Central Vein Occlusion Study (CVOS)
Colección de datos
Enfermedades Cardiovasculares+3
+ Enfermedades Oculares
+ Enfermedades de la Retina
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 1988
Fecha en la que se inscribió al primer participante.Central vein occlusion is a common retinal vascular disorder with potentially blinding complications. The two major complications are reduced central vision caused by macular edema and neovascular glaucoma caused by iris neovascularization. Other clinical trials have shown that laser photocoagulation is an effective treatment for complications found in diabetic retinopathy and branch vein occlusion, which have some features in common with CVO: neovascularization and reduced visual acuity caused by macular edema occur in all three disorders. Evidence from small-scale studies suggests that a grid pattern of photocoagulation reduces macular edema in CVO patients, although the associated changes in visual acuity are variable. The CVOS is a detailed investigation of grid pattern photocoagulation in a larger randomized group of patients. Eligible patients were divided into four groups: Group N: Eyes with extensive retinal ischemia (at least 10 disc areas of nonperfusion) were randomly assigned to receive panretinal photocoagulation or nontreatment unless iris neovascularization developed. Group M: Eyes with visual loss ascribable to macular edema were randomly assigned to receive grid-pattern photocoagulation or nontreatment. Group P: Eyes with relatively perfused retinas were followed to provide information about the natural history of the disease. Group I: Indeterminate eyes in which the retina could not be visualized accurately because of hemorrhage were followed in a natural history study. Green argon laser with a slit lamp delivery system was used for all treatments. Photographic documentation of retinal changes was obtained at entry, post-treatment, and at specified followup visits for a period of at least 3 years. The frequency of followup visits varied according to the group to which the CVO patient was assigned. Visual acuity, the primary outcome factor in the group with macular edema, was measured according to a modified Early Treatment Diabetic Retinopathy Study protocol at each visit.
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.A partir de 21 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 must have been age 21 or older and willing to return for followup visits for 3 years following assignment into the appropriate group and randomization. Each of the four groups has specific eligibility criteria. Patients with retinal vascular disease other than that specified in the criteria, such as diabetic retinopathy, were ineligible. Patients with macular disease other than that due to CVO were ineligible for that portion of the study.