Argon Laser Photocoagulation and Aspirin Treatment for Diabetic Retinopathy Management
Colección de datos
Angiopatías Diabéticas+12
+ Retinopatía Diabética
+ Ceguera
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1979
Fecha en la que se inscribió al primer participante.The Early Treatment Diabetic Retinopathy Study (ETDRS) is a research study focused on evaluating the effectiveness of argon laser photocoagulation and aspirin treatment for managing diabetic retinopathy, a condition that affects the eyes of people with diabetes. This study is particularly interested in patients with nonproliferative or early proliferative diabetic retinopathy. The study involves a large group of 3,711 patients, who will be monitored for at least 4 years to gather comprehensive information on the benefits and risks of these treatments. In this study, one eye of each participant is randomly chosen for immediate photocoagulation, while the other eye is set to receive this treatment only when high-risk proliferative retinopathy develops. The study allows for additional photocoagulation during follow-ups if needed, but it's only required when the center of the macula is involved or threatened. The term 'clinically significant macular edema' is used to describe this level of severity. The study also includes aspirin therapy, based on previous observations of its potential benefits and its possible mechanisms of action. However, due to aspirin's known side effects, its use in this study is carefully controlled and monitored.
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 between the ages of 18 and 70 years with moderate or severe nonproliferative diabetic retinopathy or mild proliferative retinopathy in both eyes, with no previous photocoagulation treatment, and with visual acuity of 20/40 or better (20/200 or better if macular edema is present) were eligible for this study.