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Early Versus Delayed Surgery for Infantile Esotropia

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Agnes Wong, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01166503
First received: July 19, 2010
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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).


Condition Intervention Phase
Esotropia
Procedure: mVEP Testing
Procedure: Stereoacuity Testing
Procedure: Optokinetic nystagmus testing
Procedure: Motion detection testing
Procedure: Motion discrimination testing
Phase 1
Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Early Versus Delayed Surgery for Infantile Esotropia: A Clinical Evaluation of Sensory and Motor Outcomes

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Motion visual evoked potential (mVEPs) asymmetry [ Time Frame: at age 2 years ] [ Designated as safety issue: No ]
    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.

  • Stereopsis [ Time Frame: at 2 and 5 years of age ] [ Designated as safety issue: No ]
    This measures the level of 3D depth perception.

  • Optokinetic nystagmus (OKN) asymmetry [ Time Frame: at age 5 years ] [ Designated as safety issue: No ]
    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.

  • Global Motion Perception [ Time Frame: at 2 and 5 years of age ] [ Designated as safety issue: No ]
    Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).


Estimated Enrollment: 60
Study Start Date: May 2004
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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).
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
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).

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.

  Eligibility

Ages Eligible for Study:   3 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166503

Contacts
Contact: Linda Colpa, O.C.(C) 416-813-7654 ext 28104 linda.colpa@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Linda Colpa, O.C.(C)    (416) - 813 - 7654 ext 28104    linda.colpa@sickkids.ca   
Principal Investigator: Agnes Wong, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Agnes Wong, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Agnes Wong, Ophthamologist-In-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01166503     History of Changes
Other Study ID Numbers: 1000005134
Study First Received: July 19, 2010
Last Updated: November 18, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
pediatrics
Esotropia
Surgery

Additional relevant MeSH terms:
Esotropia
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Ocular Motility Disorders
Strabismus

ClinicalTrials.gov processed this record on November 25, 2014