Early Versus Delayed Surgery for Infantile Esotropia

Esotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166503
• Other study ID #: 1000005134
• Status: Completed
• Start date: May 2004
• Est. completion date: April 26, 2018

Study information

• Verified date: June 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 26, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 23 Months

Eligibility

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.

Related Conditions & MeSH terms

• Esotropia

Intervention

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

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motion visual evoked potential (mVEPs) asymmetry	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.	at age 2 years
Primary	Stereopsis	This measures the level of 3D depth perception.	at 2 and 5 years of age
Primary	Optokinetic nystagmus (OKN) asymmetry	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.	at age 5 years
Primary	Global Motion Perception	Motion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).	at 2 and 5 years of age