NCT00001143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 1999

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2002

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Eye MovementsStrabismusInfantsDevelopmentOcular Motor System

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 3057727BACKGROUND
  • 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.

    PMID: 8776457BACKGROUND
  • 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.

    PMID: 8594826BACKGROUND

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

October 1, 1999

Study Completion

October 1, 2002

Last Updated

March 4, 2008

Record last verified: 2002-10

Locations