Eye muscle surgery showdown: which fix for wandering eyes works best?
NCT ID NCT01032603
First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This trial compares two common surgical procedures for intermittent exotropia, a condition where one eye occasionally turns outward. Children aged 3 to 10 with basic or pseudo-divergence excess type exotropia are randomly assigned to receive either bilateral lateral rectus recession (both eyes) or unilateral recession with medial rectus resection (one eye). The study tracks eye alignment and depth perception over three years to determine which surgery yields better long-term results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgery (eye muscle recession and resection)
- What this could lead to
- If one procedure proves more effective, it could become the preferred surgical approach for treating intermittent exotropia in children, improving long-term eye alignment and depth perception.
- What could go wrong
- This is a surgical trial with inherent risks like overcorrection, undercorrection, or need for repeat surgery. Results may not apply to all types of exotropia or older patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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197 people
The number who actually took part.
- Started
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Jun 2010
- Finished
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Feb 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 10 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 3 to \< 11 years * Intermittent exotropia (manifest deviation) meeting all of the following: * Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near * Largest exodeviation at either distance, near OR remote distance between 15 and 50 prism diopters (PD) (inclusive) by prism and alternate cover test (PACT) * Exodeviation at least 15 PD at distance and near by PACT * Basic type or pseudo divergence excess type * Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of 2 measures) * Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) * No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS testing) * Absence of high AC/A ratio (exclude \> 6:1) * No previous intraocular surgery, strabismus surgery, or botulinum toxin treatment * Investigator planning to perform surgery for correction of IXT * No hyperopia greater than +3.50 D spherical equivalent (SE) in either eye Exclusion Criteria: * Coexisting vertical deviation, oblique muscle dysfunction, dissociated vertical deviation (DVD), or A or V pattern, any of which the investigator plans to address with vertical transposition of horizontal rectus muscles, oblique surgery, or vertical rectus muscle surgery, i.e., only small vertical deviations, oblique muscle dysfunction, DVD, and A or V patterns not requiring surgery are allowed * Limitation of ocular rotations due to restrictive or paretic strabismus * Craniofacial malformations affecting the orbits * Interocular visual acuity difference of more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to \< 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old) and/or investigator plans to initiate amblyopia treatment at this time. * High AC/A ratio (exclude \> 6:1 by gradient method) * Prior strabismus surgery or botulinum toxin injection * Ocular disorders that would reduce visual acuity (except refractive error) * Prior intraocular or refractive surgery * Significant neurological impairment such as cerebral palsy. Patients with mild speech and/or learning disabilities are eligible. * Investigator planning to change refractive correction at this time (if the patient is otherwise eligible, the investigator should consider prescribing refractive correction and bringing the patient back at a later time for enrollment).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-8808, United States
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Other studies related to the condition(s) this trial covers.
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