Eye muscle surgery showdown: which fix for wandering eyes works best?

NCT ID NCT01032603

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

197 people

The number who actually took part.

Started

Jun 2010

Finished

Feb 2022

Lead sponsor

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

3 to 10 years

Sex

Anyone

Healthy volunteers

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

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

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232-8808, United States

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