Amblyopia Treatment Study
Atropine
+ Patch
Enfermedades del Cerebro+12
+ Enfermedades del Sistema Nervioso Central
+ Enfermedades del Nervio Craneal
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 1999
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 20 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
National Eye Institute (NEI)
Bethesda, United StatesAbrir National Eye Institute (NEI) en Google Maps