Early Versus Delayed Surgery for Infantile Esotropia

NCT ID: NCT01166503

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 71 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2018-04-26

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.

Conditions

Esotropia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Surgery

This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.

mVEP Testing

Intervention Type: PROCEDURE

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.

Stereoacuity Testing

Intervention Type: PROCEDURE

Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).

Optokinetic nystagmus testing

Intervention Type: PROCEDURE

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.

Motion detection testing

Intervention Type: PROCEDURE

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).

Motion discrimination testing

Intervention Type: PROCEDURE

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).

Standard Surgery

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.

mVEP Testing

Intervention Type: PROCEDURE

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.

Stereoacuity Testing

Intervention Type: PROCEDURE

Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).

Optokinetic nystagmus testing

Intervention Type: PROCEDURE

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.

Motion detection testing

Intervention Type: PROCEDURE

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).

Motion discrimination testing

Intervention Type: PROCEDURE

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).

Interventions

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.

Intervention Type: PROCEDURE

Stereoacuity Testing

Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Agnes Wong

Ophthamologist-In-Chief

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Agnes Wong, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000005134

Identifier Type: -

Identifier Source: org_study_id