An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
Completed
Conditions studied: Infantile Esotropia, Acquired Non-accommodative Esotropia, Acquired Partially Accommodative Esotropia
In brief
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 partially accommodative esotropia (APAET). * To determine the proportion of patients with angle instability in infantile ET, ANAET and APAET by length of follow-up.
Key facts
- Study ID
- NCT00310960
- Run by
- Jaeb Center for Health Research
- People needed
- 293
- Starts
- 2004-06-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2011-09-02
Who can join
Age: any, up to 4. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of Minnesota Medical School — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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