Clinical Trial: Early Versus Delayed Surgery for Infantile Esotropia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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).

Detailed Summary: 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.
Sponsor: The Hospital for Sick Children

Current Primary Outcome:

• 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.
• Stereopsis [ Time Frame: at 2 and 5 years of age ]
  This measures the level of 3D depth perception.
• 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.
• 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).

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Hospital for Sick Children

Dates:
Date Received: July 19, 2010
Date Started: May 2004
Date Completion: May 2018
Last Updated: May 8, 2017
Last Verified: May 2017