An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommoda… (NCT00310960) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
United States293 participantsStarted 2004-06
Plain-language 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 partially accommodative esotropia (APAET).
* To determine the proportion of patients with angle instability in infantile ET, ANAET and APAET by length of follow-up.
Who can participate
Age range4 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 es…