Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001143
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
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
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Ocular Motor Development During the First Seven Months of Life in Infants With and Without a Family History of Strabismus
Status:
COMPLETED
Status Verified Date:
2002-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-EI-0005 | None | None | None |