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 range

3 Months – 23 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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