- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001143
Development of the Eye Motor System During the First 7 Months of Life in Infants With and Without a Family History of Cross-Eye
Ocular Motor Development During the First Seven Months of Life in Infants With and Without a Family History of Strabismus
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Eye Institute (NEI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Shupert C, Fuchs AF. Development of conjugate human eye movements. Vision Res. 1988;28(5):585-96. doi: 10.1016/0042-6989(88)90108-3.
- Norcia AM. Abnormal motion processing and binocularity: infantile esotropia as a model system for effects of early interruptions of binocularity. Eye (Lond). 1996;10 ( Pt 2):259-65. doi: 10.1038/eye.1996.55.
- Dobkins KR, Teller DY. Infant contrast detectors are selective for direction of motion. Vision Res. 1996 Jan;36(2):281-94. doi: 10.1016/0042-6989(95)00094-g.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 000005
- 00-EI-0005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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