NCT01166503

Early Versus Delayed Surgery for Infantile Esotropia

Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 3 Months – 23 Months
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).

Detailed description

While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.

Conditions

• Esotropia

Interventions

Type	Name	Description
PROCEDURE	mVEP Testing	Five small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye.
PROCEDURE	Stereoacuity Testing	Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).
PROCEDURE	Optokinetic nystagmus testing	Subjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker.
PROCEDURE	Motion detection testing	Subjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
PROCEDURE	Motion discrimination testing	Subjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).

Timeline

• Start date: 2004-05-01
• Primary completion: 2018-04-02
• Completion: 2018-04-26
• First posted: 2010-07-21
• Last updated: 2018-06-12

Locations

1 site across 1 country: Canada