Evaluation of the Amblyopia tracker app.

PURPOSE: The Amblyopia tracker app has been developed to be a tool for parents to monitor changes in vision at home during amblyopia treatment. The aims of this study were to evaluate the feasibility and repeatability of parents testing their children at home and to compare home test results to an assessment in clinic by an orthoptist. METHODS: Children (age < 18 years) with amblyopia (interocular acuity difference of ≥ 0.2logMAR) were recruited. Parents were asked to test their child with the app three times during a two week period followed by an online questionnaire about the usability. Participants also tested within 48 h of their appointment where the measurement was repeated by an orthoptist. RESULTS: Out of 277 potential participants contacted, 37 completed three home measurements, mean age 6.8 years (SD 2.94). Home tests comparisons were made between test two and three to ensure familiarity with the process. Paired t-tests showed no statistically significant difference for either eye or the interocular acuity difference (IAD). However, 29% had a difference in IAD of more than 0.1logMAR on repeated testing, with a maximum of 0.4logMAR difference in the IAD. Questionnaire responses from the parents who participated were predominantly positive with 97% of respondents saying they would use it if were available. Comparison of home and clinical measurements (n = 23, mean age 6.72 SD 2.60) showed no statistically significant differences for either eye or interocular acuity difference (paired t-test, p > 0.3 in all cases). CONCLUSION: Results show no statistically significant differences for the Amblyopia tracker app when used by parents at home on repeated testing, or between the home test by a parent and the test by a clinician. However, variability in the results does indicate that further improvements are required to ensure the results can be used as a reliable clinical tool.

Behavioral Strategies to Minimize Procedural Distress During In-Office Pediatric Tympanostomy Tube Placement Without Sedation or Restraint.

The purpose of this study was to evaluate behavioral strategies to minimize procedural distress associated with in-office tympanostomy tube placement for children without general anesthesia, sedation, or papoose-board restraints. 120 6-month- to 4-year-olds and 102 5- to 12-year-olds were treated at 16 otolaryngology practices. Mean age of children was 4.7 years old (SD = 3.18 years), with more boys (58.1%) than girls (41.9%). The cohort included 14% Hispanic or Latinx, 84.2% White, 12.6% Black, 1.8% Asian and 4.1% 'Other' race and ethnicity classifications. The in-office tube placement procedure included local anesthesia via lidocaine/epinephrine iontophoresis and tube placement using an integrated and automated myringotomy and tube delivery system. Behavioral strategies were used to minimize procedural distress. Anxiolytics, sedation, or papoose board were not used. Pain was measured via the faces pain scale-revised (FPS-R) self-reported by the children ages 5 through 12 years. Independent coders supervised by a psychologist completed the face, legs, activity, cry, consolability (FLACC) behavior observational rating scale to quantify children's distress. Mean FPS-R score for tube placement was 3.30, in the "mild' pain range, and decreased to 1.69 at 5-min post-procedure. Mean tube placement FLACC score was 4.0 (out of a maximum score of 10) for children ages 6 months to 4 years and was 0.4 for children age 5-12 years. Mean FLACC score 3-min post-tube placement was 1.3 for children ages 6 months to 4 years and was 0.2 for children age 5-12 years. FLACC scores were inversely correlated with age, with older children displaying lower distress. The iontophoresis, tube delivery system and behavioral program were associated with generally low behavioral distress. These data suggest that pediatric tympanostomy and tube placement can be achieved in the outpatient setting without anxiolytics, sedatives, or mechanical restraints.

Do Socioeconomic Inequalities Exist Within Ophthalmology and Orthoptics in the UK?: A Scoping Review.

Introduction: It is well documented that socioeconomic disadvantage adversely affects general health and ocular health worldwide. Within orthoptics, while clinicians recognise a relationship between socioeconomic situation and treatment outcome, no previous literature review was found to address this issue. Neither was a UK-specific literature review found to address the same issue for ophthalmology as a whole. Aim: This literature review evaluates evidence for an association between socioeconomic situation and ophthalmic/orthoptic conditions and their treatment outcomes, specifically within the UK. Methods: Keyword searches were conducted on Google Scholar and the University of Liverpool library catalogue. Results for the main analyses were limited to full papers, specific to the UK, written in English. Literature was only included from pre-2000 if more recent evidence was insufficient. Results: There is evidence of socioeconomic disadvantage being associated with the following: reduced visual acuity; reduced attendance at diabetic retinopathy screening appointments; and delayed presentation of glaucoma, cataracts, and diabetic retinopathy. However, evidence linking socioeconomic disadvantage to AMD is mixed. There is limited evidence of the increased prevalence of amblyopia and subsequent barriers to its treatment for socioeconomically underserved children. There is also evidence of a reduction in quality of life for socioeconomically underserved adults with strabismus. Conclusions: Health inequalities within ophthalmology and orthoptics are reported, but with confounding results for some conditions. Further research should explore the reasons behind the inequalities that are found and identify methods of reducing them.

Two-Year Outcomes After Pediatric In-Office Tympanostomy Using Lidocaine/Epinephrine Iontophoresis and an Automated Tube Delivery System.

OBJECTIVE: Evaluate 2-year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in-office. STUDY DESIGN: Prospective, single-arm. SETTING: Eighteen otolaryngology practices. METHODS: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead-In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. RESULTS: Tubes were placed in-office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In-Office cohorts were 15.82 (95% confidence interval [CI]: 15.41-19.05) and 16.79 (95% CI: 16.16-17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow-up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes. CONCLUSION: In-office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet-type tubes and complication rates consistent with traditional tube placement in the OR.

Pharmacokinetics of Single Dose Lidocaine and Epinephrine Following Iontophoresis of the Tympanic Membrane in a Double-Blinded Randomized Trial.

OBJECTIVE: To evaluate local and systemic safety of bilateral iontophoretic administration of lidocaine with epinephrine or lidocaine alone to the tympanic membrane (TM). STUDY DESIGN: A randomized, double-blind, two-arm study was conducted at a single center. Healthy adults were randomized to bilateral iontophoretic treatment with 2% lidocaine, 1:100,000 epinephrine, or 2% lidocaine (control). Otoscopy, cranial nerve examination, tympanometry, and audiometry safety evaluations were conducted before and 3-days post-procedure. Systemic safety was evaluated via analysis of vital signs taken before and up to 120 minutes post-iontophoresis, and blood samples collected before and up to 230 minutes post-iontophoresis. RESULTS: Twenty-five subjects were treated with bilateral iontophoresis of either lidocaine and epinephrine (n = 15 subjects) or lidocaine alone (n = 10). Mean plasma epinephrine concentrations for both groups remained within the normal range for endogenous epinephrine. Mean plasma concentrations of lidocaine were not statistically different between groups, ranging from 0.245 to 2.28 ng/ml after administration of lidocaine with epinephrine (immediate post-iontophoresis to 230 min post-iontophoresis), compared with 1.35 to 2.14 ng/ml after administration of lidocaine alone. The presence of epinephrine slowed the systemic absorption of lidocaine. Lidocaine levels (Cmax 2.24 ng/ml) were approximately 2000-fold lower than the threshold for minor lidocaine toxicity. No device-, procedure- or drug-related adverse events were reported. CONCLUSION: The local and systemic safety of bilateral iontophoretic delivery of 2% lidocaine, 1:100,000 epinephrine to the TM was demonstrated by low plasma levels of drug and absence of both serious and non-serious device-, procedure-, or drug-related adverse events.

Neuroarchitecture of the central complex in the brain of the honeybee: Neuronal cell types.

The central complex (CX) in the insect brain is a higher order integration center that controls a number of behaviors, most prominently goal directed locomotion. The CX comprises the protocerebral bridge (PB), the upper division of the central body (CBU), the lower division of the central body (CBL), and the paired noduli (NO). Although spatial orientation has been extensively studied in honeybees at the behavioral level, most electrophysiological and anatomical analyses have been carried out in other insect species, leaving the morphology and physiology of neurons that constitute the CX in the honeybee mostly enigmatic. The goal of this study was to morphologically identify neuronal cell types of the CX in the honeybee Apis mellifera. By performing iontophoretic dye injections into the CX, we traced 16 subtypes of neuron that connect a subdivision of the CX with other regions in the bee's central brain, and eight subtypes that mainly interconnect different subdivisions of the CX. They establish extensive connections between the CX and the lateral complex, the superior protocerebrum and the posterior protocerebrum. Characterized neuron classes and subtypes are morphologically similar to those described in other insects, suggesting considerable conservation in the neural network relevant for orientation.

Evaluation of a New Method to Track Changes in Vision at Home for Children Undergoing Amblyopia Treatment.

PURPOSE: A new amblyopia tracker app has been designed to provide parents with a method of monitoring a child's vision by presenting a single optotype size that the tester moves to identify the furthest distance the optotypes can be seen. The aim of this study is to evaluate this methodology in adults, comparing the findings to visual acuity (VA) measured with the iSight app and to determine the test retest variability. METHODS: Adults, aged 18-39 years, with no known eye condition and VA ≤ 0.7 logMAR were recruited. Bangerter filters were used to simulate amblyopia, where VA was reduced below 0.0 with an interocular difference of at least 0.2 logMAR. Testing for both apps was performed monocularly, with the test order being randomised. RESULTS: Data from 32 subjects were analysed. For the test retest variability analysis, paired t-tests showed no statistically significant difference between the tests for either eye, either app or the interocular acuity difference (p > 0.3 in all cases). Bland Altman plots showed similar limits of agreement between the two apps. When comparing measurements between the apps there was no statistically significant difference on the first or second test, either eye or the interocular acuity difference (p > 0.5 in all cases). CONCLUSION: The results support the theory that changing distance is a valid method of assessing VA as the measurements agree well with the standard approach of reducing optotype size. Test retest variability is similar between the two apps and there is good agreement between the measurements.

The Accuracy of GP Referrals into Manchester Royal Eye Hospital Orthoptic Department.

BACKGROUND: There is little research that examines the accuracy of paediatric referrals into secondary and tertiary care, particularly those from general practicioners (GPs) to ophthalmology and orthoptic departments. Inaccurate referrals could have a detrimental effect on service delivery and NHS funding as well as patient experience. Available evidence shows GP referral accuracy to range between 39% and 90% across different areas of medicine with accuracy of GP referral to ophthalmology between 56% and 66%. METHODS: A retrospective case note analysis was carried out on 99 case notes to examine the accuracy of paediatric GP referrals (including those via the community optometrist) into the Orthoptic Department at Manchester Royal Eye Hospital (MREH). RESULTS: GP referral accuracy was found to be 63% for strabismus cases, 50% for reduced vision/amblyopia cases, 45% for NAD cases, 100% of nystagmus cases and 92% of "other" cases. GPs were significantly less accurate than community optometrists (p = 0.01). Referrals from GPs alone had an accuracy rate of 65% compared to 87% of GP referral via community optometrist. Accuracy of referral appeared to improve with age, however this was not found to be statistically significant (p = 0.06). CONCLUSION: This study found orthoptic referral accuracy for GPs in Manchester to be similar to other areas of medicine. While acceptable compared to other areas of medicine, improving referral accuracy is essential to improve NHS spending, service delivery, and patient experience. To aid with this the aim is to design and implement a virtual training package that focuses on detection of strabismus to improve referral accuracy.

The Contribution of Galenics to Patients' Sensory Perception of Nasal Sprays After Nasal Surgery: Data from a Prospective Randomised, Controlled, Double-Blind, Crossover, Multicentre Study.

INTRODUCTION: Postoperative care after nasal surgery is commonly achieved with nasal sprays. The current study compared two decongesting, wound-healing nasal sprays in patients after nasal surgery in order to investigate their sensory perception. One of the sprays was a new galenic formulation (nasic® neo, Cassella-med GmbH & Co. KG). METHODS: According to the crossover design, patients who had undergone nasal surgery applied two different nasal sprays during two treatment periods of 4 days each, interrupted by a 3-day washout period. Sensory perception of the nasal sprays was assessed with the nasal spray sensoric scale. Throughout the study, nasal obstruction was evaluated by patients, and physical examinations, measurements of vital parameters and rhinoscopic examinations were carried out by investigators. Adverse events were documented during the entire study, and following treatment, patients judged the overall preference, efficacy and tolerability of both products. RESULTS: Overall, no significant differences in sum scores of the assessments of the nasal spray sensoric scale were observed between treatments. A significant period effect observed during the crossover study limited the overall analysis. Nevertheless, significantly more patients preferred the new galenics nasal spray compared to the comparator spray (57.1% vs. 34.7%; p = 0.031). Further, 10% more patients rated the efficacy of the new galenics as 'good' to 'very good' compared to the comparator. Importantly, a subgroup population of patients with more pronounced signs of inflammation present at screening evaluated the sensory perception of the new galenics as significantly better (p = 0.033) compared to the comparator. Within this subgroup, no period effect was observed. The application of both nasal sprays was shown to be safe and well-tolerated. CONCLUSION: The overall sensory perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and overall the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray. Patients with marked nasal abnormalities may have a greater benefit from the contribution of galenics as significant differences in the sensory evaluation by the nasal spray sensoric scale in favour of the new galenics product were shown for this subgroup. TRIAL REGISTRATION: The current study was registered in the EU Clinical Trials Register with the EudraCT No. 2019-004936-52.

In-Office Tympanostomy Tube Placement Using Iontophoresis and Automated Tube Delivery Systems.

OBJECTIVES: (1) To evaluate safety, tolerability, and technical success of lidocaine iontophoresis and a tympanostomy tube placement system for adults in an office setting and (2) to meet regulatory evidence requirements for new drugs and devices. STUDY DESIGN: Prospective, multicenter, single arm. SETTING: Patients were recruited in 8 community-based practices in the United States between June and September 2017. SUBJECTS AND METHODS: This study evaluated tympanic membrane anesthesia and tube placement in 30 adults. Anesthesia was achieved via iontophoresis of a lidocaine/epinephrine solution. Tube placement was conducted using an integrated myringotomy and tube delivery system. Tolerability of tube placement was measured using a patient-reported visual analog scale from 0 mm (no pain) to 100 mm (worst possible pain). Mean pain score was compared to a performance goal of 45 mm, where statistical superiority represents mild pain or less. Technical success and safety through 3 weeks postprocedure were evaluated. RESULTS: Twenty-nine (29/30, 96.7%) patients had tube(s) successfully placed in all indicated ears. One patient demonstrated inadequate tympanic membrane anesthesia, and no tube placement was attempted. The mean (SD) pain score of 9.4 (15.7) mm was statistically superior to the performance goal. There were no serious adverse events. Seven nonserious events were related to device, procedure, or drug: inadequate anesthesia (1), vertigo (1), and dizziness (1) at the time of procedure and ear discomfort (1), tube occlusion (2), and medial tube migration (1) postprocedure. CONCLUSION: Lidocaine iontophoresis provides acceptable tympanic membrane anesthesia for safe, tolerable, and successful in-office tube placement using an integrated myringotomy and tube delivery system.

In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery.

OBJECTIVES/HYPOTHESIS: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting. STUDY DESIGN: Prospective individual cohort study. METHODS: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain). RESULTS: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures. CONCLUSIONS: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system. LEVEL OF EVIDENCE: 2b Laryngoscope, 130:S1-S9, 2020.

Bagolini filter bars: an analysis of light transmittance and their use in a pediatric population.

Purpose: The purpose of this study is to determine whether the Sbisa bar (Sbisa Ophthalmic Instruments) (referred to in this article as the BF(Sbisa) bar) and Bagolini Filter bar (C.O.I. Vision) (referred to in this article as the BF(new) bar) are repeatable and comparable, for measuring density of suppression or strength of abnormal binocular single vision (BSV), in a pediatric population. Methods: Using a spot photometer, percentage light transmittance of filters on two BF(Sbisa) bars and two BF(new) bars was measured. Thirty-three participants aged 5-12 years with unilateral strabismus were recruited. Density of suppression or strength of abnormal BSV was measured with two of each bar, in addition to a repeated measure with one of each bar. Results: Light transmittance did not reduce consistently with increasing filter number (the number assigned to each filter by the manufacturer). Using data as filter numbers, a BF(Sbisa) bar was not comparable to a BF(new) bar (ᵶ = -3.936, p < 0.001, r = -0.28); different BF(Sbisa) bars were not comparable (ᵶ = -3.103, p = 0.005, r = -0.22) but different BF(new) bars were comparable (ᵶ = -1.165, p = 1.285, r = -0.08). Using light transmittance values, a BF(Sbisa) bar was comparable to a BF(new) bar (ᵶ = -0.385, p = 3.535, r = -0.03); different BF(Sbisa) bars were comparable (ᵶ = -1.476, p = 0.720, r = -0.10) but different BF(new) bars were not comparable (ᵶ = -3.354, p < 0.001, r = -0.24). The BF(Sbisa) and BF(new) bars were not repeatable using filter numbers (ᵶ = -3.648, p < 0.001, r = -0.26 and ᵶ = -3.099, p = 0.005, r = -0.22, respectively) or light transmittance values (ᵶ = -3.743, p < 0.001, r = -0.27 and ᵶ = -2.727, p = 0.025, r = -0.19, respectively). An order effect existed using filter numbers (ᵶ = -4.473, p < 0.001, r = -0.32) and light transmittance values (ᵶ = -4.525, p < 0.001, r = -0.32). Conclusion: There is a need for the production of bars with consistently reducing and comparable light transmittance of filters if measurement of density of suppression or strength of abnormal BSV with filter bars is to continue, because the current bars show inconsistencies, particularly at lower filter numbers. In the meantime, the bars are limited by their lack of comparability or repeatability. Using only BF(new) bars is preferable to using BF(Sbisa) bars or a mixture of the two types of bar because two different BF(new) bars may be comparable using filter number readings, but filter number readings from different BF(Sbisa) bars or from a BF(Sbisa) and BF(new) bar are not comparable. As the BF(Sbisa) and BF(new) bars are currently labeled, a second measure of density of suppression or strength of abnormal BSV is not recommended within 2 min of an initial measurement, because the measurement procedure seems to cause a reduction in suppression or abnormal BSV that does not recover with repeated measurements 2 min apart.

Evolution of the Rho guanine nucleotide exchange factors Kalirin and Trio and their gene expression in Xenopus development.

Guanine nucleotide exchange factors (GEFs) activate Rho GTPases by accelerating their GDP/GTP exchange. Trio and its paralog Kalirin (Kalrn) are unique members of the Rho-GEFs that harbor three catalytic domains: two functional GEF domains and a serine/threonine kinase domain. The N-terminal GEF domain activates Rac1 and RhoG GTPases, while the C-terminal GEF domain acts specifically on RhoA. Trio and Kalrn have an evolutionary conserved function in morphogenetic processes including neuronal development. De novo mutations in TRIO have lately been identified in patients with intellectual disability, suggesting that this protein family plays an important role in development and disease. Phylogenetic and domain analysis revealed that a Kalrn/Trio ancestor originated in Prebilateria and duplicated in Urbilateria to yield Kalrn and Trio. Only few taxa outside the vertebrates retained both of these highly conserved proteins. To obtain first insights into their redundant or distinct functions in a vertebrate model system, we show for the first time a detailed comparative analysis of trio and kalrn expression in Xenopus laevis development. The mRNAs are maternally transcribed and expression increases starting with neurula stages. Trio and kalrn are detected in mesoderm/somites and different neuronal populations in the neural plate/tube and later also in the brain. However, only trio is expressed in migrating neural crest cells, while kalrn expression is detected in the cranial nerves, suggesting distinct functions. Thus, our expression analysis provides a good basis for further functional studies.

Persistence of naturally occurring and genetically modified Choristoneura fumiferana nucleopolyhedroviruses in outdoor aquatic microcosms.

BACKGROUND: To assess the persistence of genetically modified and naturally occurring baculoviruses in an aquatic environment, replicate (three) outdoor, aquatic microcosms were spiked with spruce budworm viruses [Ireland strain of Choristoneura fumiferana multiple nucleopolyhedrovirus (CfMNPV) and the recombinant CfMNPVegt(-)/lacZ(+)] at a rate of 1.86 x 10(10) occlusion bodies (OBs) m(-2) of surface area. The presence of virus in water samples collected at various times after inoculation was determined by PCR amplification of baculoviral DNA extracted from OBs. RESULTS: Although UV radiation rapidly degrades baculoviruses under natural conditions, both viruses persisted above the level of detection (>100 OBs 450 microL(-1) of natural pond water) for at least 1 year post-inoculation, with little difference between the viruses in their patterns of persistence. CONCLUSION: The present microcosm study suggests that occlusion bodies of baculoviruses can persist in the flocculent layer of natural ponds. On disturbance, OBs could re-enter the main water column and thus be available for transport to new locations. Implications for environmental risk assessment are discussed.

Quantification and persistence of recombinant DNA of Roundup Ready corn and soybean in rotation.

The presence of the recombinant cp4 epsps gene from Roundup Ready (RR) corn and RR soybean was quantified using real-time PCR in soil samples from a field experiment growing RR and conventional corn and soybean in rotation. RR corn and RR soybean cp4 epsps persisted in soil for up to 1 year after seeding. The concentration of recombinant DNA in soil peaked in July and August in RR corn and RR soybean plots, respectively. A small fraction of soil samples from plots seeded with conventional crops contained recombinant DNA, suggesting transgene dispersal by means of natural process or agricultural practices. This research will aid in the understanding of the persistence of recombinant DNA in agricultural cropping systems.

Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study.

BACKGROUND: Although previous studies of sinus surgery that used balloon catheter dilation technology for the paranasal sinuses (balloon sinus dilation [BSD]) demonstrated safety and efficacy, data that compare BSD with continued medical management (MM) are lacking. OBJECTIVE: To evaluate the outcomes of sinus surgery when using BSD instruments versus MM for patients with chronic rhinosinusitis for whom MM failed. METHODS: Adult patients with chronic rhinosinusitis for whom a minimum of 3 weeks of oral antibiotics, 4 weeks of daily saline solution therapy, and 4 weeks of daily nasal corticosteroids failed were included. Qualifying participants were allowed to self-select sinus surgery with BSD (either an office or operating room setting) or continued MM. The primary end point was the comparison of change in the Chronic Sinusitis Survey score from baseline to 24 weeks. Secondary end points included comparisons of change for the Rhinosinusitis Disability Index (RSDI) and the Sino-Nasal Outcome Test (SNOT-20). RESULTS: A total of 198 patients were enrolled (146 surgery and 52 MM). Of the patients who chose BSD, 72% (105/146) had their procedures completed in an office setting. Overall, BSD instruments were successful in dilating 97.6% of targeted sinuses (561/575). Patients who chose BSD showed a significantly greater improvement in the Chronic Sinusitis Survey score versus MM (42.0 versus 27.0, p < 0.001). Results from the RSDI and SNOT-20 surveys showed similar improvements for surgery versus MM (RSDI, 36.0 versus 18.1, p < 0.001; SNOT-20, 1.7 versus 1.0, p < 0.002). CONCLUSION: Patients who selected sinus surgery in which BSD instruments were used on the peripheral sinuses demonstrated significantly greater improvements in quality of life compared with those who elected ongoing MM. These results were achieved through office-based procedures with the patient under local anesthesia in the majority of patients.

The microbial DNA cycle in soil.

Upon microbial cell death and lysis in soil, the free or naked DNA is exposed to the dynamic environment of the soil. The DNA can be enzymatically degraded by nucleases (DNases), bind to soil components, genetically transform competent bacterial cells and be a nutrient for other microorganisms. In this article we discuss the dual role of DNA as genetic material and as a nutrient source in the soil environment.

Effect of monopolar radiofrequency treatment over soft-tissue fillers in an animal model: part 2.

BACKGROUND AND OBJECTIVE: Monopolar radiofrequency (RF) treatment is used by physicians to heat skin and promote tissue tightening and contouring. Cosmetic fillers are used to soften deep facial lines and wrinkles. Patients who have had dermal fillers implanted may also benefit from or are candidates for monopolar RF skin tightening. This study examined the effect of RF treatment on various dermal filler substances. This is the second part of a two-part study. STUDY DESIGN/MATERIALS AND METHODS: A juvenile farm pig was injected with dermal fillers including cross-linked human collagen (Cosmoplast), polylactic acid (PLA) (Sculptra), liquid injectable silicone (Silikon 1000), calcium hydroxylapatite (CaHA) (Radiesse), and hyaluronic acid (Restylane). Skin injected with dermal fillers was RF-treated using a 1.5-cm2 treatment tip and treatment levels typically used in the clinical setting. Fillers were examined histologically 5 days, 2 weeks, or 1 month after treatment. Histological specimens were scored for inflammatory response, foreign body response, and fibrosis in order to assess the effect of treatment on early filler processes, such as inflammation and encapsulation. RESULTS: Each filler substance produced a characteristic inflammatory response. No immediate thermal effect of RF treatment was observed histologically. RF treatment resulted in statistically significant increases in the inflammatory, foreign body, and fibrotic responses associated with the filler substances. CONCLUSIONS: Monopolar RF treatment levels that are typically used in the clinical setting were employed in this animal study. RF treatment resulted in measurable and statistically significant histological changes associated with the various filler materials. Additional clinical and histological studies are required to determine the optimal timing of monopolar RF treatment and filler placement for maximal potential aesthetic outcome.

Effects of monopolar radiofrequency treatment over soft-tissue fillers in an animal model.

BACKGROUND AND OBJECTIVES: Monopolar radiofrequency (RF) treatment is used by physicians to tighten and contour the skin of their patients. In many cases, patients have received prior treatment with other aesthetic modalities such as soft-tissue augmentation or they may wish to receive these treatment modalities simultaneously. Together, soft-tissue augmentation and monopolar RF treatment have the potential to restore tissue volume and improve facial laxity. To date, no published studies have documented the effects of RF treatment directly over soft-tissue fillers. STUDY DESIGN/MATERIALS AND METHODS: We examined the tissue interactions of monopolar RF heating with five commonly injected fillers in a juvenile pig model. This is the first part of a two-part study. In this study, the interaction of monopolar RF and filler substances was examined over a period of 4 months. The five soft-tissue fillers examined were cross-linked human collagen (Cosmoplast), hyaluronic acid (Restylane), calcium hydroxylapatite (Radiesse), polylactic acid (Sculptra), and liquid injectable silicone (Silikon 1000). RESULTS: There was no apparent increase in the risk of local burns and no observable effect of RF treatment on filler persistence in the tissue. With monopolar RF treatment, an increase in fibroplasia and collagen deposition surrounding Restylane, Radiesse, and Sculptra was observed. When scored in a blinded fashion, the increase in collagen deposition was statistically significant for Radiesse. CONCLUSIONS: In this animal study, RF treatment had no observed adverse effect on filler collagen responses or persistence. Filler presence did not increase the risk of undesirable thermal effects with monopolar RF treatment. Further clinical studies are required to evaluate the effect of monopolar RF treatment over dermal fillers with respect to aesthetic outcome.