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Congenital Esotropia Observational Study (CEOS)

2014-07-23 22:00:27 | BioPortfolio

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.

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 ophthalmologist's usual routine, and no additional procedures are being performed specifically for the study. Management of refractive error and amblyopia is left to the ophthalmologist's discretion. A sample size of 150 has been projected for the study.

Study Design

N/A

Conditions

Esotropia

Status

Completed

Source

National Eye Institute (NEI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T22:00:27-0400

Clinical Trials [4 Associated Clinical Trials listed on BioPortfolio]

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 (ANA...

Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin

To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

The Prism Adaptation Study (PAS)

To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of surgery for acquired esotropia, a type of strabismus. To determine whether patients who respon...

Botox Instead of Strabismus Surgery (BISS)

The purpose of the study is to evaluate if strabismus can be successfully treated requiring less surgical interventions with a Botox-based treatment regimen compared to a purely surgery ba...

PubMed Articles [12 Associated PubMed Articles listed on BioPortfolio]

Accommodative esotropia: the state of the art.

To review the state of the art of Accommodative Esotropia (AE) through careful study of what has been reported up to the point in literature.

Time and Factors Affecting the Direction of Re-drift in Essential Infantile Esotropia.

To investigate the development pattern and related factors of postoperative re-drift in infantile esotropia.

The Use of Botulinum Toxin to Treat Infantile Esotropia: A Systematic Review With Meta-Analysis.

The purpose of this review was to examine the efficacy of botulinum toxin in the treatment of infantile esotropia and to evaluate the average response of BT and its complication rates.

Long-term surgical outcomes for large-angle, infantile esotropia.

To report the long-term surgical outcomes for a cohort of children with large-angle, infantile esotropia.

The effect of botulinum toxin-augmentation on strabismus surgery for large-angle, infantile esotropia.

To determine whether botulinum toxin augments the effect of strabismus surgery in pediatric patients with large-angle, infantile esotropia.

Medical and Biotech [MESH] Definitions

A form of ocular misalignment characterized by an excessive convergence of the visual axes, resulting in a "cross-eye" appearance. An example of this condition occurs when paralysis of the lateral rectus muscle causes an abnormal inward deviation of one eye on attempted gaze.

Diseases of the sixth cranial (abducens) nerve or its nucleus in the pons. The nerve may be injured along its course in the pons, intracranially as it travels along the base of the brain, in the cavernous sinus, or at the level of superior orbital fissure or orbit. Dysfunction of the nerve causes lateral rectus muscle weakness, resulting in horizontal diplopia that is maximal when the affected eye is abducted and ESOTROPIA. Common conditions associated with nerve injury include INTRACRANIAL HYPERTENSION; CRANIOCEREBRAL TRAUMA; ISCHEMIA; and INFRATENTORIAL NEOPLASMS.

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