Infantile Esotropia Clinical Trial
Official title:
An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
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.
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.
Although there is a need for a randomized trial to address the issue of timing of surgery in
infantile ET, APAET, and ANAET, prior to designing such a trial, high-quality preliminary
data are needed. We propose a multi-center observational study to 1) determine the duration
of misalignment in infantile ET, ANAET, and APAET at study enrollment, 2) to prospectively
establish the proportion of patients with angle instability in infantile ET, ANAET, and
APAET, and 3) to determine recruitment potential for a randomized trial. These data will be
crucial for sample size calculations for the eventual randomized trial, and will help
further define the clinical characteristics of these conditions.
A concurrent and nested ancillary study will be conducted at selected centers to collect
test-retest data on alignment measurements for estimating the amount of measurement
variability. These test-retest data will be used to define a change in angle alignment that
exceeds an amount which could reasonably be due to measurement error, which will be used in
evaluating the proportion of patients with angle instability in the current study.
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.
For ANAET and APAET patients who present not wearing spectacles:
- 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.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06221098 -
Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
|
N/A |