An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia

• 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.

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 the first few months of their initial examination. In approximately two thirds of patients, the angle of misalignment remains stable and in a small proportion, the angle of esotropia decreases. The changing angle of misalignment in a significant proportion of children with esotropia raises an important question regarding the timing of surgical management of these children: should surgery be undertaken immediately or delayed until the alignment stabilizes? Early surgery may improve sensory outcomes; delayed surgery may improve surgical dosing accuracy and motor outcomes.

Children with acquired partially accommodative esotropia (APAET) may differ from those with infantile ET and ANAET in that they tend to present at an older age, are more likely to preserve high-grade stereopsis with appropriate treatment, require surgical intervention less frequently, and have more substantial hyperopic refractive errors. Little is known regarding early angle stability in this group of patients following correction of their refractive errors.

Eligible patients with infantile ET will be consented and enrolled at their initial visit. Infantile ET patients who need spectacles will be prescribed spectacles and will return for an Infantile ET Spectacle Baseline Visit 2 weeks later.

ANAET and APAET patients who present wearing spectacles with appropriate correction for at least 2 weeks will be consented and enrolled into the study at that initial visit.

• Patients who do not need spectacles will be consented and enrolled into the study at that initial visit.
• Patients who need spectacles are prescribed appropriate correction if the investigator intends to offer the patient enrollment at a later date. Patients are asked to return after wearing the new spectacles 2-6 weeks, at which time they may be consented and enrolled into the study.

Sample Size: The study will enroll 100 patients for each of the three esotropia types of infantile ET, ANAET, and APAET, for a total of 300 patients.

1. Age at enrollment:
a) For infantile ET: less than 12 months old
b) For ANAET or APAET: 6 months to <5 years old
2. Duration of esotropia less than 6 months by best estimate (photos, parent history, physician records)
3. A constant or variable* esotropia meeting the following criteria:
For infantile ET:
a) Onset before six months of age
b) Measuring >10 PD by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation on an accommodative target
For ANAET:
a) Onset after six months of age
b) Angle decreases less than 10 prism diopters (PD) by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
c) Residual angle measures >10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
For APAET:
a) Onset after six months of age
b) Angle decreases 10 prism diopters (PD) or more by Alternate Prism and Cover Test (APCT) in the primary position at distance fixation with correction
c) Residual angle measures >10 PD by Simultaneous Prism and Cover Test (SPCT) in the primary position at distance fixation
*The deviation can be variable if the minimum angle meets the above criteria, however, a patient whose deviation is intermittent on any measurement is ineligible.
4. Spectacle correction history
a) For infantile ET: no prior spectacle wear
b) APAET or ANAET:
i) For patients who have significant refractive error, full hyperopic correction determined with cycloplegia must have been worn for at least 2 weeks.
ii) 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.
5. Gestational age > 34 weeks
6. Birth weight > 1500 grams
7. No atropine use within the last two weeks
8. No history of CNS disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalasia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy)
9. No significant developmental delay in the investigator’s judgment (isolated speech delay excepted)
10. No limitation of abduction consistent with paralytic or restrictive myopathy (minor limitation of abduction due to cross fixation is acceptable)
11. No craniofacial malformation affecting the orbits
12. No prior extraocular muscle surgery or intraocular surgery
13. No structural ocular abnormalities (e.g. media opacity, optic atrophy, optic nerve hypoplasia, retinal detachment)

No longer recruiting. Comments: Recruitment started June 2004 and ended May 31, 2007 with 293 patients enrolled.

Ongoing. Comments:

None