 +/- 3.2 minutes for fluoroscopic placement, which was not statistically significant (p > .05). CONCLUSIONS: Endoscopic and fluoroscopic placement of postpyloric feeding tubes can safely and accurately be performed at the bedside in critically ill patients. Our results showed no significant difference in the success rate or time of placement between endoscopic vs fluoroscopic placement of postpyloric feeding tubes.