Early Versus Delayed Surgery for Infantile Esotropia

NCT01166503 | Completed

• 1 other identifier: 1000005134
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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).

Conditions

Esotropia

Keywords

pediatrics; Esotropia; Surgery

Outcome Measures

Primary Outcomes (4)

• Motion visual evoked potential (mVEPs) asymmetry

  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.

  at age 2 years

• Stereopsis

  This measures the level of 3D depth perception.

  at 2 and 5 years of age

• Optokinetic nystagmus (OKN) asymmetry

  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.

  at age 5 years

• Global Motion Perception

  Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).

  at 2 and 5 years of age

Study Arms (2)

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.

Procedure: mVEP Testing; Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: Motion discrimination testing

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.

Procedure: mVEP Testing; Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: Motion discrimination testing

Interventions

mVEP Testing 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.

Early Surgery; Standard Surgery

Stereoacuity Testing PROCEDURE

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

Early Surgery; Standard Surgery

Optokinetic nystagmus testing 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.

Early Surgery; Standard Surgery

Motion detection testing 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).

Early Surgery; Standard Surgery

Motion discrimination testing 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).

Early Surgery; Standard Surgery

Eligibility Criteria

• Age: 3 Months - 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in Toronto. Infants with characteristics that indicate low likelihood of spontaneous resolution will be studied.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Agnes Wong, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthamologist-In-Chief

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: May 1, 2004
• Primary Completion: April 2, 2018
• Study Completion: April 26, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)