RESUMEN
PURPOSE: The Zoster Eye Disease Study (ZEDS) is a multicenter randomized clinical trial (RCT) funded by the National Eye Institute aiming to determine the efficacy of suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) that enrolled fewer participants than planned (527/780, 67.6%). Understanding reasons for nonparticipation of likely eligible prescreened patients provides insights into patient populations that are not represented by ZEDS and barriers in clinical trials. METHODS: In this retrospective cohort study, HZO adults likely eligible for ZEDS with a history of a typical rash and a medical record within the past year of an episode of epithelial or stromal keratitis or iritis were prescreened at activated Participating Clinical Centers from 2017 to 2022 using a standard prescreening log. De-identified data including demographic information, reasons for exclusion because of ineligibility, and patient refusal were retrospectively entered into REDCap and analyzed. RESULTS: Prescreening logs with reasons for nonconsent (1244/1706, 72.9%) were included in the data set. Patients were excluded from the study (915/1244, 73.6%) because they did not meet all inclusion criteria (619/915, 67.7%) or met an exclusion criterion (296/915, 32.3%). Among the 12 exclusion criteria for the ZEDS study, immunocompromise (76/296, 25.7%) and renal insufficiency (50/296, 16.9%) were most frequently reported. Patient refusal to participate (327/1,244, 26.3%) was common. CONCLUSION: The most common reasons for ineligibility were immunocompromise and renal insufficiency. There may be benefits to long-term antiviral use in these populations not captured in ZEDS. A quarter (26.3%) of prescreened patients refused participation, showing the substantial impact of patient preferences on trial participation.
Asunto(s)
Antivirales , Herpes Zóster Oftálmico , Humanos , Estudios Retrospectivos , Masculino , Herpes Zóster Oftálmico/tratamiento farmacológico , Femenino , Persona de Mediana Edad , Anciano , Antivirales/uso terapéutico , Adulto , Valaciclovir/uso terapéutico , Selección de PacienteRESUMEN
PURPOSE: The Zoster Eye Disease Study (ZEDS) is the first randomized clinical trial to study the efficacy of long-term (1 year) suppressive valacyclovir treatment on herpes zoster ophthalmicus (HZO) outcomes. This article details the baseline characteristics of participants. SETTING: The study was set at 95 participating clinical centers in 33 states, Canada, and New Zealand. STUDY POPULATION: Immunocompetent adults with a history of a characteristic HZO unilateral rash and documentation of an episode of active dendriform epithelial keratitis, stromal keratitis, endothelial keratitis, or iritis within the preceding year, enrolled in ZEDS from November 2017 to January 2023. INTERVENTION: Participants were randomized to double-masked oral valacyclovir 1 gm daily versus placebo for 1 year of treatment and followed for 18 months. RESULTS: Five hundred twenty-seven participants were enrolled across 4 strata according to age at HZO onset (younger or older than 60 years) and duration of HZO at enrollment (less or greater than 6 months), with an even distribution of men and women and a median age of 60 years. More participants with recent (57%, 300/527) than chronic HZO and younger than 60 years at HZO onset (54%, 286/527) were enrolled. Most participants were treated acutely with a recommended antiviral regimen (91%, 480/527) and had not been vaccinated against zoster (79%, 418/527). CONCLUSIONS: The broad ZEDS study population enhances the likelihood that ZEDS will provide generalizable high-quality evidence regarding the efficacy and safety of suppressive valacyclovir for HZO immunocompetent adults and whether it should become standard of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03134196.
RESUMEN
Relatar um caso de depósito corneano de cobre em ambos os olhos a nível da membrana de Descemet associado a gamopatia monoclonal de significância indeterminada (GMSI). Paciente feminina, 49 anos, leucodérmica, apresentando depósito corneano de aspecto marrom-ouro a nível da membrana de Descemet em ambos os olhos. Exame sistêmico revelou cobre sérico elevado, ceruloplasmina sérica normal, e proteína total normal. Eletroforese de proteínas séricas demonstrou um pico único na região gama (proteína M = 11 g/l). Análise citométrica de aspirado medular evidenciou uma população de células plasmáticas monoclonais de aproximadamente 2% do total de células medulares consistente com o diagnóstico de gamopatia monoclonal de significância indeterminada. Depósitos de cobre a nível da membrana de Descemet podem ser encontrados em pacientes com gamopatia monoclonal de significância indeterminada.
Asunto(s)
Humanos , Femenino , Persona de Mediana Edad , Cobre/análisis , Gammopatía Monoclonal de Relevancia Indeterminada/diagnóstico , Lámina Limitante Posterior/química , Paraproteinemias/diagnóstico , Electroforesis de las Proteínas Sanguíneas , Cobre/sangre , Gammopatía Monoclonal de Relevancia Indeterminada/sangre , Lámina Limitante Posterior/metabolismo , Paraproteinemias/sangreRESUMEN
Objetivo: Apresentar e analisar os resultados cirúrgicos de ceratoplastias penetrantes realizadas em olhos apresentando seqüelas corneanas devido à infecção prévia pelo vírus varicela-zoster. Local: Serviço de Córnea, Doenças Externas Oculares e Cirurgia Refrativa do Wills Eye Hospital (Philadelphia, USA). Métodos: Estudo retrospectivo no qual foram analisadas as informações contidas nos prontuários dos pacientes submetidos à ceratoplastia penetrante entre janeiro de 1989 e dezembro de 1998, devido a seqüelas corneanas relacionadas à infecção prévia pelo vírus varicela-zoster, no Serviço de Córnea do Wills Eye Hospital, Philadelphia (PA). Resultados: Quinze pacientes (15 olhos) foram transplantados no intervalo de tempo pesquisado, 12 deles apresentavam ceratopatia causada por episódio prévio de herpes zoster ocular e três devido à varicela. Doze pacientes eram do sexo feminino e apenas três do sexo masculino. A idade média encontrada foi de 57 anos (4-83 anos). Em quatro olhos realizou-se tarsorrafia lateral associada à ceratoplastia penetrante. Três olhos apresentaram quadro de rejeição do tipo endotelial no pós-operatório e foram tratados com êxito através do uso tópico de soluções de prednisolona. Um dos pacientes evoluiu com falência primária do enxerto após a primeira cirurgia, sendo reoperado e, novamente, apresentou falência primária do enxerto devido à ceratopatia neurotrófica. Outros três casos submetidos a um segundo transplante após falência do primeiro enxerto apresentavam enxertos transparentes na última avaliação realizada. Após um período médio de acompanhamento pós-operatório de 50 meses, 13 enxertos (86,7 por cento) encontravam-se transparentes e em oito olhos (53,3 por cento) a acuidade visual corrigida era igual ou superior a 20/100. Cinco olhos apresentavam enxerto transparente e acuidade visual final inferior a 20/100 devido a alterações no segmento posterior ocular. Conclusão: Resultados cirúrgicos favoráveis podem ser obtidos em transplantesde córnea realizados em olhos apresentando ceratopatia relacionada à infecção prévia pelo vírus varicela-zoster. Para isso são fundamentais um cuidadoso acompanhamento pós-operatório e a proteção constante da superfície ocular através de lubrificação freqüente e, se necessário, tarsorrafia lateral
Asunto(s)
Humanos , Masculino , Femenino , Preescolar , Niño , Adolescente , Adulto , Persona de Mediana Edad , Herpes Zóster Oftálmico , Queratoplastia Penetrante , Anciano de 80 o más Años , Varicela , Evaluación de Procesos y Resultados en Atención de SaludRESUMEN
A retrospective study of 246 consecutive patients fit with daily and extended wear soft contact lenses was undertalken to determine the incidence and range of lens related problems is cosmetic, aphakic, and keratoplasty patients in a cornea service setting. Adequate data for inclusion in the study were available from 212 patients, who were folloowed for a minimum of six months (range 6-42 months; memdian 30 months). Approximately half (105 of 212; 50%) of the patients demonstrated problems. The most common problem was corneal neovascularization (61 of 212; 29%), which was greater than 1mm in 10% (22 of 212). Seious complications were infrequent. Two aphakic graft patients developed suture abscesses and three had rejection episodes. Overall, extended wear lens patients were significantly more likely to have complications (62 of 85; 73%) thandaily wear lens patients (43 of 127; 34%) (P < 001). Cosmetic lens patients were significantly less likely to have problems (34 of 98; 35%) than aphakic patients (35 of 50; 70%) (P , 001). Our data suggest that problems (including peripheral neovascularization, deposits, and chemical reactions related to soft lens wear) are common, but serious, visiontion, deposits, and chemical reactions related do soft lens wear) are common, but serious, visionthreatening complications (including corneal ulcers) are infrequent when lenses are fit carefully and patients are repeatedly instructed regarding lens use