Hemorrhage Following Muller's Muscle Conjunctival Resection: Description and Case-Control Study.

PURPOSE: The purpose of this study was to report a series of patients with postoperative hemorrhage after Muller's muscle conjunctival resection surgery and compare risk factors and outcomes with a control population. METHODS: In this case-control study, records of patients who underwent Muller's muscle conjunctival resection over 5 years were reviewed for a history of postoperative hemorrhage occurring >24 hours after surgery. A 4:1 control population was matched for age and sex. Clinical data collected included demographics, medical history, medications, and subsequent surgery. Preoperative and 3-month postoperative marginal reflex distance 1 were measured digitally using ImageJ. The hemorrhage and control groups were compared using Fisher's exact tests for categorical variables and independent samples t tests for continuous variables. RESULTS: The hemorrhage group contained 10 patients (mean age 66.4 ± 18.5 years). The control group consisted of 40 age and sex-matched controls. Of 350 charts reviewed, there were 10 cases of postoperative hemorrhage (incidence 2.9%). Hemorrhage occurred a mean of 4.2 ± 1.3 (range 2-7) days after surgery and lasted for a mean of 29.3 ± 19.1 (range 12-72) hours. In all 10 cases, the bleeding resolved with conservative measures. There was no difference between the hemorrhage and control groups in terms of medical conditions, blood thinners, and surgical revision. Preoperative, postoperative, and change in marginal reflex distance 1 did not differ between the hemorrhage and control groups. CONCLUSIONS: Hemorrhage occurs approximately 4-5 days postoperatively in a small percentage of patients undergoing Muller's muscle conjunctival resection surgery. This investigation did not identify any consistent risk factors, and outcomes in this patient population appear no different than controls.

Combination endoscopic surgical debridement and transcutaneous retrobulbar amphotericin B for acute rhino-orbital-cerebral aspergillosis.

Purpose: To report a case of acute rhino-orbital-cerebral aspergillosis with aggressive intracranial and orbital extension co-managed medically and surgically with endoscopic sinus debridement and multiple retrobulbar injections of amphotericin B. Observations: A 70-year-old male patient presented via external transfer with headaches and left ophthalmoplegia concerning for severe complicated sinusitis with intracranial and left orbital spread. His history is notable for a simultaneous heart-kidney transplant three years prior on chronic immunosuppression. Ophthalmologic examination revealed complete ophthalmoplegia in the left eye with no light perception concerning for a left orbital apex syndrome. The patient was taken to the operating room twice for endoscopic sinus debridement and three separate retrobulbar injections of amphotericin B. Fungal cultures from surgical specimens grew isolated Aspergillus fumigatus. Patient's symptoms gradually improved and repeat MRI demonstrated resolution of pansinusitis, sparing left eye exenteration. Conclusions and importance: Multidisciplinary management of invasive fungal rhinosinusitis in the setting of profound immunosuppression poses a significant challenge. While surgical debridement remains the cornerstone approach, the achievable reduction in disease burden may be augmented by targeted retrobulbar antimicrobials.

The CRW1 Index: Identification of Eyes with Previous Myopic Laser Vision Correction Using Only a Swept-Source OCT Biometer.

PURPOSE: To develop and test a novel index (Cooke-Riaz-Wendelstein [CRW1]) that uses swept-source optical coherence tomography (SS-OCT) biometry measurements (IOLMaster700, Zeiss Meditec), including total keratometry, to alert clinicians that previous myopic laser vision correction (M-LVC) was present in a measured eye. DESIGN: Retrospective, multicenter, comparative diagnostic analysis. METHODS: The study took place at 6 centers in the United States and Austria. Anonymized SS-OCT biometry datasets acquired between 2018 and 2020 and containing 49,199 eyes were analyzed. The LVC status, as identified by the biometrist, was used to segregate eyes into LVC and non-LVC eyes. Data were split into training (10,780 eyes) and validation (38,419 eyes) sets. Subset analysis was performed for CRW1 Index accuracy compared to posterior/anterior corneal curvature ratio (Rpost/Rant), topography with corneal analysis software (Atlas 9000 with Pathfinder II, Zeiss Meditec), tomography (Pentacam, Oculus), dual Scheimpflug-Placido system (Galilei G6, Ziemer), and a cloud-based platform for cataract surgery planning (Veracity, Zeiss Meditec). A positive predictive value (PPV) of ≥90% was targeted for the CRW1 index. True positives, true negatives, sensitivity, and specificity were recorded. RESULTS: The CRW1 Index compared favorably against Rpost/Rant showing a higher PPV (93% vs 65%), with fewer false-positive results (29 vs 180). CRW1 performed similarly to topography software and better than the corneal imaging devices. The CRW1 cutoff value can be adjusted to increase sensitivity (CRW1-IS) to detect additional M-LVC eyes. CONCLUSIONS: The CRW1 and CRW1-IS indices offer surgeons and researchers a readily accessible method to use only SS-OCT biometry measurements to detect eyes with a high probability of previous M-LVC.

Anterior openbite malocclusion in adults.

OBJECTIVES: To investigate stability and satisfaction in adult anterior open bite (AOB) patients at least 9 months post-treatment, as well as patient and practitioner factors that may be associated with stability and satisfaction. MATERIALS AND METHODS: Practitioners and their adult AOB patients were recruited through the National Dental Practice-Based Research Network. Data on patient and practitioner characteristics, treatment recommendations and factors were previously collected. Treatment stability was determined by assessing post-treatment intraoral photographs. Patient satisfaction was determined from post-treatment questionnaires. Treatment was categorized into aligners, fixed appliances, temporary anchorage devices, and orthognathic surgery. Extractions were also investigated. Retention type was categorized into vacuum-formed, Hawley-style, or bonded retainers, and regimens were classified as full-time or part-time wear. RESULTS: Retention data collected from 112 patients had a mean post-treatment time of 1.21 years. There were no statistically significant differences in stability between treatment groups. Depending on whether a qualitative index or a millimetric measure was employed, stability ranged from 65% to 89%. Extractions and less initial lower incisor proclination were associated with higher stability in patients treated with fixed appliances only. High satisfaction was reported by patients at retention. There were no clear differences in stability or satisfaction among retention types or regimens. CONCLUSIONS: The stability of adult AOB orthodontic treatment was high, regardless of treatment or retainer modality. Satisfaction in adult AOB patients was high, regardless of retention type or regimen.

Ophthalmic Drug Discovery in the United States over the past Two Decades.

PURPOSE: Pharmaceutical development has slowed since the turn of the century and there has been recent legislation passed that aims to accelerate drug approval. Ophthalmic drug discovery has unique challenges that may benefit from these legislative changes. We report original pharmaceutical approvals for ophthalmic indications in order to determine whether ophthalmic drug approvals are similarly decreasing. METHODS: This observational study extracted all original drug approvals for ocular use from the publicly available Drugs@FDA database from January 1st, 2000 through December 31st, 2019. Drug approvals included new molecular entities, biologic license applications, as well as reformulations, combinations and new indication approvals. Data mined from each approval included: approval date, active ingredient, manufacturer, new drug application classification type, priority or standard review, and orphan drug status. Data were analyzed in four 5-year time periods. RESULTS: A total of 99 ophthalmic agents were approved for ocular use during the study period. On average, drug approvals rose by 2.2 approvals per 5-year quartile. Out of these, new molecular entities and biologics constituted 22% of all drug approvals and fell at an average rate of 0.4 approvals per quartile. CONCLUSION: The majority of ophthalmic drug approvals represented reformulations of prior pharmaceuticals. In line with the overall industry, new molecular entities and novel biologics fell on average during the study period. Legislation that aims to ease challenges to drug approval may be beneficial to increase novel therapeutic development but should be weighed against the risks of decreased patient safety or drug efficacy.

Left atrial size and strain in elite athletes: A cross-sectional study at the NBA Draft Combine.

INTRODUCTION: Atrial dilatation is common but of unclear physiologic significance in high-performance athletes. Myocardial deformation analysis utilizing speckle-tracking echocardiography has emerged as a promising tool to evaluate atrial function. In a cohort of elite basketball players attending the National Basketball Association (NBA) Draft Combine, we investigate changes in left atrial (LA) size as well as function as measured by strain. METHODS AND RESULTS: From 2013 to 2018, all male athletes who attended the NBA Draft Combine in Chicago, IL, received a cardiac evaluation including a comprehensive transthoracic echocardiogram. Using the P-wave as the reference point, speckle-tracking was utilized to measure LA booster, conduit, and reservoir strain over one cardiac cycle. Left atrial volume index (LAVI) of ≥34 mL/m2 was considered enlarged. 307 athletes received cardiac evaluation including a transthoracic echocardiogram, with 272 studies amenable for atrial strain analysis. Mean age was 21.0 years. Mean LAVI was 34.5 mL/m2 and LAVI was enlarged in 131 (48.2%) athletes. Comparing LA strain in those with enlarged vs normal sized atria, reservoir strain was significantly reduced (32.1% [SD 6.0%] vs 35.2% [SD 8.2%], P < .001), as was conduit strain (22.9% [SD 5.2%] vs 25.7% [SD 7.4%], P < .001), with no difference seen in booster strain (9.2% [SD 2.1%] vs 9.4% [SD 2.7%], P = .45). CONCLUSION: In this group of elite basketball players, LA enlargement was common and associated with reduced LA reservoir and conduit strain, with no difference in LA booster strain.

Nonmydriatic Retinal Diabetic Screening in the Primary Care Setting: Assessing Degree of Retinopathy and Incidence of Nondiabetic Ocular Diagnoses.

Purpose: To study the rates and severity of diabetic retinopathy (DR), rates of nondiabetic ocular disease, and rates of referral to eye care providers in the context of nonmydriatic retinal screening performed in primary care and endocrinology clinics. Materials and Methods: This study is a retrospective chart review of patients who had nonmydriatic retinal imaging in the primary care setting. Presence and severity of DR as well as detection of nondiabetic ocular diseases were analyzed. Referral rates for different types of pathology were determined. Results: A total of 324 patients were imaged and 294 (90.7%) had gradable images. Mild DR was found in at least one eye of 71 (24.1%) patients, moderate in 20 (6.8%), severe in 3 (1.0%), and proliferative DR in 2 (0.6%). Macular edema was found in 13 (4.4%) patients. Nondiabetic ocular diseases were suspected in 106 (36.1%) patients. The most prevalent findings included glaucoma suspect (10.9%), age-related macular degeneration suspect (8.8%), and hypertensive retinopathy (5.4%). Seventy (23.8%) patients were referred to an eye care provider for DR, 66 (22.4%) were referred for nondiabetic eye disease, and 21 (7.1%) were referred for both. Conclusion: One-third of patients were found to have some degree of DR. Suspected nondiabetic disease or other pathologies were found in one-third of the study population. Referral for examination by an eye care provider was recommended for approximately half of the patients.

Clinical Trials in Obstructive Sleep Apnea: Recognizing Trends and Future Opportunities.

OBJECTIVES/HYPOTHESIS: Examine US and international clinical trials in obstructive sleep apnea (OSA) to characterize researchers involved, interventions being studied, and opportunities for future investigation. STUDY DESIGN: Retrospective database review. METHODS: The information from ClinicalTrials.gov was used to assess OSA clinical trials between 1999 and 2017. Information was gathered on principle investigator (PI) demographics, interventions studied, study funding source, and regional distribution of research institutions. RESULTS: There were 813 clinical trials studied. The majority of trials examined continuous positive airway pressure interventions (43.7%), with pharmacotherapies being the second most commonly investigated treatment (19.2%). Surgical interventions made up 10.7% (n = 87) of clinical trials for OSA. Most studies were based internationally (59.9%). PIs were predominantly male (72.0%); 72.7% had an MD and 28.6% had a PhD. There were no significant differences in funding source (National Institutes of Health vs. industry, P = .14) or institutional geography (international vs. US, P = .73) between surgical and nonsurgical studies. Surgical trials were significantly more likely to have a male PI and involve pediatric patients compared to nonsurgical trials (P < .001). Otolaryngologists represented 9.2% of all PIs and had similar rates of NIH funding compared to other medical specialists (P = .22). CONCLUSIONS: This study provides a broad overview of past, current, and future treatment paradigms for OSA. Sleep surgery, specifically otolaryngology, is a small voice in the overall landscape of clinical trials for OSA. This information can help guide future research efforts and direct our specialty when setting priorities regarding research funding while encouraging a broad and interdisciplinary pursuit. LEVEL OF EVIDENCE: NA Laryngoscope, 129:1940-1944, 2019.

Adverse childhood experiences and smoking persistence in adults with smoking-related symptoms and illness.

OBJECTIVES: Little is known about why people continue to smoke after learning that they have diseases and conditions that contraindicate smoking. Using data from the Adverse Childhood Experiences (ACE) Study, we examined the relation between ACEs and smoking behavior when smoking-related illnesses or conditions are present, both with and without depression as a mediator. METHODS: Participants were more than 17,000 adult HMO members who retrospectively reported on eight categories of ACEs (emotional, physical, and sexual abuse; witnessing interparental violence; parental divorce; and growing up with a substance-abusing, mentally ill, or incarcerated household member). The number of maltreatment categories was summed to form an ordinal variable called the ACE Score. We measured current smoking, conditions that contraindicate smoking (heart disease, chronic lung disease, and diabetes), and symptoms of these illnesses (chronic bronchitis, chronic cough, and shortness of breath). Logistic regression models compared the ACE Score of smokers with smoking-related illnesses to participants who reported these illnesses but were not current smokers (n = 7483). RESULTS: Significant dose-response relations between the ACE Score and smoking persistence were found (odds ratio = 1.69; confidence interval = 1.34-2.13 for participants with ≥4 ACEs). Depression was a significant independent predictor of smoking persistence as well as a mediator. Depression only slightly attenuated the relation between the ACE Score and persistent smoking, however. CONCLUSION: Medical practitioners should consider the maltreatment history and depression status of their patients when a smoking-related diagnosis fails to elicit smoking cessation. Programs should be developed that better address the underlying motivations for continuing to smoke in the face of health problems that contraindicate smoking.

Diarrheal disease on cruise ships, 1990-2000: the impact of environmental health programs.

BACKGROUND: In 1975, the then-Center for Disease Control (CDC) established the Vessel Sanitation Program (VSP) to minimize the risk for diarrheal disease among passengers and crew aboard ships by assisting the cruise ship industry in developing and implementing comprehensive environmental health programs. OBJECTIVES: To evaluate the relationship between cruise ship sanitation scores and diarrheal disease incidence and outbreaks among cruise ship passengers. METHODS: Retrospective cohort study of ship inspection and diarrheal disease data from 1990 through 2000 from the National Center for Environmental Health, CDC database, for cruise ships entering the United States. OUTCOMES: Yearly trends in number of ships inspected, number of inspections conducted, inspection scores, and risks of failing inspections; rates of diarrheal disease among passengers, by inspection year, cruise duration, incidence of outbreaks, and passing- or failing-score status of the associated ship. RESULTS: From 1990 through 2000, inspection scores gradually increased from a median of 89 in 1990 to 93 in 2000 (p<0.001), with an associated statistically significant 21% increase in likelihood of passing. The total baseline level of diarrhea among passengers was 2.0 cases per cruise (13243/6485), or 23.6 cases per 100,000 passenger-days (13243/56129096). The latter rate declined significantly from 29.2 in 1990 to 16.3 in 2000 (p<0.0001). Diarrheal disease incidence rates among passengers sailing on ships that passed environmental inspections were significantly lower than rates among passengers sailing on ships that failed inspections (21.7 vs 30.1; RR = 1.39; 95% CI: 1.31-1.47). Diarrheal disease outbreak-related illnesses decreased from 4.2 to 3.5 per 100000 passenger-days from 1990-1995 to 1996-2000. CONCLUSIONS: Environmental sanitation inspections conducted among ships sailing into the United States appear to continue to decrease diarrheal disease rates and outbreaks among passengers.

Childhood vaccinations and risk of asthma.

BACKGROUND: A few previous studies have suggested that childhood vaccines, particularly whole cell pertussis vaccine, may increase the risk of asthma. We evaluated the suggested association between childhood vaccinations and risk of asthma. METHODS: Cohort study involving 167,240 children who were enrolled in 4 large health maintenance organizations during 1991 to 1997, with follow-up from birth until at least 18 months to a maximum of 6 years of age. Vaccinations were ascertained through computerized immunization tracking systems, and onset of asthma was identified through computerized data on medical care encounters and medication dispensings. RESULTS: In the study 18,407 children (11.0%) developed asthma, with a median age at onset of 11 months. The relative risks (95% confidence intervals) of asthma were: 0.92 (0.83 to 1.02) for diphtheria, tetanus and whole cell pertussis vaccine; 1.09 (0.9 to 1.23) for oral polio vaccine; 0.97 (0.91 to 1.04) for measles, mumps and rubella (MMR) vaccine; 1.18 (1.02 to 1.36) for Haemophilus influenzae type b (Hib); and 1.20 (1.13 to 1.27) for hepatitis B vaccine. The Hib result was not consistent across health maintenance organizations. In a subanalysis restricted to children who had at least 2 medical care encounters during their first year, the relative risks decreased to 1.07 (0.71 to 1.60) for Hib and 1.09 (0.88 to 1.34) for hepatitis B vaccine. CONCLUSION: There is no association between diphtheria, tetanus and whole cell pertussis vaccine, oral polio vaccine or measles, mumps and rubella vaccine and the risk of asthma. The weak associations for Hib and hepatitis B vaccines seem to be at least partially accounted for by health care utilization or information bias.