Argon Laser Photocoagulation and Aspirin Treatment for Diabetic Retinopathy Management
Collecte de données
Cécité+13
+ Maladies Cardiovasculaires
+ Diabète Mellitus
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1979
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 70 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.