Clinical Trial: An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
Brief 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.
Detailed Summary:
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 tri
Sponsor: Jaeb Center for Health Research
Current Primary Outcome:
- Determination of angle instability [ Time Frame: 18 weeks ]
- Estimation of misalignment [ Time Frame: 10 months ]
Original Primary Outcome:
- Determination of angle instability
- Estimation of misalignment
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Jaeb Center for Health Research
Dates:
Date Received: April 3, 2006
Date Started: June 2004
Date Completion:
Last Updated: August 31, 2011
Last Verified: August 2011
