Ocular Motor Development During the First Seven Months of Life in Infants With and Without a Family History of Strabismus
Colección de datos
Enfermedades del Nervio Craneal+2
+ Enfermedades Oculares
+ Enfermedades del sistema nervioso
Resumen
Fecha de inicio: 1 de octubre de 1999
Fecha en la que se inscribió al primer participante.Little is known about the development of the ocular motor system in children. We hypothesize that quantitative analysis of "at risk" infants eye movement systems can detect abnormalities that precede and predict the onset of strabismus. We will collect data on the eye movements of a group of infants born between 36 and 44 weeks of post-conceptual age. These infants are enrolled between 4 and 24 weeks after birth and followed at 4 week (+/-5 days) intervals until 28 weeks of age and then yearly until 3 years after birth. After study enrollment infants will undergo a complete ophthalmic evaluation and ocular motor analysis at all study visits. The ocular motor analysis will include evaluation of ocular following, saccadic, pursuit and vergence eye movements using stimulus paradigms that have been specially developed for use in children. Children will be followed on an annual basis after 28 weeks of age until age 3 years to monitor the development of ocular alignment and to detect other visual system abnormalities. Study endpoints for each subject are at 28 weeks of age (ocular motor recordings completed) and 3 years of age (ophthalmic examinations completed). This will provide basic knowledge regarding the etiology of both normal and abnormal binocular alignment in infants in the first 28 weeks of life.
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.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 permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Participants must have a gestational age at birth between 36-42 weeks and birth weight greater than or equal to 2500 gms. Participants must have normal growth and development as assessed by general pediatric examination and growth charts, obtained historically from family and/or pediatrician. Participants must have a normal visual system by ophthalmic examination. Participants must be between the post-conceptual ages of 40 weeks and 70 weeks of age inclusive. Participants must be able to undergo a complete opthalmic evaluation. Participants must be able to undergo standard eye movement recording. Participants must not have any eye diseases. Participants must not have any neurologic disease, developmental delay, congenital genetic syndromes, congenital organ malformations, malformation syndromes or metabolic diseases. Participants must not be on any systemic or ocular medications.
Centros del Estudio
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National Eye Institute (NEI)
Bethesda, United StatesAbrir National Eye Institute (NEI) en Google Maps