Early Vitrectomy vs. Conventional Management in Severe Diabetic Retinopathy
Collecte de données
Maladies Cardiovasculaires+12
+ Diabète Mellitus
+ Angiopathies diabétiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1976
Date à laquelle le premier participant a commencé l'étude.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.
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 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.