Epithelial separation theory for post-tonsillectomy secondary hemorrhage: evidence in a mouse model and potential heparin-binding epidermal growth factor-like growth factor therapy.

OBJECTIVE: To provide histological evidence to investigate a theory for post-tonsillectomy secondary hemorrhage (PTH) in a mouse model and to evaluate the potential for heparin-binding epidermal growth factor-like growth factor (HB-EGF) treatment on wound healing in this model. METHODS: A prospective randomized single-blinded cohort study. A uniform tongue wound was created in 84 mice (day 0). Mice were randomized to HB-EGF (treatment, n = 42) or saline (control, n = 42). In treatment mice, HB-EGF 5 µg/ml was administered intramuscularly into the wound daily (days 0-14). In control mice, normal saline was administered daily. Three mice from each group were sacrificed daily through day 14 and the wounds evaluated histologically by blinded reviewers. RESULTS: Key stages of wound healing, including keratinocyte proliferation and migration, wound contraction, epithelial separation, and neoangiogenesis, are defined with implications for post-tonsillectomy wound healing. Epithelial separation (59 vs. 100%, p = 0.003) and wound reopening (8 vs. 48%, p < 0.001) were reduced with HB-EGF. Epithelial thickness (220 vs. 30 µm, p = 0.04) was greater with HB-EGF. Wound closure (days 4-5 vs. day 6, p = 0.01) occurred earlier with HB-EGF. CONCLUSIONS: In healing of oral keratinocytes on muscle epithelial separation secondary to muscle, contraction occurs concurrently with neoangiogenesis in the base of the wound, increasing the risk of hemorrhage. This potentially explains why post-tonsillectomy secondary hemorrhage occurs and its timing. HB-EGF-treated wounds showed greater epithelial thickness, less frequent epithelial separation and wound reopening, and earlier wound closure prior to neovascularization, suggesting that HB-EGF may be a potential preventative therapy for PTH. LEVEL OF EVIDENCE: NA-animal studies or basic research.

A novel thermal compression device for perioperative warming: a randomized trial for feasibility and efficacy.

BACKGROUND: Inadvertent perioperative hypothermia (IPH) leads to surgical complications and increases length of stay. IPH rates are high with the current standard of care, forced air warming (FAW). Our hypothesis is that a prototype thermal compression device that heats the popliteal fossa and soles of the feet, with lower leg compression, increases perioperative temperatures and reduces IPH compared to the current standard of care. METHODS: Thirty six female breast surgery patients, at a tertiary academic hospital, were randomized to the device or intraoperative FAW (stage I) with a further 18 patients randomized to the device with a single heating area only (stage II, popliteal fossa or sole of the feet). Stage I: 37 patients recruited (final 36). Stage II: 18 patients recruited (final 18). INCLUSION CRITERIA: general anesthesia with esophageal monitoring for over 30 min, legs available and able to fit the device and no contraindications to leg heating or compression. The intervention was: Stage I: Investigational prototype thermal compression device (full device group) or intraoperative FAW. Stage II: Device with only a single heating location. Primary outcomes were perioperative temperatures and incidence of IPH. Secondary outcomes were local skin temperature, general and thermal comfort scores and presence of perioperative complications, including blood loss. RESULTS: Mean temperatures in the full device group were significantly higher than the FAW group in the pre-operative (36.7 vs 36.4 °C, p < 0.001), early intraoperative (36.3 vs 35.9 °C, p < 0.001), intraoperative (36.6 vs 36.2 °C, p < 0.001) and postoperative periods (36.8 vs 36.5 °C, p < 0.001). The incidence of IPH in the device group was also significantly lower (16.7% vs 72.0%, p = 0.001). Thermal comfort scores were significantly higher in the full device group and hypothermia associated wound complications were higher in the FAW group. CONCLUSIONS: The thermal compression device is feasible and has efficacy over the FAW. Further studies are recommended to investigate clinically significant outcomes. TRIAL REGISTRATION: clinicaltrials.gov ( NCT02155400 ).

No systemic exposure of transtympanic heparin-binding epidermal growth factor like growth factor.

CONTEXT: Heparin-binding epidermal growth factor like growth factor (HB-EGF) is an emerging therapeutic for the regeneration of the tympanic membrane (TM). OBJECTIVE: Our aim was to determine whether the doses of HB-EGF delivered in a sustained release hydrogel into a middle ear mouse model, would be measurable in the systemic circulation. We also aimed to observe, in the scenario that the intended dose was absorbed directly into the circulation, whether these levels could be measured above the background levels of HB-EGF in the circulation. METHODS: A total of 12 mice had transtympanic injections of 5 µg/ml of HB-EGF contained within a previously described novel hydrogel vehicle, while another 12 mice had intravenous delivery of 10 µg/kg of HB-EGF. Intravenous blood samples were collected at 0-, 3-, 24-, 168-, 288- and 720-h post-injection. A double-antibody sandwich one-step process enzyme-linked immunosorbent assay (ELISA) was used to determine the level of HB-EGF in the serum. RESULTS: No mice in the transtympanic administration group and no mice in the intravenous administration group were found to have blood level measured above that in the controls. DISCUSSION: The inability of the positive control to measure levels above background, suggest the total dose used in our studies, even if 100% absorbed into the system circulation is insignificant. CONCLUSIONS: HB-EGF at the doses and delivery method proposed for treatment of chronic TM perforation in a mouse model are likely to have no measurable systemic effect.

CT volumetry for gastric carcinoma: association with TNM stage.

OBJECTIVES: We evaluated the feasibility of performing CT volumetry of gastric carcinoma (GC) and its correlation with TNM stage. METHODS: This institutional review board-approved retrospective study was performed on 153 patients who underwent a staging CT study for histologically confirmed GC. CT volumetry was performed by drawing regions of interest including abnormal thickening of the stomach wall. Reproducibility of tumour volume (Tvol) between two readers was assessed. Correlation between Tvol and TNM/peritoneal staging derived from histology/surgical findings was evaluated using ROC analysis and compared with CT evaluation of TNM/peritoneal staging. RESULTS: Tvol was successfully performed in all patients. Reproducibility among readers was excellent (r = 0.97; P = 0.0001). The median Tvol of GC showed an incremental trend with T-stage (T1 = 27 ml; T2 = 32 ml; T3 = 53 ml and T4 = 121 ml, P < 0.01). Tvol predicted with good accuracy T-stage (≥T2:0.95; ≥T3:0.89 and T4:0.83, P = 0.0001), M-stage (0.87, P = 0.0001), peritoneal metastases (0.87, P = 0.0001) and final stage (≥stage 2:0.89; ≥stage 3:0.86 and stage 4:0.87, P = 0.0001), with moderate accuracy for N-stage (≥N1:0.75; ≥N2:0.74 and N3:0.75, P = 0.0001). Tvol was significantly (P < 0.05) more accurate than standard CT staging for prediction of T-stage, N3-stage, M-stage and peritoneal metastases. CONCLUSION: CT volumetry may provide useful adjunct information for preoperative staging of GC. KEY POINTS: CT volumetry of gastric carcinoma is feasible and reproducible. Tumour volume <19.4 ml predicts T1-stage gastric cancer with 91% sensitivity and 100% specificity (P = 0.0001). Tumour volume >95.7 ml predicts metastatic gastric cancer with 87% sensitivity and 78.5% specificity (P = 0.0001). CT volumetry may be a useful adjunct for staging gastric carcinoma.

Epidemiology of Chronic Suppurative Otitis Media in the United States.

OBJECTIVE: This study aimed to evaluate the prevalence, incidence, and associated demographic factors of chronic suppurative otitis media (CSOM), utilizing a nationwide healthcare claims database. METHODS: This retrospective study utilized outpatient administrative claims data from the IBM MarketScan Research Database from 2007 to 2021. The database (11 246 909 584 claims with 148 147 615 unique patients) includes health data from the private-sector, Medicare/Medicaid, managed care providers, and EMR providers. Included patients had a diagnosis of CSOM based on ICD-9-CM and ICD-10-CM codes. Prevalence and health utilization were estimated by age, gender, and geographic region. RESULTS: In the United States, the estimated CSOM prevalence and incidence was 0.46% and 0.03%, respectively. Among CSOM patients (n = 679 906), mean age (SD) was 8.1 (15.4) years, and 52.8% were male. Most patients (81.1%) were aged 0 to 10 years. CSOM prevalence was lower in females (OR = 0.64, 95% CI 0.64-0.65, P < .001), less common in older age (OR = 0.94, 95% CI 0.94-0.94, P < .001), and highest in the South region (OR = 2.08, 95% CI 2.06-2.09, P < .001). CONCLUSION: Our results show CSOM prevalence (0.46%) is similar to other developed countries. CSOM prevalence was highest in those aged 0 to 10 years, in males and in the South region. Of note, prevalence and cost are likely significantly underestimated given limitations in accurate ICD-CM coding and the exclusion of uninsured patients. Further epidemiological studies are warranted to characterize the impact of CSOM on the US healthcare system.

PANEL 3: Otitis media animal models, cell culture, tissue regeneration & pathophysiology.

OBJECTIVE: To review and summarize recently published key articles on the topics of animal models, cell culture studies, tissue biomedical engineering and regeneration, and new models in relation to otitis media (OM). DATA SOURCE: Electronic databases: PubMed, National Library of Medicine, Ovid Medline. REVIEW METHODS: Key topics were assigned to the panel participants for identification and detailed evaluation. The PubMed reviews were focused on the period from June 2019 to June 2023, in any of the objective subject(s) or keywords listed above, noting the relevant references relating to these advances with a global overview and noting areas of recommendation(s). The final manuscript was prepared with input from all panel members. CONCLUSIONS: In conclusion, ex vivo and in vivo OM research models have seen great advancements in the past 4 years. From the usage of novel genetic and molecular tools to the refinement of in vivo inducible and spontaneous mouse models, to the introduction of a wide array of reliable middle ear epithelium (MEE) cell culture systems, the next five years are likely to experience exponential growth in OM pathophysiology discoveries. Moreover, advances in these systems will predictably facilitate rapid means for novel molecular therapeutic studies.

Bicycle-Related Injuries of the Upper Extremity.

Background: In recent years, the increasing popularity of cycling for commuting and leisure has led to a corresponding increase in bicycle-related injuries. However, there is a lack of extensive analysis of bicycle-related injuries to the upper limb in the literature. Methods: A retrospective review of all patients with conventional bicycle-related injuries of the upper limb was performed. Data on demographics, mechanisms of injury, region of injury, fracture type, management type, and length of hospital stay were extracted and analyzed. Results: A total of 177 of 733(24%) patients with bicycle-related upper limb injuries were identified. The most common mechanism of injury was a collision with another vehicle (60%). Frequently affected regions were the shoulder (48%), hand (19%), and wrist (19%). Eighty-eight (50%) patients sustained bony injuries, while the remainder (50%) had isolated soft tissue injuries. Fifty-three (30%) patients required a mean of 3.9 days of hospitalization, whereas 13 (25%) patients required high dependency or intensive care unit treatment. Surgical interventions were required in 47 (27%) patients. Conclusion: Bicycle-related injuries to the upper limb are common and result in significant morbidity. The most common regions affected are the shoulder, wrist, and hand. Most of the injuries were caused by collisions with other vehicles. A third of affected patients required hospitalization, and a quarter required surgical intervention.

Minimally invasive trans-tympanic eustachian tube occlusion animal model.

OBJECTIVE: Eustachian tube dysfunction is believed to be involved in the pathogenesis of many middle ear diseases including chronic suppurative otitis media. We aimed to describe a simple and reliable animal model of Eustachian Tube obstruction to further research into middle ear disorders. STUDY DESIGN: Prospective cohort study in animals. SETTING: University laboratory. SUBJECTS AND METHODS: 30 mice C57Bl/6J (n = 15) and CBA/CaJ (n = 15) aged 6-8 weeks received transtympanic Eustachian tube occlusion on left ear trough an acute tympanic membrane perforation using thermoplastic latex used in dental procedures (gutta percha). Control mice (n = 6) received tympanic membrane perforation only. At two and four weeks, the mice were observed for signs of Eustachian tube dysfunction and compared to control ears. ET dysfunction was defined as presence of effusion in the middle ear. RESULTS: 100% (n = 30) of the treated ears had otoscopic signs of Eustachian tube dysfunction at two weeks and the endpoint time of four weeks, compared to 0% in control mice (0/6). Temporary head tilt lasting up to 2 days were observed in 3 mice (10%). No other potential adverse events were recorded. No bacterial growth was determined in the middle ear fluid. CONCLUSION: We describe a technically easy and reliable method for Eustachian tube occlusion in mice with an excellent success rate and minimal morbidity.

Middle Cranial Fossa Approach to Repair Tegmen Dehiscence Using Self-setting Calcium Phosphate Cement: A Retrospective Case Review.

OBJECTIVES: To review the outcomes of repairing tegmen dehiscence using the middle cranial fossa approach with a self-setting bone cement. STUDY DESIGN: Retrospective case series. SETTING: Two academic tertiary hospitals. PATIENTS: All patients presenting for surgical repair of tegmen dehiscence and with postoperative follow-up for at least 6 months between October 2015 and July 2019. INTERVENTION: Surgical repair using a middle cranial fossa approach using a layered reconstruction with temporalis fascia and self-setting calcium phosphate bone cement. MAIN OUTCOME MEASURES: Perioperative complications, recurrence of presenting symptoms/disease, hearing, and facial nerve grade. RESULTS: The cohort consisted of 22 patients with 23 tegmen dehiscence repairs (1 sequential bilateral repair). There were 16 males and 6 females with an average age at operation of 52.6 years. Repairs were left sided in 9, right sided in 12 patients, and bilateral in 1 patient. No patients had recurrence of presenting symptoms or disease at most recent follow-up. Preoperative hearing was maintained in all patients. Two patients (9% of repairs) experienced delayed partial temporary facial nerve weakness House-Brackman grade 2 and 4 which had recovered by 8 weeks postoperative. CONCLUSION: We demonstrate a technique for repairing tegmen dehiscence of the middle cranial fossa floor that has excellent postoperative outcomes. We highlight potential technical challenges in this approach as well as the need for counseling for potential partial transient facial nerve dysfunction.

A design-thinking approach to therapeutic translation: tympanic regeneration.

PURPOSE OF REVIEW: Clinician researchers face the pressures of meeting academic benchmarks combined with advancing new therapies to patients. The vast majority of drug discoveries fail in translation. A new method of meeting the challenges of preclinical therapeutic translation is presented using the example of tympanic regeneration. RECENT FINDINGS: The key to a design-thinking approach to therapeutic translation is to 'begin with the end in mind' by widening the scope of the problem, with multiple points of view, to not only understand the disease but the context for the patient and the health system in which it occurs. Idea for therapeutics should be tested in relevant models early and once proof of efficacy is established, translational milestones that represent the greatest risk, such as safety and toxicity should be addressed first. It is important to seek the feedback of industry early to understand what milestones should be best addressed next with limited academic resources. Whenever proceeding, guidelines for maintaining scientific reproducibility should be followed to minimize risk of failure during transfer into industry. SUMMARY: A Design-thinking approach addresses the potential failures in drug discovery and preclinical translation.

A Review of the Contribution of Mast Cells in Wound Healing: Involved Molecular and Cellular Mechanisms.

Mast cells (MCs), apart from their classic role in allergy, contribute to a number of biologic processes including wound healing. In particular, two aspects of their histologic distribution within the skin have attracted the attention of researchers to study their wound healing role; they represent up to 8% of the total number of cells within the dermis and their cutaneous versions are localized adjacent to the epidermis and the subdermal vasculature and nerves. At the onset of a cutaneous injury, the accumulation of MCs and release of proinflammatory and immunomodulatory mediators have been well documented. The role of MC-derived mediators has been investigated through the stages of wound healing including inflammation, proliferation, and remodeling. They contribute to hemostasis and clot formation by enhancing the expression of factor XIIIa in dermal dendrocytes through release of TNF-α, and contribute to clot stabilization. Keratinocytes, by secreting stem cell factor (SCF), recruit MCs to the site. MCs in return release inflammatory mediators, including predominantly histamine, VEGF, interleukin (IL)-6, and IL-8, that contribute to increase of endothelial permeability and vasodilation, and facilitate migration of inflammatory cells, mainly monocytes and neutrophils to the site of injury. MCs are capable of activating the fibroblasts and keratinocytes, the predominant cells involved in wound healing. MCs stimulate fibroblast proliferation during the proliferative phase via IL-4, vascular endothelial growth factor (VEGF), and basic fibroblast growth factor (bFGF) to produce a new extracellular matrix (ECM). MC-derived mediators including fibroblast growth factor-2, VEGF, platelet-derived growth factor (PDGF), TGF-ß, nerve growth factor (NGF), IL-4, and IL-8 contribute to neoangiogenesis, fibrinogenesis, or reepithelialization during the repair process. MC activation inhibition and targeting the MC-derived mediators are potential therapeutic strategies to improve wound healing through reduced inflammatory responses and scar formation.

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2019.

OBJECTIVE: To review new devices and drugs relevant to otolaryngology-head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2019. DATA SOURCES: Approval notifications for 2019 were extracted from the ENT (ear, nose, and throat) and general and plastic surgery sections of the FDA's medical devices and therapeutics listings. REVIEW METHODS: New therapeutics and medical devices identified from the query were analyzed by members of the American Academy of Otolaryngology-Head and Neck Surgery's Medical Devices and Drugs Committee. Technologies were assessed by 2 independent reviewers to ascertain relevance to otolaryngology, prioritized, and classified to subspecialty field with critical review based on extant scientific literature. CONCLUSIONS: Query of the FDA drug and device database returned 105 ENT devices (50 cleared, 55 with premarket approval, and 0 de novo), 543 general and plastic surgery devices (372 cleared, 170 with premarket approval, and 1 de novo), and 46 new otolaryngology-relevant drug approvals that occurred in 2019. Advances spanned all subspecialty areas with otology predominating, primarily due to hearing-related technologies. While scientific evidence was available for all new devices, there was significant heterogeneity in rigor of supporting scientific data. IMPLICATIONS FOR PRACTICE: Technological and pharmaceutical innovation is an important catalyst for advances in the surgical specialties. Familiarity with new devices and therapeutics in otolaryngology-head and neck surgery ensures that clinicians keep abreast of developments with potential to improve prevailing standards of care.

Age-Related Hearing Loss: Innovations in Hearing Augmentation.

Age-related hearing loss is a multifactorial condition that affects more than one-third of the aging population. Left untreated it can increase the risk of cognitive decline, dementia, social isolation, depression, and falls. Hearing augmentation devices exhibit improved digital sound processing and Smartphone connectivity. Stigma remains one of the prominent barriers and todays devices offer in the canal models, miniature sizes, and camouflage with the hair or skin color. Although rigorous scientific efforts are made in the research field of inner ear regeneration and some clinical early phase studies do exist, to date, the clinical availability is still some time away.

Optical Coherence Tomography of the Tympanic Membrane and Middle Ear: A Review.

Objective To evaluate the recent developments in optical coherence tomography (OCT) for tympanic membrane (TM) and middle ear (ME) imaging and to identify what further development is required for the technology to be integrated into common clinical use. Data Sources PubMed, Embase, Google Scholar, Scopus, and Web of Science. Review Methods A comprehensive literature search was performed for English language articles published from January 1966 to January 2018 with the keywords "tympanic membrane or middle ear,""optical coherence tomography," and "imaging." Conclusion Conventional imaging techniques cannot adequately resolve the microscale features of TM and ME, sometimes necessitating diagnostic exploratory surgery in challenging otologic pathology. As a high-resolution noninvasive imaging technique, OCT offers promise as a diagnostic aid for otologic conditions, such as otitis media, cholesteatoma, and conductive hearing loss. Using OCT vibrometry to image the nanoscale vibrations of the TM and ME as they conduct acoustic waves may detect the location of ossicular chain dysfunction and differentiate between stapes fixation and incus-stapes discontinuity. The capacity of OCT to image depth and thickness at high resolution allows 3-dimensional volumetric reconstruction of the ME and has potential use for reconstructive tympanoplasty planning and the follow-up of ossicular prostheses. Implications for Practice To achieve common clinical use beyond these initial discoveries, future in vivo imaging devices must feature low-cost probe or endoscopic designs and faster imaging speeds and demonstrate superior diagnostic utility to computed tomography and magnetic resonance imaging. While such technology has been available for OCT, its translation requires focused development through a close collaboration between engineers and clinicians.

The long and short of cephalomedullary nails in the treatment of osteoporotic pertrochanteric fracture.

INTRODUCTION: Pertrochanteric fractures after low-energy trauma are common among osteoporotic patients. Although the use of intramedullary devices to treat such fractures is becoming increasingly popular, there is a paucity of data comparing the outcomes of the use of short cephalomedullary nails (SCN) with the use of long cephalomedullary nails (LCN). This study aimed to compare the outcomes of treatment using LCN with treatment using SCN for patients with osteoporotic pertrochanteric fractures. METHODS: A retrospective review of 64 patients with osteoporotic pertrochanteric fractures who were treated with either LCN or SCN and had a minimum follow-up of one year was performed. Primary outcome measures include complications, revision surgeries and union rates. Secondary outcome measures include duration of surgery, estimated blood loss, length of hospital stay, and ambulatory and mortality status at one year. RESULTS: There was no significant difference in the clinical and functional outcomes of the patients who were treated with LCN and those who were treated with SCN. However, there was a higher incidence of heterotopic ossification in the latter group, and a slightly greater average estimated blood loss and duration of surgery in the former group. Patients treated with LCN tended to be more osteoporotic. CONCLUSION: Our study found no significant difference in terms of complications, revision surgeries, union rates and ambulatory status between the patients who were treated with LCN and those who were treated with SCN. Both LCN and SCN provided safe and reliable outcomes in the treatment of osteoporotic pertrochanteric fractures.

Functional Outcomes of Heparin-Binding Epidermal Growth Factor-Like Growth Factor for Regeneration of Chronic Tympanic Membrane Perforations in Mice.

We aim to demonstrate that regeneration of chronic tympanic perforations with heparin-binding epidermal growth factor-like growth factor (HB-EGF) delivered by an injectable hydrogel restored hearing to levels similar to that of nonperforated tympanic membranes. Chronic tympanic membrane perforation is currently managed as an outpatient surgery with tympanoplasty. Due to the costs of this procedure in the developed world and a lack of accessibility and resources in developing countries, there is a great need for a new treatment that does not require surgery. In this study, we show in a mouse model through measurement of auditory brainstem response and distortion product otoacoustic emissions that tympanic perforations lead to hearing loss and this can be predominantly recovered with HB-EGF treatment (5 µg/mL). Our animal model suggests a return to function between 2 and 6 months after treatment. Auditory brainstem response thresholds had returned to the control levels at 2 months, but the distortion product otoacoustic emissions returned between 2 and 6 months. We also show how the vibration characteristics of the regenerated tympanic membrane, as measured by laser Doppler vibrometry, can be similar to that of an unperforated tympanic membrane. Using the best available methods for preclinical evaluation in animal models, it is likely that HB-EGF-like growth factor treatment leads to regeneration of chronic tympanic membrane perforations and restoration of the tympanic membrane to normal function, suggesting a potential route for nonsurgical treatment.

Biomedical device innovation methodology: applications in biophotonics.

The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a "to market" strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

Combined Approach to Phacoemulsification and Trabeculectomy Results in Less Ideal Refractive Outcomes Compared With the Sequential Approach.

PURPOSE: To compare the refractive outcomes of combined versus sequential trabeculectomy and then phacoemulsification. METHODS: We compared eyes that underwent uncomplicated combined phacotrabeculectomy (combined group, 87 eyes), phacoemulsification at least 3 months after trabeculectomy (sequential group, 56 eyes), and phacoemulsification only (control group, 78 eyes) between January 1, 2006 and January 1, 2014. The main outcome measure was refractive prediction error (RPE)-defined as postoperative subjective spherical equivalent refraction minus predicted spherical equivalent refraction. RESULTS: The study population was predominantly Chinese and the mean age at their cataract surgery was 67.2±9.59 years. Compared with controls, RPE (-0.40±0.70 vs. -0.01±0.50, P<0.001) and mean absolute error (0.62±0.50 vs. 0.39±0.31, P=0.003) were greater for the combined group but not for the sequential group. Proportionately fewer patients in the combined group achieved final subjective refraction within ±0.5D (27.6% vs. 46.2%, P=0.01) compared with controls. Within the sequential group, there were no differences in RPE when the fellow eye axial length was used to predict refractive outcome (P=0.17) or between the group with precataract surgery IOPs of ≤11 mm Hg (-0.28±0.82) and the group with >11 mm Hg (-0.28±0.53, P=0.99). For the sequential group, the use of contact A scan yielded less RPE compared with IOLMaster (P=0.01). CONCLUSIONS: Combined approach to trabeculectomy and phacoemulsification resulted in greater myopic RPEs that were expectedly greater than those found in the phacoemulsification group.

Temporal-Bone Measurements of the Maximum Equivalent Pressure Output and Maximum Stable Gain of a Light-Driven Hearing System That Mechanically Stimulates the Umbo.

HYPOTHESIS: That maximum equivalent pressure output (MEPO) and maximum stable gain (MSG) measurements demonstrate high output and high gain margins in a light-driven hearing system (Earlens). BACKGROUND: The nonsurgical Earlens consists of a light-activated balanced-armature transducer placed on the tympanic membrane (Lens) to drive the middle ear through direct umbo contact. The Lens is driven and powered by encoded pulses of light. In comparison to conventional hearing aids, the Earlens is designed to provide higher levels of output over a broader frequency range, with a significantly higher MSG. MEPO provides an important fitting guideline. METHODS: Four fresh human cadaveric temporal bones were used to measure MEPO directly. To calculate MEPO and MSG, we measured the pressure close to the eardrum and the stapes velocity, for sound drive and light drive using the Earlens. RESULTS: The baseline sound-driven measurements are consistent with previous reports. The average MEPO (n = 4) varies from 116 to 128 dB SPL in the 0.7 to 10 kHz range, with the peak occurring at 7.6 kHz. From 0.1 to 0.7 kHz, it varies from 83 to 121 dB SPL. For the average MSG, a broad minimum of about 10 dB occurs in the 1 to 4 kHz range, above which it rises as high as 42 dB at 7.6 kHz. From 0.2 to 1 kHz, the MSG decreases linearly from approximately 40 dB to 10 dB. CONCLUSION: With high output and high gain margins, the Earlens may offer broader-spectrum amplification for treatment of mild-to-severe hearing impairment.