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1.
Clin Ophthalmol ; 16: 3213-3224, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36199805

RESUMO

Purpose: To evaluate the reproducibility of magnitude of postoperative IOL rotation following implantation of a toric intraocular lens (IOL) with modified haptics, in comparison with a Proof-of-Concept (POC) study of prototype IOLs featuring the same haptic design. Patients and Methods: A post-market, prospective, multicenter, single-arm, open-label clinical study was conducted. TECNIS Toric II IOL (Johnson & Johnson Vision, Irvine, CA, USA, Models ZCU150 to 600) were implanted in 125 subjects and evaluated at 1-day and 1-week postoperatively. An objective photographic method was used to determine postoperative IOL rotation. Uncorrected distance visual acuity (UCDVA), postoperative astigmatism, and surgeon satisfaction were also assessed. Rotation data were compared to the POC study in which two prototype non-toric monofocal IOLs, one with the same haptic design as Model ZCU, were studied. Results: Mean absolute rotation was 0.82° ± 1.0° and 0.84° ± 0.92°at 1-day and 1-week visits, respectively. The percentage of eyes with ≤5° of absolute rotation was 98.9% and 99.5% at the 1-day and 1-week visits, respectively. The magnitude of rotation was similar to the POC study prototype IOLs. At 1-week, mean monocular UCDVA was 0.026 ± 0.135 (~20/21) logMAR and mean residual manifest refractive cylinder was 0.30 D ± 0.35 D. The mean signed axis difference (postoperative minus operative) of the TECNIS Toric II IOL was 0.23° ± 1.27° at 1-day and -0.07° ± 1.25° at 1-week, indicating a clockwise drift. At 1-week, surgeons were very satisfied or satisfied with overall clinical outcomes and rotational stability in 98% of implanted eyes. Conclusion: The TECNIS Toric II IOL, with frosted, squared haptics, demonstrated low magnitude of postoperative IOL rotation, excellent uncorrected distance vision, and minimal residual astigmatism. The POC study design was supported, demonstrating that prototype non-toric monofocal IOLs can predict clinical performance of toric IOLs with the same haptic design.

2.
Clin Ophthalmol ; 16: 2441-2451, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35968054

RESUMO

Purpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability. Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5. Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥94% of cases regardless of cataract grade. Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.

3.
BMJ Case Rep ; 20172017 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-29070621

RESUMO

Anaplastic thyroid cancer is a rare form of thyroid cancer, known for its very poor prognosis, even with the appropriate management. It is very aggressive, with a tendency to invade locally and lymph node metastasis is often present at the time of diagnosis. We present an elderly patient, who presented with rapid enlarging neck mass, which, within weeks, led to his death. His family gave their consent to perform an autopsy, and here we describe and illustrate the profound aggressiveness of this tumour.


Assuntos
Carcinoma Anaplásico da Tireoide/patologia , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Neoplasias da Glândula Tireoide/patologia , Idoso , Autopsia , Evolução Fatal , Humanos , Masculino , Metástase Neoplásica/patologia , Estadiamento de Neoplasias , Prognóstico , Radiografia Torácica , Carcinoma Anaplásico da Tireoide/mortalidade
4.
J Cataract Refract Surg ; 43(5): 606-614, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28602320

RESUMO

PURPOSE: To evaluate precision pulse capsulotomy (PPC) in simple and challenging cataract surgery cases. SETTING: Clínica Quesada, San Salvador, El Salvador. DESIGN: Prospective case series. METHODS: This single-center prospective study assessed cataract surgeries with anterior capsulotomy performed using a PPC device through a 2.2 mm corneal incision in the presence of an ophthalmic viscosurgical device. This was followed by phacoemulsification and intraocular lens implantation. Outcomes included capsulotomy appearance and diameter, surgical complications, and postoperative visual acuity. RESULTS: The study comprised 38 eyes. All cases resulted in 360-degree complete, round capsulotomies averaging 5.5 mm in diameter with intracapsular IOL fixation. No PPC-related complications were observed intraoperatively or on follow-up at 3 to 8 months. The PPC was useful in challenging cases with corneal opacities that obscured the capsulotomy path or with poorly dilated pupils. Precision pulse capsulotomy occurs instantaneously everywhere along the capsulotomy path, which allowed safe release of subcapsular pressure in intumescent cataracts with consistent creation of a round, appropriately sized capsulotomy. The PPC edge quality was shown in a case with 6 clock hours of zonular dialysis in which iris hooks held the capsulotomy edge for over 45 minutes for removal of a 4+ cataract. CONCLUSIONS: Precision pulse capsulotomy had a short learning curve and was integrated seamlessly into the surgical routine. The combination of suction with ultrafast capsulotomy provided capsulotomy roundness, sizing, safety, and edge quality that significantly facilitated difficult cases. The ease of use, consistency, and efficiency of PPC capsulotomy might support its use under many practice scenarios.


Assuntos
Capsulorrexe , Extração de Catarata , Facoemulsificação , Capsulorrexe/métodos , Humanos , Facoemulsificação/métodos , Estudos Prospectivos , Acuidade Visual
5.
Acute Card Care ; 18(3): 65-69, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29172755

RESUMO

AIM: Cardiac myxomas are uncommon tumors and have a wide clinical spectrum. Their diagnosis can therefore be elusive because symptoms are nonspecific and misleading. Our aim was to characterize and analyze the clinical findings in patients presenting with cardiac myxomas. METHODS: We conducted a retrospective, hospital-based case study using the electronic records of a Spanish general hospital, caring for a population of 155,000. Patients' data were collected for the period between 2000 and 2016. Demographic data and clinical features were analyzed. RESULTS: Our series included 22 patients over a 15-year period (annual incidence of 0.94 patients per 100,000 inhabitants). Men were predominant (68%) and the median age was 69 years. Cardiac (40.9%), systemic (27.3%), and neurological manifestations (13.6%) were the main clinical features. Left atrium (81.8%) was the predominant location. Surgical treatment was performed in all patients and the overall outcome was good in all cases. CONCLUSIONS: Cardiac myxomas are uncommon, benign tumors, predominantly located in the left atrium and mainly affecting middle-aged and elderly male patients. Congestive heart failure, stroke, and systemic symptoms, although misleading and nonspecific, are the most frequent forms of clinical presentation.


Assuntos
Átrios do Coração/cirurgia , Insuficiência Cardíaca/cirurgia , Neoplasias Cardíacas/cirurgia , Mixoma/epidemiologia , Mixoma/cirurgia , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Insuficiência Cardíaca/diagnóstico , Neoplasias Cardíacas/diagnóstico , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Mixoma/diagnóstico , Estudos Retrospectivos , Caracteres Sexuais
8.
Rev. esp. geriatr. gerontol. (Ed. impr.) ; 45(6): 335-338, nov.-dic. 2010. tab, ilus
Artigo em Espanhol | IBECS | ID: ibc-82936

RESUMO

Introducción. La evolución natural de la estenosis aórtica severa sintomática no intervenida presenta un pronóstico infausto. Nos proponemos estudiar en este análisis las variables clínicas, ecográficas y analíticas que pudieran estar asociadas con el pronóstico vital en este subgrupo de pacientes. Material y métodos. Estudio retrospectivo de pacientes ingresados en nuestro centro entre 2004 y 2008 por síntomas asociados a la presencia de una estenosis aórtica severa y no considerados para intervención quirúrgica. Se analizaron datos demográficos, enfermedades concomitantes, datos ecocardiográficos (fracción de eyección, gradiente transvalvular, área valvular), analíticos (hemoglobina, creatinina, péptido natriurético auricular) y el cálculo del euroscore logístico Resultados. Fueron recogidos 49 pacientes (73,5% mujeres), con una edad media de 82,2±5,5 años. La mediana de seguimiento fue 396,0 días, rango intercualítico 99,5–731,0 días, con una mortalidad del 75,5%. En el análisis multivariante tan solo la medida de la fracción de eyección de ventrículo izquierdo por ecocardiografía fue un importante predictor en cuanto a la esperanza de vida (FE 35–50%: HR 3,74, IC 95% 1,11–12,65, p=0,034; FE<35%: HR 6,76, IC 95% 1,86–24,52, p=0,004). Conclusión. La esperanza de vida en pacientes con estenosis aórtica severa sintomática y no intervenidos se encuentra muy limitada, con una alta mortalidad durante el primer año. La fracción de eyección se asocia de forma significativa con el pronóstico en este tipo de pacientes(AU)


Introduction. The natural outcome of untreated severe symptomatic aortic stenosis in the elderly patient is extremely poor. In this analysis we studied the clinical, ultrasound and analytical variables, that could be associated with the vital prognosis in this patient sub-group. Material and methods. A retrospective study of patients admitted to our hospital between 2004 and 2008 due to symptoms associated with the presence of a severe aortic stenosis and were not considered for surgery. Demographic, concomitant diseases, ultrasound (ejection fraction, transvalvular gradient, valve area) and laboratory analytical data (haemoglobin, creatinine, atrial natriuretic peptide) were analysed and the logistic euroscore was calculated. Results. A total of 49 patients were included (73.5% women), with a mean age of 82.2±5.5 years. The median follow up was 396.0 days, interquartile range 99.5–731.0 days, with a mortality of 75.5%. In the multivariate analysis, only the left ventricular ejection fraction measured by ultrasound was an important predictor as regards life expectancy (EF 35–50%: HR 3.74, IC 95% CI; 1.11–12.65, P=0.034; EF<35%: HR 6.76, IC 95% CI; 1.86–24.52, p=0.004). Conclusion. The life expectancy of elderly patients with untreated severe symptomatic aortic stenosis is very limited, with a high mortality during the first year. The ejection fraction is significantly associated with the prognosis in these patients(AU)


Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico , Expectativa de Vida/tendências , Volume Sistólico , Volume Sistólico/fisiologia , Fatores de Risco , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Estudos Retrospectivos
9.
Rev Esp Geriatr Gerontol ; 45(6): 335-8, 2010.
Artigo em Espanhol | MEDLINE | ID: mdl-21075488

RESUMO

INTRODUCTION: The natural outcome of untreated severe symptomatic aortic stenosis in the elderly patient is extremely poor. In this analysis we studied the clinical, ultrasound and analytical variables, that could be associated with the vital prognosis in this patient sub-group. MATERIAL AND METHODS: A retrospective study of patients admitted to our hospital between 2004 and 2008 due to symptoms associated with the presence of a severe aortic stenosis and were not considered for surgery. Demographic, concomitant diseases, ultrasound (ejection fraction, transvalvular gradient, valve area) and laboratory analytical data (haemoglobin, creatinine, atrial natriuretic peptide) were analysed and the logistic euroscore was calculated. RESULTS: A total of 49 patients were included (73.5% women), with a mean age of 82.2±5.5 years. The median follow up was 396.0 days, interquartile range 99.5-731.0 days, with a mortality of 75.5%. In the multivariate analysis, only the left ventricular ejection fraction measured by ultrasound was an important predictor as regards life expectancy (EF 35-50%: HR 3.74, IC 95% CI; 1.11-12.65, P=0.034; EF<35%: HR 6.76, IC 95% CI; 1.86-24.52, p=0.004). CONCLUSION: The life expectancy of elderly patients with untreated severe symptomatic aortic stenosis is very limited, with a high mortality during the first year. The ejection fraction is significantly associated with the prognosis in these patients.


Assuntos
Estenose da Valva Aórtica , Admissão do Paciente , Recusa em Tratar , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Masculino , Estudos Retrospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
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