Intravenous Methylprednisolone and Oral Prednisone for Optic Neuritis
Collecte de données
Maladies Auto-immunes+8
+ Maladies des nerfs crâniens
+ Maladies démyélinisantes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1988
Date à laquelle le premier participant a commencé l'étude.Optic neuritis, a condition affecting the optic nerve, often impacts young adults and is more common in women. It's the second most prevalent acquired optic nerve disorder in people under 50. While visual recovery is typically good, it's seldom complete, and patients usually show signs of optic nerve damage afterwards. Before the Optic Neuritis Treatment Trial (ONTT), there were no established guidelines for treating this condition. The ONTT is important because it aims to find effective treatments and understand the link between optic neuritis and multiple sclerosis, as optic neuritis can be the first sign of MS or occur later in its course. In this study, participants are randomly assigned to one of three treatment groups at 15 clinical centers in the US. The groups receive either oral prednisone for 14 days, intravenous methylprednisolone for 3 days followed by oral prednisone for 11 days, or a placebo for 14 days. Each treatment is followed by a short oral taper. The study measures visual recovery and long-term visual outcomes through tests of visual acuity, contrast sensitivity, color vision, and visual field at baseline, seven follow-up visits in the first 6 months, and then yearly. A standardized neurological examination is also conducted at baseline, after 6 months, and then annually.
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 46 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
The major eligibility criteria for enrollment into the ONTT included the following: Age range of 18 to 46 years Acute unilateral optic neuritis with visual symptoms for 8 days or less A relative afferent pupillary defect and a visual field defect in the affected eye No previous episodes of optic neuritis in the affected eye No previous corticosteroid treatment for optic neuritis or multiple sclerosis No systemic disease other than multiple sclerosis that might be the cause of the optic neuritis
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 15 sites
California Pacific Medical Center
San Francisco, United StatesGeorgetown University
Washington D.C., United StatesUniversity of Florida
Gainesville, United States