Early Vitrectomy vs. Conventional Management in Severe Diabetic Retinopathy
Colección de datos
Angiopatías Diabéticas+11
+ Retinopatía Diabética
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de octubre de 1976
Fecha en la que se inscribió al primer participante.This study is about exploring the benefits and risks of a procedure called vitrectomy for people with diabetic retinopathy, a condition that affects the eyes. Diabetic retinopathy can cause bleeding in the eye and lead to vision loss. The study aims to find out if performing vitrectomy early can improve vision or if it might lead to more serious complications than the usual care. The study is important because it could help doctors understand the best way to treat this condition and potentially improve care for people with diabetic retinopathy. The study involves two parts. In the first part, people who have severe vision loss due to bleeding in the eye are randomly assigned to either get an early vitrectomy or follow the usual care. If the bleeding doesn't clear up after a year or if the retina starts to detach, then a vitrectomy is performed. In the second part, people with severe fibrovascular proliferations but still have useful vision are also randomly assigned to either get an early vitrectomy or follow the usual care. The usual care includes a treatment called photocoagulation, and a vitrectomy is performed if there's severe bleeding that doesn't clear up within 6 months or if the retina starts to detach. All participants are checked every 6 months for 2 years and then once a year to see how their vision changes.
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 70 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 eligible for the vitreous hemorrhage group had at least one eye with recent severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients eligible for the "very severe proliferative retinopathy with useful vision" group had extensive active fibrovascular proliferations and visual acuity of 10/200 or better.