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Completed

NCT Number: NCT01166503

Early Versus Delayed Surgery for Infantile Esotropia

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).

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Key information

Conditions

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

Age range

3 month–23 month

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Stereoacuity Testing

Procedure

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

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.

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).

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).

Primary outcomes

  1. Motion visual evoked potential (mVEPs) asymmetry

    Time frame: 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.

  2. Stereopsis

    Time frame: at 2 and 5 years of age

    This measures the level of 3D depth perception.

  3. Optokinetic nystagmus (OKN) asymmetry

    Time frame: 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.

  4. Global Motion Perception

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2010
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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