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PURPOSE: The purpose of this study is to quantify cancer risk in patients with Fuchs endothelial corneal dystrophy (FECD). METHODS: Using the 2014 to 2016 Medicare Limited 5% Data Sets-Carrier Line File, US Medicare fee-for-service beneficiaries (aged 65 years or older) with FECD and cancer were identified through International Classification of Diseases , ninth and 10th Revision diagnostic codes from January 1, 2014, to December 31, 2016. The main outcome measures were odds ratios (ORs) of cancer at various anatomic locations in patients with versus without FECD. RESULTS: Of the 1,462,740 Medicare beneficiaries, 15,534 patients (1.1%) had an International Classification of Disease code for FECD. Compared with US Medicare beneficiaries without FECD, patients with FECD were at increased risk for the following malignancies: breast [OR: 1.32; 95% confidence interval (CI): 1.22-1.43; P < 0.001], cutaneous basal cell (OR: 1.42; 95% CI: 1.35-1.49; P < 0.001), cutaneous melanoma (OR: 1.20; 95% CI: 1.03-1.40; P = 0.02), cutaneous squamous cell (OR: 1.45; 95% CI: 1.38-1.53; P < 0.001), ovarian (OR: 1.84; 95% CI: 1.48-2.30; P < 0.001), and thyroid (OR: 1.32; 95% CI: 1.04-1.68; P = 0.02). By contrast, FECD cases were at lower odds of having lung (OR: 0.81; 95% CI: 0.71-0.93; P = 0.003) and prostate cancer diagnoses (OR: 0.88; 95% CI: 0.81-0.96; P = 0.002). CONCLUSIONS: Patients with FECD aged 65 years or older may be at increased risk for cancer at several anatomic locations. Follow-up studies are needed to further explore the association of FECD and malignancy, elucidate potential disease mechanisms, and identify genetic and/or environmental risk factors.
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Distrofia Endotelial de Fuchs , Melanoma , Neoplasias Cutáneas , Anciano , Endotelio Corneal/patología , Estudios de Seguimiento , Distrofia Endotelial de Fuchs/diagnóstico , Humanos , Masculino , Medicare , Melanoma/patología , Neoplasias Cutáneas/patología , Estados Unidos/epidemiologíaRESUMEN
PURPOSE: To use optical modeling to compare a 6.0 mm and 7.0 mm intraocular lens (IOL) optic diameters on peripheral retinal illumination with implications for negative dysphotopsia. SETTING: Mayo Clinic, Rochester, Minnesota, and Simpson Optics LLC, Arlington, Texas. DESIGN: Model eye. METHODS: Ray-tracing software was used to simulate retinal illumination from an extended light source for a pseudophakic eye with in-the-bag biconvex IOLs (refractive index [n] = 1.46 and 1.55) and a 2.5 mm pupil. Ray-tracing diagrams and simulated retina illumination profiles were compared using the 6.0 mm and 7.0 mm optic diameter IOLs. Retinal locations were scaled to relative visual angles from 70 to 110 degrees horizontally. RESULTS: A 7.0 mm optic (n = 1.46) expands the image field by 2.8 degrees compared with a 6.0 mm optic. High-angle input light misses a 7.0 mm optic at a larger visual angle than a 6.0 mm optic, shifting illumination of the peripheral retina by this light anteriorly by 5.6 degrees. Consequently, a region of nonilluminated peripheral nasal retina is enlarged and shifted peripherally using a 7.0 mm optic (visual angle, 86.3 to 96.3 degrees) compared with a 6.0 mm optic (visual angle, 83.5 to 90.7 degrees). Similar illumination changes were seen modeling a 1.55 n IOL. CONCLUSIONS: A narrow dark region in the nasal retina when using a 6.0 mm optic is changed to a broader, more peripheral dark region when using a 7.0 mm optic. An extended, more peripheral dark nasal region may make a temporal shadow less bothersome and explain lower negative dysphotopsia rates using a 7.0 mm optic.
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Lentes Intraoculares , Iluminación , Humanos , Óptica y Fotónica , Retina , Campos VisualesRESUMEN
PURPOSE: To determine the current prevalence and trends of pseudophakia in a well-defined U.S. population, calculating values for Olmsted County, Minnesota, from 1988 through 2018. SETTING: Mayo Clinic, Rochester, Minnesota. DESIGN: Population-based cohort study. METHODS: Rochester Epidemiology Project (REP) databases were used to identify all cases of pseudophakia in Olmsted County, Minnesota, between January 1, 1988, and December 31, 2018. Age- and sex-specific prevalence rates were calculated in 1988, 1998, 2008, and 2018 using REP census population estimates and mortality counts. Poisson regression analysis was used to assess changes in prevalence over time. Mortality rates were estimated by Kaplan-Meier analysis. RESULTS: In 2018, 10 024 county residents were pseudophakic in at least 1 eye, for a total population prevalence of 6.5%. The prevalence increased 67% in the last 10 years and 590% in the last 30 years (P < .001). By 2018, 51% of residents aged 75 years and 88% of residents aged 85 years and older were pseudophakic in at least 1 eye, 53% of residents with pseudophakia aged 65 years and older were bilaterally pseudophakic, and 29% of residents with pseudophakia had lived with pseudophakia for more than 10 years. The prevalence was higher among women than men and increased with age (P < .001). Overall, pseudophakia had a lower all-cause mortality compared with the general Minnesota population (P < .001). CONCLUSIONS: In 2018, most residents aged 75 years and older were pseudophakic in at least 1 eye. These numbers underscore the changing visual status of older adults and the large number of adults who benefit from cataract surgery.
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Seudofaquia , Distribución por Edad , Anciano , Estudios de Cohortes , Femenino , Humanos , Incidencia , Masculino , Minnesota/epidemiología , Prevalencia , Seudofaquia/epidemiologíaRESUMEN
PURPOSE: To investigate the outcomes of cataract surgery in patients with active diabetic macular edema (DME) who are receiving active treatment with intravitreal anti-vascular endothelial growth factor (VEGF) injections in the perioperative period. DESIGN: Retrospective clinical cohort study. METHODS: We reviewed all patients who underwent cataract surgery and were receiving intravitreal anti-VEGF injections from January 1, 2012 through December 31, 2017. Thirty-seven eyes underwent cataract surgery and received ≥1 intravitreal anti-VEGF injection for a diagnosis of DME within 6 months before surgery. Outcome measures included the development of subretinal or intraretinal fluid in the 6 months after surgery, timing of injections, number of injections, best-corrected visual acuity, and central subfield thickness. RESULTS: There was a significant improvement between pre- and postoperative best-corrected visual acuity when comparing all eyes (Ps < .0001) and no significant difference in central subfield thickness before and after surgery (P > .05). There were 30 eyes (81.1%) that had fluid on the preoperative optical coherence tomography scan. Seventeen eyes (45.9%) developed new or worsening postoperative DME. Comparing the eyes that did or did not develop worsening DME, there were no differences in postoperative visual acuities (P > .05). Eyes that did develop new fluid had significant increases in postoperative central subfield thickness at both 1 month (350 vs 320 µm, P = .036) and 6 months (342 vs 305 µm, P = .013). CONCLUSION: In a real-world setting, patients with cataracts and actively treated DME may undergo cataract surgery but may see a worsening of DME not immediately affecting the best-corrected visual acuity.
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Catarata , Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Inhibidores de la Angiogénesis/uso terapéutico , Catarata/complicaciones , Catarata/tratamiento farmacológico , Estudios de Cohortes , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Estudios Retrospectivos , Tomografía de Coherencia ÓpticaRESUMEN
PURPOSE: The purpose of this study was to investigate the visual and anatomic outcomes in patients with macular edema due to retinal vein occlusions (RVO) who were actively managed with intravitreal anti-vascular endothelial growth factor (VEGF) before and after cataract surgery. METHODS: Retrospective, cohort study of all patients with RVO who underwent cataract surgery and were receiving intravitreal anti-VEGF injections from January 1st, 2012 through October 31st, 2018. There were 31 eyes that underwent cataract surgery and received at least one intravitreal anti-VEGF injection for a diagnosis of RVO within 6 months prior to surgery. Data collected included the development of subretinal or intraretinal macular fluid in the 6 months following surgery, timing of injections, number of injections, best corrected visual acuity (BCVA), and central subfield thickness (CST). RESULTS: There was a significant improvement between pre- and post-operative BCVA when comparing all eyes (p values < .0001) and no significant difference in CST before and after surgery (p > .05). Eyes without fluid pre-operatively saw an improvement in visual acuity, but with an initial significant increase in CST (p = .03) that normalized over time (p = .33) without an increase in frequency of anti-VEGF injections. CONCLUSION: Patients with cataracts who are actively managed for macular edema due to RVO with anti-VEGF agents may undergo cataract surgery, knowing they will have a transient increase in macular thickness that resolves without adjusting the frequency of intravitreal injections and is not visually significant.
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Inhibidores de la Angiogénesis/administración & dosificación , Extracción de Catarata , Catarata/complicaciones , Edema Macular/tratamiento farmacológico , Oclusión de la Vena Retiniana/complicaciones , Agudeza Visual , Anciano , Bevacizumab/administración & dosificación , Dexametasona/administración & dosificación , Femenino , Estudios de Seguimiento , Glucocorticoides/administración & dosificación , Humanos , Edema Macular/diagnóstico , Edema Macular/etiología , Masculino , Periodo Preoperatorio , Ranibizumab/administración & dosificación , Oclusión de la Vena Retiniana/diagnóstico , Oclusión de la Vena Retiniana/tratamiento farmacológico , Estudios Retrospectivos , Tomografía de Coherencia Óptica , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidoresRESUMEN
PURPOSE: To report normative angle alpha orientation and magnitude distribution in a cataract surgery patient population. SETTING: U.S. academic medical center. DESIGN: Retrospective review. METHODS: A total of 11 871 wavefront aberrometer/corneal topographer angle alpha measurements were performed over 40 months, yielding 8773 bilateral measurements (73.9%) with zero bad wavefront datapoints. The analysis was limited to the first right-eye scan for 3382 unique patients. The angle alpha magnitudes (millimeters) and orientations (degrees) were analyzed for these unique right eyes. RESULTS: For the 3,382 unique patients, the mean angle alpha magnitude was 0.44 ± 0.15 mm (median, 0.44 mm; 25th and 75th percentiles 0.34 mm, 0.53 mm). Angle alpha orientation was predominantly horizontal (P < .01), with a mean of 186 ± 32 degrees. The expected point of intraocular lens (IOL) centration (EPIC) based on the geometric center of the corneal limbus was temporal to the visual axis in 3212 eyes (95%), nasal in 92 eyes (2.7%), inferior in 56 eyes (1.7%), and superior in 22 eyes (0.6%). The mean angle alpha magnitude was 0.3 mm or less in 607 eyes (18%) and 0.5 mm or greater in 1089 eyes (32%). CONCLUSIONS: Angle alpha is a predominantly horizontal phenomenon with a mean EPIC of 0.44 mm temporal to the visual axis. This information may assist in determining eligibility for patients in multifocal IOL implantation.
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Segmento Anterior del Ojo/patología , Implantación de Lentes Intraoculares , Lentes Intraoculares Multifocales , Facoemulsificación , Aberrometría , Anciano , Anciano de 80 o más Años , Topografía de la Córnea , Femenino , Humanos , Masculino , Persona de Mediana Edad , Seudofaquia/patología , Estudios RetrospectivosAsunto(s)
Extracción de Catarata/efectos adversos , Subluxación del Cristalino/cirugía , Academias e Institutos/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cámara Anterior/patología , Cámara Anterior/cirugía , Femenino , Humanos , Subluxación del Cristalino/etiología , Masculino , Persona de Mediana Edad , Oftalmología/organización & administración , Sistema de Registros/estadística & datos numéricos , Reoperación , Estados Unidos , Agudeza Visual , Vitrectomía , Adulto JovenRESUMEN
BACKGROUND: Previous studies of postoperative corneal injury rates relied on provider-initiated incident reports, which may underestimate the true incidence. Postoperative administration of proparacaine eye drops is used almost exclusively to diagnose corneal injury; therefore, identifying instances of administration may provide a better estimate of corneal injuries. We compared proparacaine administration versus provider-initiated reports to determine rates of corneal injury. In addition, potential associations between clinical variables and injury were assessed with a matched case-control study. METHODS: The health records of 132,511 sequential adult postanesthesia recovery room admissions (January 1, 2011 to June 30, 2017) were reviewed to identify postoperative proparacaine administration and incident reports of corneal injury. Patients with corneal injury were matched with control patients at a 1:2 ratio to assess factors associated with injury. RESULTS: Proparacaine drops were administered to 442 patients (425 patients received proparacaine for diagnosis and 17 patients received proparacaine for unrelated reasons). Incident reports identified 320 injuries, and the aggregate corneal injury count was 436 (incidence, 3.3 injuries [95% confidence interval {CI}, 3.0-3.6] per 1000 cases of general anesthesia). Proparacaine administration had a greater case ascertainment percentage than incident reporting (97.5% vs 73.4%; P < .001). The matched case-control analysis found greater risks associated with longer duration of anesthesia (odds ratio, 1.05 [95% CI, 1.03-1.07] per 10 minutes of anesthesia; P < .001) and nonsupine surgical position (odds ratio, 3.89 [95% CI, 2.17-6.98]; P < .001). Patients with injuries also had more evidence of sedation and agitation during anesthesia recovery. CONCLUSIONS: Calculation of incidence by using the administration of a medication (proparacaine eye drops) that is almost exclusively used to diagnose a specific injury (corneal injury) showed higher case ascertainment percentage than incident-reporting methods. Similar strategies could be used to monitor the rates of other adverse events.
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Anestésicos Locales/administración & dosificación , Lesiones de la Cornea/diagnóstico , Lesiones de la Cornea/epidemiología , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/epidemiología , Propoxicaína/administración & dosificación , Anciano , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de RiesgoRESUMEN
Removing fish hooks is a common procedure performed by many emergency department providers. There are several techniques that are commonly employed to aid in successful removal. However, when a fish hook becomes embedded within the orbit, there are limited options as to avoid damaging vital surrounding structures. The authors report the removal of a fish hook within the anterior orbit using the string technique in a 25-year-old patient. The procedure was performed under general anesthesia with the aid of size 5 polyglactin suture wrapped around the hook. The procedure itself took less than 10 seconds and was successful in swiftly and safely removing the hook without damaging surrounding orbital structures. The patient recovered well without any permanent sequelae.
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Cuerpos Extraños en el Ojo/cirugía , Lesiones Oculares Penetrantes/cirugía , Órbita/cirugía , Suturas , Adulto , Humanos , Masculino , Microcirugia/métodosRESUMEN
PURPOSE: To investigate whether having macular fluid on optical coherence tomography (OCT) prior to cataract surgery adversely affected vision or anatomic outcomes after cataract surgery in patients with exudative age-related macular degeneration (AMD). DESIGN: Retrospective cohort study. METHODS: We examined all patients who underwent cataract surgery and were receiving intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections from January 1, 2012 through December 31, 2016. There were 81 eyes that underwent cataract surgery and had received at least 1 intravitreal anti-VEGF injection for a diagnosis of exudative AMD within 6 months prior to surgery. Data collected included the development of subretinal or intraretinal macular fluid, or subretinal hemorrhage, in the 6 months following surgery; number of injections; best-corrected visual acuity (BCVA); and central subfield thickness (CST). RESULTS: There was a significant improvement between preopertive and postoperative BCVA when comparing all patients (P values < .0001) and no significant difference in CST before and after surgery (P > .05). There were 23 eyes with fluid on the preoperative OCT. There were no differences in final BCVA or CST and no difference in the development of fluid postoperatively when compared to patients without fluid preoperatively (all P values > .05). These patients also saw a significant improvement in BCVA (P = .006). CONCLUSION: In a real-world setting, patients with both cataracts and wet AMD may safely undergo cataract surgery. Patients with stable preoperative fluid on OCT should be considered for cataract surgery, as these patients did well postoperatively, with no worsening of their neovascular process.
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Extracción de Catarata , Catarata/complicaciones , Líquido Subretiniano/diagnóstico por imagen , Degeneración Macular Húmeda/complicaciones , Anciano , Anciano de 80 o más Años , Inhibidores de la Angiogénesis/uso terapéutico , Exudados y Transudados/diagnóstico por imagen , Femenino , Humanos , Inyecciones Intravítreas , Implantación de Lentes Intraoculares , Masculino , Seudofaquia/fisiopatología , Estudios Retrospectivos , Tomografía de Coherencia Óptica/métodos , Resultado del Tratamiento , Agudeza Visual/fisiología , Degeneración Macular Húmeda/tratamiento farmacológico , Degeneración Macular Húmeda/fisiopatologíaRESUMEN
PURPOSE: To determine racial/ethnic differences in rates of complex cataract surgery among United States Medicare beneficiaries. SETTING: Departments of Ophthalmology and Health Science Research, Mayo Clinic, Rochester, Minnesota, USA. DESIGN: Retrospective case series. METHODS: The U.S. Medicare 5% Limited Data Set, representing a 5% sample of over 28 million fee-for-service Medicare beneficiaries predominantly aged 65 years and older, were analyzed for rates of complex cataract surgery (Current Procedural Terminology [CPT] code 66982) among all beneficiaries who had cataract surgery (CPT codes 66982, 66984), stratified by race/ethnicity between January 1, 2014, and December 31, 2014. Associations were tested by using multivariate regression analysis. RESULTS: Data from approximately 1 087 680 Medicare beneficiaries were analyzed. After adjustment for age and sex, the likelihood of complex cataract surgery was significantly higher in African Americans (odds ratio [OR], 1.90; 95% confidence interval [CI], 1.75-2.08), Asians (OR, 1.57; 95% CI, 1.34-1.85), and Hispanics (OR, 1.42; 95% CI, 1.18-1.71) than in whites among fee-for-service Medicare beneficiaries. Complex cataract surgery was more likely in men (OR, 1.83; 95% CI, 1.73-1.92) than in women, and the likelihood of complex cataract surgery increased in the elderly, with beneficiaries older than 84 years more likely to have complex surgery (OR, 2.68, 95% CI, 2.45-2.93) than beneficiaries aged 65 to 69 years. CONCLUSION: There were racial/ethnic differences in the likelihood of complex cataract surgery among fee-for-service Medicare beneficiaries; racial/ethnic minorities (Hispanics, Asians, and African Americans) were 42% to 90% more likely to have complex cataract surgery than whites.
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Extracción de Catarata/estadística & datos numéricos , Etnicidad/estadística & datos numéricos , Complicaciones Intraoperatorias/epidemiología , Medicare/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Grupos Raciales/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Estudios Transversales , Bases de Datos Factuales , Femenino , Humanos , Masculino , Análisis de Regresión , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
PURPOSE: To determine racial and ethnic differences in age-related macular degeneration (AMD) and the use of anti-vascular endothelial growth factor (VEGF) injections for AMD among United States Medicare beneficiaries. DESIGN: Cross-sectional Medicare database study. PARTICIPANTS: 2014 United States fee-for-service Medicare beneficiaries. METHODS: The 2014 Medicare 5% Limited Data Set Standard Analytic Files, representing a 5% sample of approximately 28 238 660 fee-for-service Medicare beneficiaries 65 years of age and older, were used to identify all beneficiaries who received a diagnosis of AMD and who received intravitreal anti-VEGF injections for AMD, stratified by race, gender, and age. Logistic regression analysis determined racial differences in the likelihood of an AMD diagnosis and anti-VEGF treatment for AMD, adjusted for age and gender. MAIN OUTCOME MEASURES: Number of beneficiaries diagnosed with AMD in 2014 and number of beneficiaries who received anti-VEGF intravitreal injections for AMD in 2014. RESULTS: Among approximately 28 238 660 Medicare beneficiaries in 2014, 2 210 000 (7.8%) were diagnosed with AMD. Among beneficiaries with an AMD diagnosis, 360 640 (16.3%) received 1 or more anti-VEGF intravitreal injection for AMD. After adjustment for age and gender, an AMD diagnosis was 74% less likely in African Americans (odds ratio [OR] 0.26; 95% confidence interval [CI], 0.25-0.27), 44% less likely in Latinos (OR, 0.56; 95% CI, 0.53-0.60), and 19% less likely in Asian Americans (OR, 0.81; 95% CI, 0.77-0.85) than in white beneficiaries. Anti-VEGF injections for AMD were 86% less likely in African Americans (OR, 0.14; 95% CI, 0.12-0.16), 61% less likely in Latinos (OR, 0.39; 95% CI, 0.33-0.45), and 48% less likely in Asian Americans (OR, 0.52; 95% CI, 0.46-0.60) than in whites. Race- and gender-adjusted odds of both AMD and the use of anti-VEGF agents for AMD increased with age (P < 0.001). CONCLUSIONS: There are racial differences in the prevalence of an AMD diagnosis and in receiving anti-VEGF injections for AMD among fee-for-service Medicare beneficiaries 65 years of age or older. African Americans, Latinos, and Asian Americans were 19% to 74% less likely to have a diagnosis of AMD and were 48% to 86% less likely to receive an anti-VEGF intravitreal injection for AMD than in whites.
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PURPOSE: To estimate geographic variations and surgeon and patient characteristics associated with the use of trabeculectomy and glaucoma drainage devices (GDDs) to treat glaucoma among US Medicare fee-for-service (FFS) beneficiaries. DESIGN: Observational cohort study of a Medicare claims database. PARTICIPANTS: US Medicare Part B FFS patients (age ≥65 years) and their glaucoma surgeons. METHODS: Analysis of Limited Data Set claims for the 5% sample from Medicare Provider and Utilization and Payment Data was used to identify trabeculectomy and GDD claims with diagnosis codes for patients treated in the United States from January 1, 2014, to September 30, 2015. The number of patients who underwent trabeculectomy or GDD placement was calculated for each US census region. Regional variations were evaluated with the extremal quotient. Multivariate binomial logistic regression was performed to analyze surgeon (career stage and sex), patient (age, race, sex, and ICD-9-CM diagnosis code), and regional characteristics associated with trabeculectomy and GDD placement. MAIN OUTCOME MEASURES: Rates of trabeculectomy and GDD placement performed for Medicare Part B FFS patients by US census region. RESULTS: From January 1, 2014, to September 30, 2015, the odds that patients received trabeculectomy versus GGD placement varied by region. Patients in the South (odds ratio [OR], 2.14; 95% confidence interval [CI], 1.74-2.66; P < 0.001) and Midwest (OR, 1.42; 95% CI, 1.11-1.83; P < 0.01) were significantly more likely to receive GDD placement than patients in the Northeast. The extremal quotient was 2.16, which confirmed high regional variation. Characteristics associated with increased odds of receiving GDD placement were age greater than 84 years (OR, 1.47; 95% CI, 1.11-1.95), African American race (OR, 1.37; 95% CI, 1.11-1.69), and ICD-9-CM diagnosis of glaucoma associated with vascular disorders (OR, 5.87; 95% CI, 2.78-12.41). CONCLUSIONS: High regional variation in trabeculectomy and GDD placement was observed. Placement of a GDD was more likely to be performed in the South. Placement of a GDD was more likely in African American patients and patients with glaucoma associated with vascular disorders, and was more likely performed by early-career surgeons.
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Implantes de Drenaje de Glaucoma/estadística & datos numéricos , Glaucoma/cirugía , Presión Intraocular/fisiología , Trabeculectomía/métodos , Agudeza Visual , Anciano , Estudios Transversales , Femenino , Estudios de Seguimiento , Glaucoma/epidemiología , Glaucoma/fisiopatología , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Estados Unidos/epidemiologíaRESUMEN
Purpose Endoxifen is a tamoxifen metabolite with potent antiestrogenic activity. Patients and Methods We performed a phase I study of oral Z-endoxifen to determine its toxicities, maximum tolerated dose (MTD), pharmacokinetics, and clinical activity. Eligibility included endocrine-refractory, estrogen receptor-positive metastatic breast cancer. An accelerated titration schedule was applied until moderate or dose-limiting toxicity occurred, followed by a 3+3 design and expansion at 40, 80, and 100 mg per day. Tumor DNA from serum (circulating cell free [cf); all patients] and biopsies [160 mg/day and expansion]) was sequenced. Results Of 41 enrolled patients, 38 were evaluable for MTD determination. Prior endocrine regimens during which progression occurred included aromatase inhibitor (n = 36), fulvestrant (n = 21), and tamoxifen (n = 15). Patients received endoxifen once daily at seven dose levels (20 to 160 mg). Dose escalation ceased at 160 mg per day given lack of MTD and endoxifen concentrations > 1,900 ng/mL. Endoxifen clearance was unaffected by CYP2D6 genotype. One patient (60 mg) had cycle 1 dose-limiting toxicity (pulmonary embolus). Overall clinical benefit rate (stable > 6 months [n = 7] or partial response by RECIST criteria [n = 3]) was 26.3% (95% CI, 13.4% to 43.1%) including prior tamoxifen progression (n = 3). cfDNA mutations were observed in 13 patients ( PIK3CA [n = 8], ESR1 [n = 5], TP53 [n = 4], and AKT [n = 1]) with shorter progression-free survival ( v those without cfDNA mutations; median, 61 v 132 days; log-rank P = .046). Clinical benefit was observed in those with ESR1 amplification (tumor; 80 mg/day) and ESR1 mutation (cfDNA; 160 mg/day). Comparing tumor biopsies and cfDNA, some mutations ( PIK3CA, TP53, and AKT) were undetected by cfDNA, whereas cfDNA mutations ( ESR1, TP53, and AKT) were undetected by biopsy. Conclusion In endocrine-refractory metastatic breast cancer, Z-endoxifen provides substantial drug exposure unaffected by CYP2D6 metabolism, acceptable toxicity, and promising antitumor activity.
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Neoplasias de la Mama/tratamiento farmacológico , Resistencia a Antineoplásicos/efectos de los fármacos , Tamoxifeno/análogos & derivados , Administración Oral , Adulto , Anciano , Anciano de 80 o más Años , Área Bajo la Curva , Inhibidores de la Aromatasa/uso terapéutico , Neoplasias de la Mama/genética , Neoplasias de la Mama/metabolismo , Fosfatidilinositol 3-Quinasa Clase I/genética , Citocromo P-450 CYP2D6/genética , Citocromo P-450 CYP2D6/metabolismo , ADN de Neoplasias/sangre , ADN de Neoplasias/genética , Supervivencia sin Enfermedad , Relación Dosis-Respuesta a Droga , Estradiol/análogos & derivados , Estradiol/uso terapéutico , Antagonistas de Estrógenos/efectos adversos , Antagonistas de Estrógenos/metabolismo , Antagonistas de Estrógenos/uso terapéutico , Femenino , Fulvestrant , Humanos , Persona de Mediana Edad , Mutación , Metástasis de la Neoplasia , Tamoxifeno/metabolismo , Tamoxifeno/farmacocinética , Tamoxifeno/uso terapéuticoRESUMEN
PURPOSE: To quantify Medicare beneficiary proximity to his or her yttrium-aluminum-garnet (YAG) laser capsulotomy-providing ophthalmologist and optometrist in Oklahoma by calculating driving distances and times. DESIGN: Cross-sectional cohort study using 2014 Oklahoma Medicare 100% and 5% data sets and Google Maps distance and travel time application programming interfaces. PARTICIPANTS: U.S. fee-for-service Medicare beneficiaries and Oklahoma ophthalmologist and optometrist laser capsulotomy providers. METHODS: The 2014 Medicare Provider Utilization and Payment Limited 100% and 5% datasets from the Centers for Medicare and Medicaid (CMS) were obtained to identify the office street addresses of Oklahoma ophthalmologists and optometrists who submitted claims to Medicare for a YAG laser capsulotomy, and the county addresses of the corresponding Medicare beneficiaries who received the laser capsulotomy. The shortest travel distances and travel times between the beneficiary and the laser provider were calculated by using Google Maps distance and travel time application programming interfaces. MAIN OUTCOME MEASURES: Beneficiary driving distances and times to his or her YAG laser capsulotomy-providing Oklahoma ophthalmologist and optometrist. RESULTS: In 2014, 90 (57%) of 157 Oklahoma ophthalmologists and 65 (13%) of 506 Oklahoma optometrists submitted a total of 7521 and 3751 YAG laser capsulotomy claims to Medicare, respectively. By using the Medicare Limited 5% dataset, there was no difference in driving distance between beneficiaries who received a laser capsulotomy from an ophthalmologist (median, 39 miles; interquartile range [IQR], 13-113 miles) compared with an optometrist (median, 46 miles; IQR, 13-125 miles; P = 0.93) or in driving time to an ophthalmologist (median, 47 minutes; IQR, 19-110 minutes) compared with an optometrist (median, 50 minutes; IQR, 17-117 minutes; P = 0.76). CONCLUSIONS: For Medicare beneficiaries, there was no difference in geographic access to YAG laser capsulotomy whether performed by an Oklahoma ophthalmologist or optometrist as determined by calculated driving distances and times.
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Conducción de Automóvil/estadística & datos numéricos , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Oftalmólogos/estadística & datos numéricos , Optometristas/estadística & datos numéricos , Capsulotomía Posterior , Pautas de la Práctica en Medicina/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Láseres de Estado Sólido/uso terapéutico , Masculino , Medicare Part B/estadística & datos numéricos , Oklahoma/epidemiología , Capsulotomía Posterior/estadística & datos numéricos , Factores de Tiempo , Viaje/estadística & datos numéricos , Estados UnidosRESUMEN
OBJECTIVE: To determine differences in the provision of Medicare services based on physician gender in the United States. PATIENTS AND METHODS: Participants included all 2013 Medicare fee-for-service physicians and their patients, a population that is predominantly older than 65 years. The 2013 Medicare Provider Utilization and Payment Data for services rendered between January 1, 2013, and December 31, 2013, were combined with the 2015 Physician Compare National Downloadable files and 2015 Berenson-Eggers Type of Service classification files. Total fee-for-service Medicare payments and Healthcare Common Procedure Coding System procedure codes for all fee-for-service beneficiaries were aggregated according to physician gender, specialty, years since medical school graduation, and type of service classifications. RESULTS: Excluding drug reimbursement, the mean total Medicare payments per female physician, compared with those for male physicians, were 41% in surgical specialties, 72% in hospital-based specialties, and 55% across all specialties (P<.001). The mean overall number of unique beneficiary visits per female physician was 59% of that for male physicians (P<.001). By using the Berenson-Eggers Type of Service classification, procedures and other services by female physicians were of 54% lower overall average intensity (allowed payments/number of unique patients) compared with those of male physicians. These differences persisted irrespective of years since medical school graduation (P<.001). CONCLUSION: Female physicians had smaller average total Medicare payments and fewer unique beneficiary visits than male physicians in the care of fee-for-service Medicare beneficiaries in 2013. The differences persisted across specialty types and years in practice. These data can identify variation but cannot determine causation or explain the reasons behind gender differences. These findings suggest, but do not prove, that female physician Medicare payments are lower due to different practice patterns, consisting of fewer patients cared for and lower intensity of care.
Asunto(s)
Planes de Aranceles por Servicios/economía , Reembolso de Seguro de Salud/economía , Médicos/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Humanos , Medicare , Factores Sexuales , Estados UnidosRESUMEN
PURPOSE: To test for associations between anti-vascular endothelial growth factor (VEGF) industry payments to ophthalmologists who provide intravitreal injections and specific anti-VEGF agent use. DESIGN: Cross-sectional Medicare database study. PARTICIPANTS: US fee-for-service Medicare beneficiaries and all ophthalmologists who submitted intravitreal injection claims for >10 Medicare beneficiaries between August 1, 2013, and December 31, 2013. METHODS: The Sunshine Act Open Payments database was searched for all industry financial relationships in ophthalmology. The Medicare Provider Utilization and Payment Database was searched for all intravitreal injection claims and anti-VEGF drug claims among fee-for-service Medicare beneficiaries. A novel algorithm was used to merge the 2 datasets to identify physician-specific associations between industry payments and specific anti-VEGF agent use. Odds ratios (ORs) and corresponding confidence intervals (CIs) were estimated by using logistic regression models. MAIN OUTCOME MEASURES: Ophthalmologists providing intravitreal injections (Current Procedural Terminology 67028); ophthalmologists with reported nonresearch payment from anti-VEGF industry; physician-specific anti-VEGF agent use (treatment specific J-codes J0178 and J2778). RESULTS: Of 3391 ophthalmologists who performed intravitreal injections, 1187 (35%) received nonresearch payments from anti-VEGF industry. Of these 1187 ophthalmologists, 422 (35%) received payments from Regeneron Pharmaceuticals, 363 (31%) received payments from Genentech, and 402 (34%) received payments from both industries. When compared with ophthalmologists who perform intravitreal injections and who do not receive anti-VEGF industry payments, ophthalmologists receiving Genentech payments (median, $90; interquartile range, $22-$149) were more likely to use ranibizumab (OR, 2.14; 95% CI, 2.12-2.16), those receiving Regeneron payments (median, $55; interquartile range, $22-$131) were more likely to use ranibizumab (OR, 1.55; 95% CI, 1.54-1.56) and aflibercept (OR, 1.23; 95% CI, 1.22-1.24), those with payments from both manufacturers were more likely to use ranibizumab (OR, 2.69; 95% CI, 2.67-2.71) and aflibercept (OR, 1.53; 95% CI, 1.52-1.54), and all were less likely to use bevacizumab (OR, 0.33-0.64; P < 0.001 for all comparisons). CONCLUSIONS: Industry payments to ophthalmologists who perform intravitreal injections were associated with higher odds of ranibizumab and aflibercept use, and lower odds of bevacizumab use. These findings reflect an association, not a cause-and-effect relationship.
RESUMEN
We present a case of successful removal of late calcium deposition on the posterior surface of a silicone intraocular lens (IOL) optic in association with asteroid hyalosis using a surgical technique that included pars plana vitrectomy, a lighted pick, and a modified silicone-tipped cannula. The lighted pick provided the most efficient and complete removal of calcium deposits. Postoperatively, the dystrophic calcification was removed and the IOL optic was clear at 6 months follow-up. The patient's symptoms resolved and uncorrected distance visual acuity returned to 20/20. This method can be considered in patients with dystrophic calcification of a silicone IOL in association with asteroid hyalosis and might avoid the need for IOL exchange and its associated complications and uncertain refractive outcomes.
Asunto(s)
Calcinosis , Lentes Intraoculares , Trastornos de la Visión , Vitrectomía , Humanos , Reoperación , Agudeza VisualRESUMEN
IMPORTANCE: Fuchs endothelial corneal dystrophy (FECD) is the most common indication for corneal transplant in the United States. The association between race/ethnicity and incidence of advanced FECD, defined by a need for endothelial or penetrating keratoplasty, has not been investigated. OBSERVATIONS: The 2014 US Medicare Limited Data Set (5% sample of 27â¯163â¯740 fee-for-service Medicare patients) was analyzed for rate of keratoplasty performed for FECD (International Classification of Diseases, Ninth Edition code 371.57), stratified by race/ethnicity. Among all Medicare beneficiaries 65 years or older, a diagnosis code for FECD was used in 1.55% (95% CI, 1.51%-1.59%) of white and 1.38% (95% CI, 1.26%-1.50%) of African American beneficiaries who had an ophthalmologist eye examination in 2014 (P = .01). Among beneficiaries who obtained medical care for FECD, keratoplasty was 1.9 times more likely in white than African American patients (4.7%; 95% CI, 4.2%-5.2% vs 2.5%; 95% CI, 1.1%-3.9%; P < .001) among approximately 6500 patients undergoing 8420 procedures. CONCLUSIONS AND RELEVANCE: In 2014, keratoplasty was 1.9 times more likely in US Medicare fee-for-service white patients than African American patients with FECD. This might be caused by racial/ethnic differences in the biology of FECD, access to care, or other unidentified factors.