Skip to content

Early Versus Delayed Surgery for Infantile Esotropia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01166503
Enrollment
71
Registered
2010-07-21
Start date
2004-05-31
Completion date
2018-04-26
Last updated
2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esotropia

Keywords

pediatrics, Esotropia, Surgery

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 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.

Interventions

PROCEDUREmVEP 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.

PROCEDUREStereoacuity Testing

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

PROCEDUREOptokinetic 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.

PROCEDUREMotion 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).

PROCEDUREMotion 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).

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 23 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Motion visual evoked potential (mVEPs) asymmetryat age 2 yearsmVEP 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.
Stereopsisat 2 and 5 years of ageThis measures the level of 3D depth perception.
Optokinetic nystagmus (OKN) asymmetryat age 5 yearsOKN 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 Perceptionat 2 and 5 years of ageMotion perception will be tested using two tasks: motion detection (at age 2 and 5 years) and motion discrimination (at age 5 years).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026