Comparison of Trabeculectomy and Argon Laser Trabeculoplasty Sequences in Advanced Glaucoma Management
Collecte de données
Maladies oculaires
+ Glaucome
+ Hypertension oculaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 1988
Date à laquelle le premier participant a commencé l'étude.The Advanced Glaucoma Intervention Study (AGIS) focuses on managing advanced glaucoma, a condition where medication alone can't lower eye pressure adequately, causing vision loss. Before 1980, a surgical procedure called trabeculectomy was commonly used. However, laser trabeculoplasty has gained popularity since then. The study aims to understand which sequence of these interventions yields the best long-term results, as success varies and some patients may need multiple procedures over time. The study involves individuals with advanced glaucoma, comparing two intervention sequences to manage the disease. Participants are randomly assigned to one of two sequences: either starting with trabeculectomy, followed by argon laser trabeculoplasty (ALT) if the first procedure fails, then a second trabeculectomy if ALT fails; or starting with ALT, followed by trabeculectomy if ALT fails, then another trabeculectomy if the first one fails. These interventions are supplemented with medication as needed. The study follows all patients for at least 5 years, scheduling regular examinations to evaluate visual function loss, intervention failure rates, complication rates, and the need for additional therapy. The primary outcome is the percentage of eyes with decreased vision, while secondary outcomes include sustained vision loss, intervention failures, number of prescribed glaucoma medications, and eye pressure levels.
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 35 à 80 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 35 and 80 with open-angle glaucoma that was not successfully controlled by medication were eligible for enrollment.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 13 sites
Yale University School of Medicine, Yale Eye Center
New Haven, United StatesOuvrir Yale University School of Medicine, Yale Eye Center dans Google MapsGeorgetown University, University Ophthalmic Consultants of Washington, Eye Associates of Washington, D.C.
Washington D.C., United StatesEmory University, Emory Eye Center
Atlanta, United StatesPiedmont Hospital, Eye Consultants of Atlanta
Atlanta, United States