Status:
COMPLETED
An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Infantile Esotropia
Acquired Non-accommodative Esotropia
Eligibility:
All Genders
Up to 4 years
Brief Summary
The purpose of this study is to: * To estimate the duration of misalignment by age at presentation in infantile esotropia (infantile ET), acquired non-accommodative esotropia (ANAET) and acquired par...
Detailed Description
Approximately one third of infants with infantile esotropia (infantile ET) and a similar proportion of children with acquired non-accommodative esotropia (ANAET) will have an increasing angle within t...
Eligibility Criteria
Inclusion
- For infantile ET:
- Less than 12 months old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- A constant or variable esotropia
- Onset before six months of age
- Measuring \>10 PD by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation on an accommodative target
- Gestational age \> 34 weeks
- Birth weight \> 1500 grams
- For ANAET:
- 6 months to \<5 years old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- A constant or variable esotropia
- Onset after six months of age
- Angle decreases less than 10 prism diopters (PD) by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
- Residual angle measures \>10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
- For patients who have significant refractive error, full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks.
- For patients who do not have significant refractive error, whether to prescribe spectacles is at investigator discretion, however, if the investigator elects to prescribe spectacles, the full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks
- Gestational age \> 34 weeks
- Birth weight \> 1500 grams
- For APAET:
- Onset after six months of age
- 6 months to \<5 years old
- Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
- Angle decreases 10 prism diopters (PD) or more by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
- A constant or variable esotropia
- Residual angle measures \>10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
- For patients who have significant refractive error, full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks.
- For patients who do not have significant refractive error, whether to prescribe spectacles is at investigator discretion, however, if the investigator elects to prescribe spectacles, the full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks
- Gestational age \> 34 weeks
- Birth weight \> 1500 grams
Exclusion
- For infantile ET:
- prior spectacle wear
- For infantile ET,ANAET,APAET:
- Atropine use within the last two weeks
- History of CNS disease (e.g. intraventricular hemorrhage (IVH), PVL, meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)
- Significant developmental delay in the investigator's judgment (isolated speech delay excepted)
- Limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)
- Craniofacial malformation affecting the orbits
- Prior extraocular muscle surgery or intraocular surgery
- Structural ocular abnormalities (e.g. media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment)
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00310960
Start Date
June 1 2004
End Date
May 1 2008
Last Update
September 2 2011
Active Locations (1)
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1
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455