Early Versus Delayed Surgery for Infantile Esotropia

Completed

• Conditions: Esotropia
• Interventions: Procedure: mVEP Testing; Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: Motion discrimination testing

• Registration Number: NCT01166503
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-21
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-26
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. onset of esotropia after 10 weeks of age;
2. constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
3. refractive error ≤ +3.00 diopters (far-sightedness).

Exclusion Criteria

1. gestational age < 34 weeks;
2. birth weight ≤ 1500 g;
3. ventilator treatment in the newborn period;
4. history of meningitis or other major medical event;
5. developmental delay;
6. incomitant or paralytic strabismus;
7. manifest nystagmus or head bobbing;
8. prior eye muscle surgery;
9. prior treatment of amblyopia or spectacle correction for refractive errors;
10. presence of structural ocular anomalies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early Surgery	Motion discrimination testing	This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.
Standard Surgery	Motion detection testing	This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.
Early Surgery	Stereoacuity Testing	This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.
Standard Surgery	mVEP Testing	This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.
Standard Surgery	Optokinetic nystagmus testing	This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.
Early Surgery	Motion detection testing	This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.
Standard Surgery	Stereoacuity Testing	This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.
Early Surgery	mVEP Testing	This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.
Early Surgery	Optokinetic nystagmus testing	This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.
Standard Surgery	Motion discrimination testing	This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.

Primary Outcome Measures

Name	Time	Method
Optokinetic nystagmus (OKN) asymmetry	at age 5 years	OKN is measured in both the nasalward and temporalward directions for each eye. From this a nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better in one direction or the other.
Motion visual evoked potential (mVEPs) asymmetry	at age 2 years	mVEP measures the perception of nasalward and temporalward motion for each eye at the cortical level. A nasal bias index (NBI) is calculated, which will show whether subjects perceive motion better for one direction over the other.
Global Motion Perception	at 2 and 5 years of age	Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).
Stereopsis	at 2 and 5 years of age	This measures the level of 3D depth perception.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada