RESUMO
OBJECTIVE: To describe fluorescein angiographic guidelines for the use of verteporfin therapy in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or other conditions based on 2-year vision outcomes from the Treatment of Age-Related Macular Degeneration With Photodynamic Therapy (TAP) Investigation and Verteporfin in Photodynamic Therapy (VIP) Trial. METHODS: Three multicenter, double-masked, placebo-controlled randomized clinical trials at 28 ophthalmology clinical centers in Europe and North America involving prospectively identified patients with best-corrected visual acuity (Snellen equivalent) of approximately 20/20 to 20/200, subfoveal CNV secondary to AMD or pathologic myopia with evidence of CNV, and a lesion greatest linear dimension of 5400 micro m or less. Fluorescein angiography was to be performed on all patients at enrollment and at regular 3-month follow-up visits through 2 years. The initial treatment laser spot size and all subsequent treatment decisions were based on the investigator's interpretation of these fluorescein angiograms. Photographic materials forwarded to the Wilmer Photograph Reading Center were reviewed by masked graders. MAIN OUTCOME MEASURES: Baseline angiographic features, including lesion composition and size, morphologic response to treatment during follow-up (eg, absence of leakage), and reliability (kappa values) of grading selected characteristics based on a 10% regrading of baseline visits. RESULTS: Terms and examples of different lesions and lesion components are provided to assist recognition of fluorescein angiographic characteristics of choroidal neovascular lesions that were important in determining when and where to apply verteporfin therapy. The kappa statistics for agreement of identification of lesion characteristics by the Wilmer Photograph Reading Center for these trials ranged from 0.70 to 0.85. CONCLUSIONS: Ophthalmologists should consider interpreting fluorescein angiographic images of subfoveal lesions with terms provided to follow recommendations regarding which patients are most likely to benefit from verteporfin therapy based on results from the TAP Investigation and VIP Trial.
Assuntos
Neovascularização de Coroide/diagnóstico , Neovascularização de Coroide/tratamento farmacológico , Angiofluoresceinografia/métodos , Fotoquimioterapia , Fármacos Fotossensibilizantes/uso terapêutico , Porfirinas/uso terapêutico , Neovascularização de Coroide/etiologia , Fóvea Central , Humanos , Degeneração Macular/complicações , Miopia/complicações , Fotografação , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Verteporfina , Acuidade VisualRESUMO
PURPOSE: To describe in detail occurrences of acute severe visual acuity decrease after photodynamic therapy (PDT) with verteporfin in the Treatment of Age-related macular degeneration with Photodynamic therapy (TAP) Investigation and the Verteporfin In Photodynamic therapy (VIP) Trial. DESIGN: Observational case series. METHODS: Retrospective review of all cases that developed acute severe visual acuity decrease after treatment. RESULTS: Of 15 acute severe visual acuity decrease events originally identified in 14 eyes of 14 patients, one event in one patient was judged unlikely to have been an acute severe visual acuity decrease event on retrospective review of these events in preparation of this report. Eleven events occurred after the first treatment. At follow-up, 10 improved by at least 1 line in visual acuity from the level noted at the time of the event. Of the nine patients returning for the month 24 examination, visual acuity decreased at least 3 lines from baseline in six, including at least 6 lines in four, and remained within 1 line in three. Associated abnormal morphology included three with a serous macular detachment and abnormal choroidal hypofluorescence, four with macular hemorrhage, three with a greenish subfoveal hemorrhage, and four with no abnormality. Events appeared to be more likely when patients had a visual acuity of 20/50 or better. CONCLUSIONS: Acute severe visual acuity decrease after PDT with verteporfin was an uncommon event; the risk did not outweigh the benefits of therapy previously reported. When considering verteporfin therapy, patients should be warned of the possibility of this serious adverse event.
Assuntos
Degeneração Macular/tratamento farmacológico , Fotoquimioterapia/efeitos adversos , Fármacos Fotossensibilizantes/efeitos adversos , Porfirinas/efeitos adversos , Transtornos da Visão/induzido quimicamente , Acuidade Visual/efeitos dos fármacos , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Doenças da Coroide/induzido quimicamente , Feminino , Angiofluoresceinografia , Fluorescência , Humanos , Masculino , Oftalmoscopia , Ensaios Clínicos Controlados Aleatórios como Assunto , Descolamento Retiniano/induzido quimicamente , Descolamento Retiniano/diagnóstico , Estudos Retrospectivos , Fatores de Risco , Verteporfina , Transtornos da Visão/diagnósticoRESUMO
Understanding and communicating the benefits vs. burdens of short daily home hemodialysis (SDHD) is presumed to be important to the success of recruiting patients and care partners and preventing dropout. We conducted an in-depth qualitative study of 13 patient and care partner couples (dyads) who completed at least 6 months of SDHD after at least 6 months of in-center hemodialysis to inform strategies for screening, training, and support to improve SDHD retention. In this exploratory descriptive study, all patients reported better well-being since starting SDHD. Considering the relationship and psychosocial factors, 4 profiles for dyadic coping emerged: (1) Thriving (n=5)--patients and care partners were flourishing; (2) Surviving (n=4)--strong couples were adjusting to challenges; (3) Martyrdom (n=3)--1 partner defers his/her needs and resentments to make SDHD work; and (4) Seeking another option (n=1)--patient unwilling to burden an anxious partner. Overall, patients who did more SDHD self-care, particularly self-cannulation, were more likely to thrive, regardless of dyad profile, and strong relationships tended to become stronger when faced with the challenge of SDHD. Training that was unhurried and valued care partners as well as patients, used a mix of learning strategies, and provided a home visit for the first home treatment was associated with Thriving dyads; training that was directive, inflexible, and focused on the patient at the expense of the partner was not. We recommend that centers screen dyads for relationship quality and integrate couple relationship education into SDHD training as required. Further, we recommend a large-scale, multi-center prospective study to test this model of how couple relationship and coping styles affect clinical outcomes and rates of continuation with SDHD.
Assuntos
Cuidadores/psicologia , Hemodiálise no Domicílio/psicologia , Autocuidado/psicologia , Adulto , Idoso , Coleta de Dados , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resolução de Problemas , Apoio SocialRESUMO
Se insertaron por asignación aleatoria 298 dispositivos intrauterinos (DIU), 148 del tipo TCu 380 A y 150 Nova T. Las quejas relacionadas con la inserción en ambos grupos fueron principalmente dolor pélvico y laceración cervical. Las usuarias de TCu 380 A presentaron una incidencia significativamente mayor de vaginitis (p< 0,05) que las usuarias de Nova T (x =4,02). La rata de embarazo accidental a los 12 meses fue de 1,4 por 100 mujeres entre las usuarias de TCu 380 A y de 3,3 por 100 mujeres entre las usuarias de Nova T (p<0,10). No hubo diferencia significativa entre los dos grupos para otros eventos tales como expulsión o retiro por razones personales. La tasa bruta de retiro según la tabla de vida de 12 meses por sangrado/dolor de TCu 380 A fue de 5,5 y la de Nova T 0,0 con significación estadística a (p<0,10) pero no a (p<0,05). El estudio indica que en la población venezolana estudiada ambos dispositivos se comportaron de manera similar