Status:
COMPLETED
Early Versus Delayed Surgery for Infantile Esotropia
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Esotropia
Eligibility:
All Genders
3-23 years
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 (c...
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 typ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2018
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01166503
Start Date
May 1 2004
End Date
April 26 2018
Last Update
June 12 2018
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8