Information obtained from ClinicalTrials.gov on September 02, 2010
Link to the current ClinicalTrials.gov record.
Early Versus Delayed Surgery for Infantile Esotropia
Status: Recruiting
Verified by: The Hospital for Sick Children, July 2010
Last Updated: July 19, 2010
Sponsor: The Hospital for Sick Children
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: Esotropia
Study Type: Observational
Study Design: Observational Model: Case Control, Time Perspective: Prospective
Intervention: Procedure: mVEP Testing
Intervention: Procedure: Stereoacuity Testing
Intervention: Procedure: Optokinetic nystagmus testing
Intervention: Procedure: Motion detection testing
Intervention: Procedure: Motion discrimination testing
Phase: Phase 1/Phase 2
Primary Outcome Measures:
- Motion visual evoked potential (mVEPs) asymmetry
- Stereopsis
- Optokinetic nystagmus (OKN) asymmetry
- Global Motion Perception
Estimated Enrollment: 60
Start Date: May 2004
Primary Completion Date: May 2015
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
Minimum Age: 3 Months
Maximium Age: 23 Months
Accepts Healthy Volunteers: No
Gender: Both
Sampling Method: Non-Probability Sample
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.
Location and Contacts
Contact: Agnes Wong, MD, Principal Investigator, The Hospital for Sick Children, Toronto Canada
Contact: Linda Colpa, O.C.(C), Principal Investigator, The Hospital for Sick Children, Toronto Canada, 416-813-7654, linda.colpa@sickkids.ca
The Hospital for Sick Children
Toronto,
Ontario,
M5G 1X8
Canada