Comparison of Trabeculectomy and Argon Laser Trabeculoplasty Sequences in Advanced Glaucoma Management
Colección de datos
Enfermedades Oculares
+ Glaucoma
+ Hipertensión Ocular
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1988
Fecha en la que se inscribió al primer participante.The Advanced Glaucoma Intervention Study (AGIS) focuses on managing advanced glaucoma, a condition where medication alone can't lower eye pressure adequately, causing vision loss. Before 1980, a surgical procedure called trabeculectomy was commonly used. However, laser trabeculoplasty has gained popularity since then. The study aims to understand which sequence of these interventions yields the best long-term results, as success varies and some patients may need multiple procedures over time. The study involves individuals with advanced glaucoma, comparing two intervention sequences to manage the disease. Participants are randomly assigned to one of two sequences: either starting with trabeculectomy, followed by argon laser trabeculoplasty (ALT) if the first procedure fails, then a second trabeculectomy if ALT fails; or starting with ALT, followed by trabeculectomy if ALT fails, then another trabeculectomy if the first one fails. These interventions are supplemented with medication as needed. The study follows all patients for at least 5 years, scheduling regular examinations to evaluate visual function loss, intervention failure rates, complication rates, and the need for additional therapy. The primary outcome is the percentage of eyes with decreased vision, while secondary outcomes include sustained vision loss, intervention failures, number of prescribed glaucoma medications, and eye pressure levels.
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 35 a 80 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
Men and women between the ages of 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.
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 13 ubicaciones
Yale University School of Medicine, Yale Eye Center
New Haven, United StatesAbrir Yale University School of Medicine, Yale Eye Center en Google MapsGeorgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., United StatesEmory University, Emory Eye Center
Atlanta, United StatesPiedmont Hospital, Eye Consultants of Atlanta
Atlanta, United States