Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000163
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Congenital Esotropia Observational Study CEOS
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To observe the early course of congenital esotropia a form of childhood strabismus This will determine the probability of spontaneous resolution Researchers then will try to correlate this finding with various aspects of the esotropia such as the 1 size of the esotropia 2 variability and 3 presence of hyperopia This information will be used to determine the feasibility of conducting a clinical trial to assess the benefit of early surgery for congenital esotropia and if feasible to refine eligibility criteria for the trial
Detailed Description:
Congenital esotropia is the most common form of childhood strabismus Despite its common occurrence limited information is available about its early clinical course Such data are needed to determine the earliest age at which surgery can be safely performed without concern that the esotropia is likely to resolve spontaneously Although the term congenital esotropia implies that the esotropia is present at birth in many cases the esotropia actually develops sometime during the first few months of life It is well recognized that congenital esotropia persisting through 6 months of age rarely if ever resolves spontaneously and therefore requires surgical correction However it is not clear how often congenital esotropia occurs and then resolves at an earlier age such that surgery is not necessary before surgery is required
Current clinical practice is to defer surgery for congenital esotropia until 6 to 12 months of age Assuming that characteristics of congenital esotropia at 2 to 4 months of age can be identified to predict which cases will require surgery then a trial will be warranted to determine whether performing earlier surgery enhances the development of binocular vision The potential benefit to very early surgery is supported by neurophysiologic research which has shown that 1 congenital esotropes may be born with the innate ability to develop binocular vision 2 there is a critical period for development of normal binocular function within the first few months of life that is dependent on alignment of the visual axes of the two eyes and 3 ocular misalignment alone regardless of its mechanism without a coexisting primary cortical fusion deficit can account for abnormal development of binocular vision Clinical reports have demonstrated that surgical correction of the esotropia between 6 and 12 months of age provides for enhanced development of stereoacuity compared with later surgery However there are limited data on the outcomes in infants who had surgical correction before age 6 months
The protocol for the study is identical to usual clinical practice Following informed consent two followup visits are conducted one 2 to 4 weeks after the first examination and the other when the child is between 28 and 32 weeks of age The examinations will be identical to the pediatric ophthalmologists usual routine and no additional procedures are being performed specifically for the study Management of refractive error and amblyopia is left to the ophthalmologists discretion A sample size of 150 has been projected for the study
Current clinical practice is to defer surgery for congenital esotropia until 6 to 12 months of age Assuming that characteristics of congenital esotropia at 2 to 4 months of age can be identified to predict which cases will require surgery then a trial will be warranted to determine whether performing earlier surgery enhances the development of binocular vision The potential benefit to very early surgery is supported by neurophysiologic research which has shown that 1 congenital esotropes may be born with the innate ability to develop binocular vision 2 there is a critical period for development of normal binocular function within the first few months of life that is dependent on alignment of the visual axes of the two eyes and 3 ocular misalignment alone regardless of its mechanism without a coexisting primary cortical fusion deficit can account for abnormal development of binocular vision Clinical reports have demonstrated that surgical correction of the esotropia between 6 and 12 months of age provides for enhanced development of stereoacuity compared with later surgery However there are limited data on the outcomes in infants who had surgical correction before age 6 months
The protocol for the study is identical to usual clinical practice Following informed consent two followup visits are conducted one 2 to 4 weeks after the first examination and the other when the child is between 28 and 32 weeks of age The examinations will be identical to the pediatric ophthalmologists usual routine and no additional procedures are being performed specifically for the study Management of refractive error and amblyopia is left to the ophthalmologists discretion A sample size of 150 has been projected for the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None