Optic Neuritis Treatment and Long-Term Follow-Up Study
Colección de datos
Enfermedades Desmielinizantes+6
+ Enfermedades del Nervio Craneal
+ Enfermedades Autoinmunes
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1988
Fecha en la que se inscribió al primer participante.Optic neuritis is a condition that affects young adults, especially women, causing inflammation in the optic nerve. It's the second most common acquired optic nerve disorder in people under 50. While visual recovery is generally good, it's rarely complete, and most patients continue to show signs of optic nerve damage. Before the Optic Neuritis Treatment Trial (ONTT), there were no established guidelines for treating optic neuritis. This study, known as the Longitudinal Optic Neuritis Study (LONS), aims to provide a clearer understanding of the condition and its treatment, potentially improving care for those affected. In this study, participants are assigned to one of three treatment groups at 15 clinical centers in the United States. The groups receive either oral prednisone for 14 days, intravenous methylprednisolone for 3 days followed by oral prednisone for 11 days, or a placebo for 14 days. The recovery and long-term visual outcomes are evaluated through measures of visual acuity, contrast sensitivity, color vision, and visual field at baseline, at seven follow-up visits in the first 6 months, and then yearly. A standardized neurological examination is also conducted at baseline, after 6 months, and then annually.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 46 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
The major eligibility criteria for enrollment into the ONTT included the following: Age range of 18 to 46 years Acute unilateral optic neuritis with visual symptoms for 8 days or less A relative afferent pupillary defect and a visual field defect in the affected eye No previous episodes of optic neuritis in the affected eye No previous corticosteroid treatment for optic neuritis or multiple sclerosis No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 15 ubicaciones
California Pacific Medical Center
San Francisco, United StatesGeorgetown University
Washington D.C., United StatesUniversity of Florida
Gainesville, United States