Silicone Oil vs Gas Tamponade in Retinal Detachment Treatment
Collecte de données
Maladies oculaires+1
+ Maladies de la rétine
+ Décollement de la rétine
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 1985
Date à laquelle le premier participant a commencé l'étude.Retinal detachment complicated by PVR can be challenging to treat. While some cases respond well to pars plana vitrectomy and temporary support from intraocular gas, others may redetach. Preliminary findings suggest that prolonged support with liquid silicone can improve success rates, but there may be complications such as glaucoma and keratopathy. This study aims to compare the benefits of silicone oil versus gas as support methods in this procedure. It focuses on two groups: those who haven't had a prior vitrectomy (Group 1) and those who have (Group 2). The goal is to find a more effective and safer treatment approach for this condition. During the study, all participants undergo vitrectomy and are randomly assigned to receive either silicone oil or gas. The surgical procedure is standardized to relieve retinal traction, and the eye's response is assessed using an intraocular air support. The assignment to silicone oil or gas only happens after the surgical procedure to avoid any bias. Participants are then examined multiple times over a 36-month period, with repeat surgery allowed if necessary. The study's end points are visual acuity of 5/200 or greater and macular reattachment for 6 months following the final surgery. The success rates and complication rates of the two support methods are then compared.
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.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according to the Retina Society Classification and visual acuity of light perception or better.