CompletedNot Applicable

Early Versus Delayed Surgery for Infantile Esotropia

Canada71 participantsStarted 2004-05

Plain-language 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).

Who can participate

Age range3 Months – 23 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Motion visual evoked potential (mVEPs) asymmetry

Timeframe: at age 2 years

Stereopsis

Timeframe: at 2 and 5 years of age

Optokinetic nystagmus (OKN) asymmetry

Timeframe: at age 5 years

Global Motion Perception

Timeframe: at 2 and 5 years of age

Trial details

NCT IDNCT01166503

SponsorThe Hospital for Sick Children

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04-02

View on ClinicalTrials.gov More Esotropia trials