Amblyopia Treatment Study
Atropine
+ Patch
Maladies du cerveau+12
+ Maladies du système nerveux central
+ Maladies des nerfs crâniens
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1999
Date à laquelle le premier participant a commencé l'étude.The Amblyopia Treatment Study (ATS) has been designed as a randomized, controlled single-masked multi-center clinical trial with the following objectives: To determine whether the success rate with atropine treatment of amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy. To develop more precise estimates of the success rates of amblyopia treatment. To identify factors that may be associated with successful treatment of amblyopia. To collect data on the clinical course of treated amblyopia to provide more precise estimates of treatment kinetics than now available.
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.20 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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
Age less than 7 years. Able to measure surrounded single optotype visual acuity using the ATS BVAT protocol. Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both. No more than 2 months of amblyopia therapy in the past 2 years. No current vision therapy or orthoptics. Visual acuity in the sound eye greater than or equal to 20/40. Visual acuity in the amblyopic eye less than or equal to 20/40 and greater than or equal to 20/100. Inter-eye acuity difference (IAD) greater than or equal to 3 LogMAR lines. No ocular cause for reduced visual acuity. Cycloplegic refraction and ocular examination within 2 months of enrollment. No myopia. Hyperopic/astigmatic refractive error, if present, corrected for at least 4 weeks. No prior intraocular surgery. Downs Syndrome not present. No known skin reactions to patch or bandage adhesives. No known allergy to atropine or other cycloplegics. Availability for at least 6 months of follow-up, has a home phone (or access to phone), and willing to be contacted by Jaeb Center staff.
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 1 site
National Eye Institute (NEI)
Bethesda, United StatesOuvrir National Eye Institute (NEI) dans Google Maps