Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00310960
Eligibility Criteria:
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 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 Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
4 Years
Study:
NCT00310960
Study Brief:
Protocol Section:
NCT00310960