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Development of the Eye Motor System During the First 7 Months of Life in Infants With and Without a Family History of Cross-Eye

This study has been completed.
Study NCT00001143.   Last updated on March 3, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Development of the Eye Motor System During the First 7 Months of Life in Infants With and Without a Family History of Cross-Eye
Official Title  Ocular Motor Development During the First Seven Months of Life in Infants With and Without a Family History of Strabismus
Brief Summary

Little is known about the development of the ocular, or eye, motor system (the parts of the brain that control how the eyes move) in children. Recent technological and methodological advances now enable researchers to investigate the visual system and ocular motor system of infants, but few findings have been reported. This study hypothesizes that quantitative analysis of "at-risk" infants' eye movement systems can detect abnormalities that precede and predict the onset of strabismus, or cross-eye.

We will collect data on the eye movements of a group of infants born between 36 and 44 weeks after conception. These infants will be enrolled between 4 and 24 weeks after birth and followed at 4-week (+/- 5 days) intervals until 28 weeks of age and then once a year until 3 years after birth. The infants will undergo a complete ophthalmic evaluation at each visit after they enroll. At all visits up to 28 weeks of age, they will also undergo analysis of eye movements. We also will monitor the development of ocular alignment and check to detect other visual system abnormalities. The study will provide basic knowledge about the cause of both normal and abnormal alignment of both eyes in infants in the first 28 weeks of life.

Detailed Description

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.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Healthy
Strabismus
Intervention 
MEDLINE PMIDs 3057727,   8776457,   8594826
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  20
Start Date  October 1999
Completion Date October 2002
Eligibility Criteria 

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.

Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001143
Organization ID 000005
Secondary IDs †† 00-EI-0005
Study Sponsor  National Eye Institute (NEI)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date October 2002
First Received Date  November 3, 1999
Last Updated Date March 3, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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