Ocular Motor Development During the First Seven Months of Life in Infants With and Without a Family History of Strabismus
Collecte de données
Maladies des nerfs crâniens+2
+ Maladies oculaires
+ Maladies du système nerveux
Résumé
Date de début de l'étude : 1 octobre 1999
Date à laquelle le premier participant a commencé l'étude.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.
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.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 autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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.
Centres d'étude
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National Eye Institute (NEI)
Bethesda, United StatesOuvrir National Eye Institute (NEI) dans Google Maps