Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Eye Institute (NEI) |
---|---|
Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00310960 |
The purpose of this study is to:
Condition | Phase |
---|---|
Infantile Esotropia Acquired Non-Accommodative Esotropia Acquired Partially Accommodative Esotropia |
Phase III |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | An Observational Study of Infantile, Acquired Non-Accommodative, and Acquired Partially-Accommodative Esotropia |
Enrollment: | 293 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | May 2008 |
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 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.
Ages Eligible for Study: | up to 4 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Community sample
Inclusion Criteria:
For infantile ET:
For ANAET:
For APAET:
Exclusion Criteria:
For infantile ET:
For infantile ET,ANAET,APAET:
United States, Minnesota | |
University of Minnesota Medical School | |
Minneapolis, Minnesota, United States, 55455 |
Study Chair: | Stephen P. Christiansen, M.D. | University of Minnesota |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D., Executive Director ) |
Study ID Numbers: | NEI-102, 5-U10 EY 11751 |
Study First Received: | April 3, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00310960 History of Changes |
Health Authority: | United States: Federal Government |
infantile esotropia acquired non-accommodative esotropia acquired partially accommodative esotropia |
Esotropia Ocular Motility Disorders Eye Diseases Strabismus Motor Neuro-ophthalmic Disorders |
Esotropia Ocular Motility Disorders Eye Diseases |
Nervous System Diseases Strabismus Cranial Nerve Diseases |